| Trial | Phase | Enrollment | Study Type | Start Date | Status |
|---|
| A Randomized, Phase 2, Open Label Study Evaluating Subcutaneous Administration of Isatuximab in Combination With Carfilzomib and Dexamethasone in Adult Participants With Relapsed and/or Refractory Multiple Myeloma (RRMM) [NCT05704049] | Phase 2 | 68 participants (Anticipated) | Interventional | 2023-04-05 | Recruiting |
| Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation [NCT01588925] | Phase 2 | 18 participants (Actual) | Interventional | 2011-11-30 | Completed |
| A Phase II/III Study of N-803 (ALT-803) Plus Pembrolizumab Versus Standard of Care in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer Previously Treated With Anti-PD-1 or Anti-PD-L1 Therapy (Lung-MAP Non-Match Sub-Study) [NCT05096663] | Phase 2/Phase 3 | 82 participants (Actual) | Interventional | 2022-03-15 | Active, not recruiting |
| A Randomized, Double-Blind, Parallel-Group Study Conducted Under In-House Blinding Conditions to Determine the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy Induced Nausea and Vomiting (CINV) Associated With Moderately Emetoge [NCT00337727] | Phase 3 | 848 participants (Actual) | Interventional | 2007-01-01 | Completed |
| A RANDOMIZED CONTROLLED MULTICENTER NON-INFERIORITY TRIAL OF TWICE DAILY LOW DOSE DEXAMETHASONE VERSUS USUAL DOSE DEXAMETHASONE FOR SYMPTOM CONTROL IN CHILDREN WITH A BRAIN TUMOUR UNDERGOING CRANIAL OR CRANIOSPINAL RADIATION [NCT01135550] | Phase 3 | 25 participants (Actual) | Interventional | 2010-06-30 | Terminated(stopped due to premature closure due to lack of accrual) |
| Evaluations of Effects of Intra-Erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Ataxia Teleangiectasia Patients [NCT01255358] | Phase 2 | 22 participants (Actual) | Interventional | 2011-02-28 | Completed |
| A Phase 2 Trial of Leflunomide, Pomalidomide, and Dexamethasone for Relapsed/Refractory Multiple Myeloma [NCT04508790] | Phase 2 | 29 participants (Anticipated) | Interventional | 2020-11-27 | Recruiting |
| Impact of Intrathecal Dexamethasone Administration for Elderly Patients With Proximal Femoral Fracture [NCT03856502] | | 60 participants (Actual) | Interventional | 2012-11-11 | Completed |
| A Phase 1/2 Study of MLN9708 (Ixazomib [I]), Venetoclax (V), and Dexamethasone (D) Regimen (IVD) to Restore or Enhance Proteasome Inhibitor (PI) Sensitivity in Non-t(11;14) Relapsed/Refractory Multiple Myeloma (RRMM) [NCT03856112] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2019-06-21 | Withdrawn(stopped due to Per CTEP, Martha Khrum this study is withdrawn. Changing status to update CT.gov) |
| Dexamethasone Compared to Ondansetron and Dexamethasone for Prophylaxis of Postoperative Vomiting in Children Undergoing Ambulatory Surgery: Clinical Trial Randomized, Double Blind, Placebo-controlled [NCT01297010] | Phase 3 | 134 participants (Actual) | Interventional | 2011-03-31 | Completed |
| An Open Label, Randomized Phase 2 Trial of Pomalidomide/Dexamethasone With or Without Elotuzumab in Relapsed and Refractory Multiple Myeloma (ELOQUENT-3) [NCT02654132] | Phase 2 | 117 participants (Actual) | Interventional | 2016-03-18 | Completed |
| Efficacy of First Line Dexamethasone, Rituximab and Cyclophosphamide (DRC) +/- Bortezomib for Patients With Waldenström's Macroglobulinemia [NCT01788020] | Phase 3 | 202 participants (Actual) | Interventional | 2013-11-30 | Active, not recruiting |
| The Effects of Dexamethasone on the Duration of Sciatic Nerve Blocks [NCT00616603] | | 43 participants (Actual) | Interventional | 2007-08-31 | Terminated(stopped due to PI is no longer here.) |
| Phase 2 Trial of Pembrolizumab, Ixazomib, and Dexamethasone for Relapsed Multiple Myeloma [NCT03506360] | Phase 2 | 13 participants (Actual) | Interventional | 2018-06-19 | Completed |
| Study of the Effects of Dexamethasone on Non-Small Cell Lung Cancer Using [F-18] FLT for Imaging With Positron Emission Tomography (PET) [NCT02819024] | | 6 participants (Actual) | Interventional | 2016-06-30 | Active, not recruiting |
| Bevacizumab Versus DEX Implant Followed by Bevacizumab in ME Secondary to BRVO [NCT03892434] | Phase 4 | 40 participants (Anticipated) | Interventional | 2019-03-18 | Recruiting |
| A Multicentre, Randomized, Open-label Study of Romiplostim Plus Dexamethasone vs Dexamethasone in Patients With Newly Diagnosed Primary Immune Thrombocytopenia [NCT05325593] | Phase 3 | 126 participants (Anticipated) | Interventional | 2022-12-02 | Recruiting |
| Role of Adjuvant Dexamethasone for Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy: A Randomized, Double-blind Controlled Trial [NCT03769818] | | 150 participants (Actual) | Interventional | 2019-01-01 | Completed |
| A Phase Ⅰ Clinical Study of Mitoxantrone Hydrochloride Liposome Injection in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma [NCT05052970] | Phase 1 | 60 participants (Anticipated) | Interventional | 2021-10-20 | Recruiting |
| Pediatric Postoperative Analgesia With Quadratus Lumborum Block And Dexamethasone As An Adjuvant In Two Routes With Bupivacaine. Prospective Controlled Clinical Trial [NCT04963816] | | 3 participants (Actual) | Interventional | 2021-06-16 | Completed |
| A Pilot Study to Evaluate the Safety and Efficacy of Aprepitant in Combination With Dolasetron and Dexamethasone for the Prevention of Nausea and Vomiting Following Oxaliplatin-containing Regimen Which Includes 5-FU. [NCT02550119] | | 19 participants (Actual) | Interventional | 2006-04-19 | Terminated(stopped due to Insufficient accrual) |
| Phase II Study of the Combination of Low-Intensity Chemotherapy and Blinatumomab in Patients With Philadelphia Chromosome Negative Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) [NCT03518112] | Phase 2 | 6 participants (Actual) | Interventional | 2018-04-18 | Terminated(stopped due to Due to Competing Studies) |
| A Phase 1, Open-Label, Randomized Study to Compare the Pharmacokinetics and Pharmacodynamics of Single Dose Dexamethasone and Betamethasone Administered Orally and Intramuscularly in Healthy Female Subjects [NCT03668860] | Phase 1 | 48 participants (Actual) | Interventional | 2018-09-20 | Completed |
| Role Of Dexamethasone In Induction Of Labor : A Randomized Clinical Trial . [NCT03603418] | Phase 4 | 80 participants (Anticipated) | Interventional | 2018-07-13 | Recruiting |
| Comparison of the Effects of Adding Dexamethasone at 0.25% Ropivacaine With 0.5% Ropivacaine Alone in the Supraclavicular Brachial Plexus Block [NCT03572686] | | 90 participants (Anticipated) | Interventional | 2018-04-13 | Enrolling by invitation |
| Effects of Dexamethasone Tapering Schedules on Functional Capacity and Neurocognition in Patients With Newly Diagnosed Glioblastoma Multiforme [NCT01169415] | | 0 participants (Actual) | Interventional | 2010-06-30 | Withdrawn(stopped due to Funding not obtained) |
| Reducing Respiratory Symptoms of Pulmonary Irradiation in Interstitial Lung Disease: A 2x2 Factorial Randomized Phase II Trial Testing N-Acetyl Cysteine and Dexamethasone [NCT05986318] | Phase 2 | 98 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
| A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL). [NCT05372315] | Phase 4 | 80 participants (Actual) | Interventional | 2022-06-15 | Completed |
| A Randomized Phase II, Open Label, Study of Daratumumab, Weekly Low-Dose Oral Dexamethasone and Cyclophosphamide With or Without Pomalidomide in Patients With Relapsed and Refractory Multiple Myeloma [NCT03215524] | Phase 2 | 120 participants (Actual) | Interventional | 2017-10-25 | Completed |
| Evaluation of Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of covid19 [NCT04425863] | | 167 participants (Actual) | Observational | 2020-05-01 | Completed |
| Can the Association of Dexamethasone and Local Anaesthetic in a Single-shot Femoral and Sciatic Nerve Block Improve Analgesia Postoperatively in Patients Submitted to Total Knee Arthroplasty [NCT02436694] | | 56 participants (Anticipated) | Interventional | 2015-04-30 | Recruiting |
| A Phase 1b, Open-label, Multicenter Study of (BMS-936564) in Combination With Lenalidomide (Revlimid) Plus Low-dose Dexamethasone, or With Bortezomib (Velcade) Plus Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma [NCT01359657] | Phase 1 | 46 participants (Actual) | Interventional | 2011-09-30 | Completed |
| A Phase II Study of Ibrutinib Plus Rituximab With Hyper-CVAD Consolidation in Newly Diagnosed Young Patients With Mantle Cell Lymphoma: A Window Period for Bioimmunotherapy Before Chemotherapy [NCT02427620] | Phase 2 | 131 participants (Anticipated) | Interventional | 2015-06-03 | Active, not recruiting |
| Intracochlear Dexamethasone Application During Cochlear Implantation for Preserving Cochlear Cells [NCT04397354] | | 34 participants (Actual) | Interventional | 2020-03-02 | Completed |
| Myeloma XIV: A Phase III Trial to Compare Standard and Frailty-adjusted Induction Therapy With Ixazomib, Lenalidomide and Dexamethasone (IRD) and Maintenance Lenalidomide (R) to Lenalidomide Plus Ixazomib (R+I) [NCT03720041] | Phase 3 | 740 participants (Anticipated) | Interventional | 2020-08-04 | Recruiting |
| Effect of Pre-Operative Dexamethasone Dose on the Post-Operative Management of Blood Sugar in Diabetic Patients [NCT03646916] | Phase 4 | 0 participants (Actual) | Interventional | 2020-09-15 | Withdrawn(stopped due to Lack of patients) |
| Triple Combination of Fosaprepitant, Dexamethasone and Palonosetron Versus Combination of Dexamethasone and Palonosetron for the Prevention of Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastrointestinal Surgery [NCT04853147] | Phase 3 | 1,154 participants (Actual) | Interventional | 2021-04-27 | Completed |
| An Open-label Phase I/II Trial of Venetoclax-Dexamethasone in Relapsed and/or Refractory t(11;14) Systemic Light-Chain Amyloidosis [NCT05451771] | Phase 1/Phase 2 | 53 participants (Anticipated) | Interventional | 2022-10-26 | Recruiting |
| A Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of Escalating Oral Doses of the Glutaminase Inhibitor CB-839 in Patients With Advanced and/or Treatment-Refractory Hematological Malignancies [NCT02071888] | Phase 1 | 25 participants (Actual) | Interventional | 2014-02-28 | Completed |
| The Effect of Topical Corticosteroids and Topical NSAIDs Perioperatively on IL6 Levels in Aqueous Humor and on Incidence of PCME in Patients With NPDR [NCT04940338] | Phase 4 | 90 participants (Actual) | Interventional | 2021-05-01 | Completed |
| A Single Center Phase Ib Study of Carfilzomib, Bendamustine, and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma [NCT02095834] | Phase 1 | 18 participants (Actual) | Interventional | 2014-04-24 | Completed |
| Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery [NCT03332316] | Phase 4 | 84 participants (Actual) | Interventional | 2017-11-02 | Completed |
| COX-2 Inhibitor Versus Glucocorticoid Versus Both Combined [NCT01361789] | Phase 4 | 93 participants (Actual) | Interventional | 2004-01-31 | Completed |
| The Role of Timing of Dexamethasone Administration on Pain Scores and Quality of Recovery in Cesarean Section. [NCT02112422] | | 40 participants (Actual) | Interventional | 2014-04-30 | Completed |
| CLBH589DUS108T: Panobinostat With Carfilzomib and Dexamethasone for Relapsed/Refractory Multiple Myeloma: Correlation With In Vitro Chemosensitivity Testing [NCT03256045] | Phase 2 | 9 participants (Actual) | Interventional | 2018-02-08 | Terminated(stopped due to Terminated due to loss of funding and former PI left the institution) |
| A Phase 2 Study of Blinatumomab (NSC# 765986) in Combination With Nivolumab (NSC # 748726), a Checkpoint Inhibitor of PD-1, in B-ALL Patients Aged >/= 1 to < 31 Years Old With First Relapse [NCT04546399] | Phase 2 | 550 participants (Anticipated) | Interventional | 2020-12-04 | Suspended(stopped due to Other - FDA Partial Clinical Hold) |
| Post-marketing Phase 4 Study to Evaluate Safety, Tolerability, and Efficacy of Kyprolis® (Carfilzomib) in Indian Patients With Relapsed or Refractory Multiple Myeloma: A Prospective, Open-label, Non-comparative, Multicenter Study [NCT03934684] | Phase 4 | 100 participants (Anticipated) | Interventional | 2019-09-16 | Active, not recruiting |
| A Randomized, Double-blind, Multicenter, Phase2 Trial to Evaluate the Safety and Efficacy of YH1177 or YH1177-D Otic Soultion in Patients With Otitis Media and Otorrhea [NCT02817347] | Phase 1/Phase 2 | 135 participants (Actual) | Interventional | 2016-06-30 | Terminated(stopped due to Sponsor's decision for the Drug Development.) |
| Phase 1/2 Trial of Ixazomib in Combination With Cyclophosphamide and Dexamethasone in Patients With Previously Untreated Symptomatic Multiple Myeloma or Light Chain Amyloidosis [NCT01864018] | Phase 1/Phase 2 | 87 participants (Actual) | Interventional | 2013-08-20 | Active, not recruiting |
| A Multi-center, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Different Doses of Dexamethasone for Management of Immune Thrombocytopenia (ITP) [NCT02153060] | Phase 2 | 58 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Phase II Trial of Daratumumab Retreatment in Patients With Relapsed Multiple Myeloma [NCT03841565] | Phase 2 | 0 participants (Actual) | Interventional | 2020-08-07 | Withdrawn(stopped due to There are no patients enrolled on this study and all efforts are being discontinued.) |
| A Multicenter Phase I Dose-finding and Preliminary Efficacy Study of the Histone Deacetylase Inhibitor Romidepsin (Istodax) in Combination With Gemcitabine (Gemzar), Oxaliplatin (Eloxatin), and Dexamethasone for the Treatment of Adults With Relapsed/Refra [NCT02181218] | Phase 1 | 24 participants (Actual) | Interventional | 2015-02-04 | Completed |
| An International, Multicenter, Randomized, Blinded-assessor, Parallel-group Clinical Study Comparing Eye Drops of Combined LEvofloxAcin + DExamethasone foR 7 Days Followed by Dexamethasone Alone for an Additional 7 Days vs. Tobramycin + Dexamethasone for [NCT03739528] | Phase 3 | 808 participants (Actual) | Interventional | 2018-09-03 | Completed |
| Comparison of Peritonsillar Infiltration of Ketamine and Dexamethasone for Postoperative Pain Relief in Children Following Adenotonsillectomy [NCT01198210] | Phase 1/Phase 2 | 160 participants (Anticipated) | Interventional | 2010-07-31 | Recruiting |
| Phase 1/2 Trial of Iberdomide in Combination With Daratumumab, BortEzomib and DexamethAsone in Patients With Newly Diagnosed Multiple MyeLoma (IDEAL) [NCT05392946] | Phase 1/Phase 2 | 18 participants (Anticipated) | Interventional | 2022-08-11 | Recruiting |
| Role of Co-administered Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section: A Randomized, Double-blind Controlled Trial [NCT03767920] | | 120 participants (Actual) | Interventional | 2019-01-01 | Completed |
| Aprepitant for Prevention of Acute and Delayed Nausea and Vomiting: a Phase III, Double-blind, Randomized, Placebo-controlled Trial in Patients Receiving a High-emetogenic Dose of Cyclophosphamide for Peripheral Blood Stem Cells Harvesting [NCT01088022] | Phase 3 | 120 participants (Anticipated) | Interventional | 2010-04-30 | Not yet recruiting |
| Effect of Dexamethasone on Postoperative Symptoms of Scleral Buckling Surgery Patients: a Randomized Control Trial [NCT01326585] | Phase 4 | 0 participants (Actual) | Interventional | 2011-04-30 | Withdrawn(stopped due to lack of funding) |
| A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment With an Intracanalicular Dexamethasone (0.4mg) Ophthalmic Insert in the Operating Room Following Cataract Surgery/Intraocular Lens Implant (IOL) Compared to Insertion 1-d [NCT05143281] | Phase 4 | 23 participants (Actual) | Interventional | 2021-12-13 | Completed |
| Daratumumab, Carfilzomib, Lenalidomide, and Dexamethasone in Newly-Diagnosed Multiple Myeloma: A Clinical and Correlative Phase II Study [NCT03290950] | Phase 2 | 75 participants (Actual) | Interventional | 2017-09-25 | Active, not recruiting |
| A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment W [NCT00060944] | Phase 2 | 271 participants (Actual) | Interventional | 2003-05-31 | Completed |
| A Phase 1b Multi-Center, Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Anti-Tumor Activity of an Alternative Liquid Formulation of ACY-1215 (Ricolinostat) In Combination With Pomalidomide and Low-Dose Dexamethasone [NCT02189343] | Phase 1 | 16 participants (Actual) | Interventional | 2014-09-15 | Completed |
| A Phase 1/2 Study of Ixazomib as a Replacement for Bortezomib or Carfilzomib for Multiple Myeloma (MM) Patients Recently Relapsed or Refractory to Their Last Combination Regimen Containing Either Bortezomib or Carfilzomib [NCT02206425] | Phase 1/Phase 2 | 45 participants (Actual) | Interventional | 2014-09-30 | Completed |
| Isatuximab, Carfilzomib, Pomalidomide, and Dexamethasone (Isa-KPd) for Patients With Relapsed/Refractory Multiple Myeloma [NCT04883242] | Phase 2 | 37 participants (Anticipated) | Interventional | 2021-07-29 | Recruiting |
| A Phase III Study for Patients With Newly Diagnosed Acute Promyelocytic Leukemia (APL) Using Arsenic Trioxide and All-Trans Retinoic Acid [NCT02339740] | Phase 3 | 158 participants (Actual) | Interventional | 2015-07-21 | Active, not recruiting |
| Phase II Study of Combination of Hyper-CVAD and Dasatinib (NSC-732517) With or Without Allogeneic Stem Cell Transplant in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) (A BMT Study) [NCT00792948] | Phase 2 | 97 participants (Actual) | Interventional | 2009-09-01 | Active, not recruiting |
| A Prospective Randomized Comparative Trial of Targeted Injection Via a Transforaminal Approach With Dexamethasone Versus an Epidural Catheter Via an Interlaminar Approach With Particulate Steroid for the Treatment of Cervical Radicular Pain [NCT03382821] | Phase 4 | 120 participants (Actual) | Interventional | 2017-09-15 | Completed |
| A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis [NCT00578955] | Phase 3 | 417 participants (Actual) | Interventional | 2007-12-31 | Completed |
| Impact of Perioperative Dexamethasone and Flurbiprofen Axetil on Delirium After Surgery for Non-small Cell Lung Cancer: A 2x2 Factorial Randomized Controlled Trial [NCT03200600] | Phase 4 | 126 participants (Actual) | Interventional | 2017-08-02 | Terminated(stopped due to Protocol violation occurred frequently during the postoperative period.) |
| Dexamethasone With TAP Block Increasing the Duration of the Peripheral Nerve Block in Caesarian Section [NCT02440880] | | 150 participants (Anticipated) | Interventional | 2015-05-31 | Recruiting |
| Impact of Perioperative Dexamethasone and Flurbiprofen Axetil on Long-term Survival After Surgery for Non-small Cell Lung Cancer: A 2x2 Factorial Randomized Controlled Trial [NCT03172988] | Phase 4 | 126 participants (Actual) | Interventional | 2017-08-02 | Terminated(stopped due to Protocol violation occurred frequently during the postoperative period.) |
| Intravenous Dexamethasone for Prolongation of Analgesia Following Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy: A Randomized, Controlled, Phase IV Dose-Response Study [NCT02688530] | Phase 4 | 140 participants (Actual) | Interventional | 2016-05-31 | Completed |
| A Randomized, Parallel Group, Double-masked, Active-controlled Phase 1/2 Clinical Trial to Evaluate the Efficacy and Safety of Dexamethasone Sodium Phosphate Visulex System for the Treatment of Non-infectious Anterior Uveitis [NCT02309385] | Phase 1/Phase 2 | 44 participants (Actual) | Interventional | 2014-10-31 | Completed |
| A Multicenter, Open-label, Safety and Proof-of-concept Study to Assess Safety, Tolerability and Efficacy of AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO) [NCT03739593] | Phase 2 | 49 participants (Actual) | Interventional | 2019-03-13 | Completed |
| The Effects of Intravitral Ozurdex Implant in DME: Cytokine Change in Aqueous Humor [NCT03475407] | Phase 4 | 20 participants (Anticipated) | Interventional | 2015-03-31 | Recruiting |
| A Phase II Study of Dasatinib (Sprycel®) (NSC #732517) as Primary Therapy Followed by Transplantation for Adults >/= 18 Years With Newly Diagnosed Ph+ Acute Lymphoblastic Leukemia by CALGB, ECOG and SWOG [NCT01256398] | Phase 2 | 66 participants (Actual) | Interventional | 2010-12-14 | Completed |
| A Prospective Randomize Study: Prevention of Nausea and Vomiting in Plastic Surgery [NCT02382146] | Phase 4 | 60 participants (Actual) | Interventional | 2012-04-30 | Completed |
| Effect of Antenatal Corticosteroids on Neonatal Morbidity. [NCT03446937] | | 150 participants (Actual) | Interventional | 2017-12-01 | Completed |
| Moscow-Berlin 2015 Multicenter Randomized Study for Treatment of Acute Lymphoblastic Leukemia in Children, Adolescents and Young Adults [NCT03390387] | | 4,000 participants (Anticipated) | Interventional | 2015-11-30 | Recruiting |
| Efficiency of IV Dexamethasone Compared to Placebo, Administrated After a Lower Limb Blockade is Done, on the Post Operative Pain in Children : a Controled, Randomised, Double Blind Study [NCT03618173] | Phase 3 | 80 participants (Anticipated) | Interventional | 2018-09-01 | Not yet recruiting |
| Prophylactic Paracetamol or Dexamethasone for Post-spinal Anesthesia Shivering in Patients Undergoing Non-obstetric Surgeries: a Randomized Controlled Trial [NCT03679065] | Phase 4 | 300 participants (Actual) | Interventional | 2018-03-01 | Completed |
| The Effect of Protracted Saphenous Nerve and Obturator Nerve Block Versus Saphenous Nerve Block Versus Local Infiltration Analgesia on Opioid Consumption, Pain, Block Duration of Action and Mobilization After Total Knee Arthroplasty. [NCT02067078] | Phase 4 | 75 participants (Actual) | Interventional | 2014-02-28 | Completed |
| A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-502 Compared to AzaSite Alone, Dexamethasone Alone, and Vehicle in the Treatment of Subjects With Non-Bacterial Blepharitis [NCT01408082] | Phase 3 | 917 participants (Actual) | Interventional | 2011-10-31 | Completed |
| Effect of Submucosal Cryotherapy Compared to Steroidal and Non-Steroidal Anti-Inflammatory Drugs Injection on Postoperative Endodontic Pain [NCT06090500] | | 40 participants (Anticipated) | Interventional | 2023-03-20 | Recruiting |
| A Randomized Controlled Trial of Dexamethasone for Dyspnea in Cancer Patients [NCT03367156] | Phase 2 | 135 participants (Actual) | Interventional | 2017-12-04 | Active, not recruiting |
| Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction in Elderly Patients Undergoing to General Anesthesia [NCT01332812] | Phase 4 | 300 participants (Actual) | Interventional | 2011-01-31 | Completed |
| The Compare the Effect of Peroperative Intravenous Single Dose Dexamethasone and the Addition of Dexamethasone to Femoral Nerve Block on Postoperative Analgesic Consumption Anf Patient Comfort in Unilateral Total Knee Arthroplasty Patients [NCT02090790] | Phase 4 | 60 participants (Anticipated) | Interventional | 2014-03-31 | Recruiting |
| An Evaluation of Moxidex Ophthalmic Solution for Treatment of Marginal Corneal Infiltrates [NCT00579020] | Phase 2 | 144 participants (Actual) | Interventional | 2007-12-31 | Terminated(stopped due to Management decision) |
| A Phase I Study of Oral Metronomic Dosing of Oral Cyclophosphamide With Dexamethasone for Metastatic Castration Resistant Prostate Cancer [NCT05479578] | Phase 1 | 12 participants (Anticipated) | Interventional | 2022-06-29 | Recruiting |
| Comparison Between the Analgesic Effects of Ultrasound-guided Unilateral Quadratus Lumborum Block (Lateral Approach) Versus Erector Spinae Plane Block in Patients Undergoing Unilateral Lower Abdominal Surgery [NCT05524038] | | 48 participants (Anticipated) | Interventional | 2021-01-01 | Recruiting |
| Pilot Trial Evaluating Viral Protein Production From the Combination of Reolysin and Carfilzomib in Multiple Myeloma [NCT02101944] | Phase 1 | 12 participants (Actual) | Interventional | 2014-09-25 | Active, not recruiting |
| A Phase III Randomized Trial of Blinatumomab for Newly Diagnosed BCR-ABL-Negative B Lineage Acute Lymphoblastic Leukemia in Adults [NCT02003222] | Phase 3 | 488 participants (Actual) | Interventional | 2014-05-19 | Active, not recruiting |
| Efficacy and Safety of Methylprednisolone Versus Dexamethasone in Caudal Block for Children Undergoing Hypospadias Surgical Repair: A Bi-center Randomized Controlled Study [NCT05717374] | | 80 participants (Anticipated) | Interventional | 2023-02-13 | Recruiting |
| Comparative Study of the Preoperative Efficacy of Traumeel Versus Dexamethasone in Control of Pain, Swelling and Trismus After Mandibular Third Molar Extractions [NCT03567369] | | 17 participants (Anticipated) | Interventional | 2018-04-02 | Enrolling by invitation |
| Phase II Study of Daratumumab in Combination With Azacitidine and Dexamethasone in Relapsed/Refractory Multiple Myeloma Patients Previously Treated With Daratumumab [NCT04407442] | Phase 2 | 5 participants (Actual) | Interventional | 2020-11-30 | Terminated(stopped due to Slow enrollment and change in sponsor direction) |
| A Phase I/II Study of the Combination of Venetoclax, Ponatinib and Corticosteroids in Patients With Relapsed or Refractory Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia and Lymphoid Blast Phase Chronic Myelogenous Leukemia [NCT03576547] | Phase 1/Phase 2 | 11 participants (Actual) | Interventional | 2018-06-26 | Active, not recruiting |
| Phase II Study of Combination of Hyper-CVAD and Dasatinib in Patients With Philadelphia (Ph) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) [NCT00390793] | Phase 2 | 107 participants (Actual) | Interventional | 2006-09-28 | Active, not recruiting |
| Adductor Canal Block: Single Injection vs Catheter for Pain Management of Total Knee Arthroplasty - A Randomized, Unblinded, Non-Inferiority Trial [NCT02798835] | Phase 4 | 180 participants (Actual) | Interventional | 2016-07-31 | Completed |
| Phase 1 / 2 Trial of Idasanutlin in Combination With Ixazomib and Dexamethasone in Patients With 17p Deleted, Relapsed Multiple Myeloma [NCT02633059] | Phase 1/Phase 2 | 33 participants (Actual) | Interventional | 2015-12-30 | Active, not recruiting |
| A Randomized Phase 2 Trial of Brentuximab Vedotin (SGN35, NSC# 749710), or Crizotinib (NSC#749005, Commercially Labeled) in Combination With Chemotherapy for Newly Diagnosed Patients With Anaplastic Large Cell Lymphoma (ALCL) [NCT01979536] | Phase 2 | 137 participants (Actual) | Interventional | 2013-11-13 | Active, not recruiting |
| Phase II Study of Combination of Hyper-CVAD and Ponatinib in Patients With Philadelphia (PH) Chromosome Positive and/or BCR-ABL Positive Acute Lymphoblastic Leukemia (ALL) [NCT01424982] | Phase 2 | 88 participants (Actual) | Interventional | 2011-10-05 | Active, not recruiting |
| Assessment of Rituximab Therapeutic Response Versus Conventional Treatment in the Management of Refractory Nephrotic Syndrome [NCT05553496] | Phase 2/Phase 3 | 40 participants (Anticipated) | Interventional | 2022-09-25 | Not yet recruiting |
| Olanzapine for the Prevention of Delayed Nausea and Vomiting in Patients With Gynecologic Cancers Receiving Carboplatin and Paclitaxel-based Chemotherapy and Guideline-directed Prophylactic Anti-emetics [NCT02290470] | Phase 2 | 81 participants (Anticipated) | Interventional | 2014-04-30 | Recruiting |
| Quadratus Lumborum Block (QLB) With and Without Dexamethasone: the Effect on Postoperative Pain and Recovery After Laparoscopic Nephrectomy [NCT03339284] | Phase 4 | 90 participants (Anticipated) | Interventional | 2017-12-04 | Recruiting |
| Treatment of Renal Failure Due to Myeloma Cast Nephropathy: Comparison of Two Different Chemotherapy Regimens and Evaluation of Optimized Removal of Monoclonal Immunoglobulin Light Chains Using a High Permeability Hemodialysis Membrane. [NCT01208818] | Phase 3 | 284 participants (Anticipated) | Interventional | 2011-06-30 | Completed |
| The Effect of Dexamethasone Implant on Retinal Nerve Fiber and Optic Disc Morphology in Patients With Diabetic Maculopathy [NCT03927118] | | 43 participants (Actual) | Observational | 2018-02-01 | Completed |
| A Multi-Center, Randomized, Double-Masked Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, I [NCT00945802] | Phase 3 | 5 participants (Actual) | Interventional | 2009-07-31 | Terminated |
| Phase 2 Clinical Trial for Comprehensive Treatment Program for Patients With Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN): Tagraxofusp (SL-401) in Combination With HCVAD/Mini-CVD and VENETOCLAX [NCT04216524] | Phase 2 | 40 participants (Anticipated) | Interventional | 2020-05-29 | Recruiting |
| Ketorolac Plus Tobramycin/Dexamethasone vs. Tobramycin/Dexamethasone After Uneventful Phacoemulsification Surgery [NCT01103401] | | 145 participants (Actual) | Interventional | 2009-10-31 | Completed |
| Temsirolimus Alone or Paired With Dexamethasone Delivered to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization [NCT03942601] | Phase 2 | 60 participants (Anticipated) | Interventional | 2019-10-01 | Recruiting |
| A Phase III Randomized Trial Investigating Bortezomib (NSC# 681239) on a Modified Augmented BFM (ABFM) Backbone in Newly Diagnosed T-Lymphoblastic Leukemia (T-ALL) and T-Lymphoblastic Lymphoma (T-LLy) [NCT02112916] | Phase 3 | 847 participants (Actual) | Interventional | 2014-10-04 | Active, not recruiting |
| Safety and Imaging of Post-Operative Low Dose Versus Standard Dose Dexamethasone in Patients With Primary or Metastatic Brain Tumors: a Randomized, Double-blinded Feasibility Study. [NCT05139043] | Phase 2 | 24 participants (Anticipated) | Interventional | 2022-04-09 | Recruiting |
| Effect of Lidocaine/Dexamethasone on the Success of IANB in Patients With Irreversible Pulpitis [NCT03531970] | Phase 2/Phase 3 | 100 participants (Actual) | Interventional | 2016-08-01 | Completed |
| Phase II Study of SOM230 LAR in Combination With Bortezomib and Dexamethasone in Patients With Refractory or Relapsed Multiple Myeloma [NCT01329289] | Phase 2 | 0 participants (Actual) | Interventional | 2011-12-31 | Withdrawn(stopped due to Clinical trial being transferred to Columbia University with the Investigator.) |
| International Phase 3 Trial in Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) Testing Imatinib in Combination With Two Different Cytotoxic Chemotherapy Backbones [NCT03007147] | Phase 3 | 475 participants (Anticipated) | Interventional | 2017-08-08 | Recruiting |
| Multicenter Non-interventional Study to Investigate Drug Utilization of Pomalidomide in Clinical Practice for the Treatment of Relapsed/Refractory Multiple Myeloma (rrMM) [NCT02555839] | | 150 participants (Anticipated) | Observational | 2015-02-20 | Active, not recruiting |
| A Randomized Phase III Trial of CC-5013 (Lenalidomide, NSC-703813) and Low Dose Dexamethasone (LLD) Versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients With Previously Untreated Multiple Myelom [NCT00644228] | Phase 3 | 525 participants (Actual) | Interventional | 2008-04-01 | Active, not recruiting |
| Intensified Methotrexate, Nelarabine (Compound 506U78) and Augmented BFM Therapy for Children and Young Adults With Newly Diagnosed T-cell Acute Lymphoblastic Leukemia (ALL) or T-cell Lymphoblastic Lymphoma [NCT00408005] | Phase 3 | 1,895 participants (Actual) | Interventional | 2007-01-22 | Active, not recruiting |
| A Randomized Phase III Study of CC-5013 Plus Dexamethasone Versus CC-5013 Plus Low Dose Dexamethasone in Multiple Myeloma With Thalidomide Plus Dexamethasone Salvage Therapy for Non-Responders [NCT00098475] | Phase 3 | 452 participants (Actual) | Interventional | 2004-11-03 | Active, not recruiting |
| Prevention of Cisplatin-Induced Hearing Loss by Intratympanic Dexamethasone Treatment. [NCT01372904] | Phase 4 | 30 participants (Actual) | Interventional | 2011-06-30 | Completed |
| 4-drug Nerve Block Versus Plain Local Anesthetic for Knee and Hip Arthroplasty Analgesia in Veterans [NCT02891798] | Phase 3 | 98 participants (Actual) | Interventional | 2016-10-31 | Completed |
| High Risk B-Precursor Acute Lymphoblastic Leukemia (ALL) [NCT00075725] | Phase 3 | 3,154 participants (Actual) | Interventional | 2003-12-29 | Completed |
| A Phase 3, Randomized, Double-blind Study of Siltuximab (Anti-IL-6 Monoclonal Antibody) or Placebo in Combination With VELCADE and Dexamethasone for the Treatment of Subjects With Relapsed or Refractory Multiple Myeloma [NCT01266811] | Phase 3 | 0 participants (Actual) | Interventional | 2011-07-31 | Withdrawn(stopped due to Study canceled based on results of different study with similar hypothesis, investigational agent, & patient) |
| A Phase III Groupwide Study of Dose-Intensive Response-Based Chemotherapy and Radiation Therapy for Children and Adolescents With Newly Diagnosed Intermediate Risk Hodgkin Disease [NCT00025259] | Phase 3 | 1,734 participants (Actual) | Interventional | 2002-09-30 | Completed |
| Comparison of Post-operative Analgesic Effects of Two Doses of Dexamethasone Added to Bupivacaine in Ultrasound-guided Transversusabdominis Plane (TAP) Block for Inguinal Hernia Repair [NCT03863977] | Phase 2/Phase 3 | 90 participants (Actual) | Interventional | 2019-03-15 | Completed |
| Phase 2 Trial of Pomalidomide, Ixazomib and Dexamethasone in Patients With Multiple Myeloma With Extramedullary Disease or Plasma Cell Leukemia [NCT02547662] | Phase 2 | 17 participants (Actual) | Interventional | 2015-12-24 | Completed |
| Analgesic Efficacy of Ultrasound-guided Greater Occipital Nerve Block in Patients of Chronic Migraine [NCT05679765] | Phase 4 | 50 participants (Actual) | Interventional | 2022-04-01 | Completed |
| Phase II Study of Ibrutinib With or Without Bortezomib and Dexamethasone for the Treatment of Patients With Relapsed/Refractory Immunoglobulin Light Chain Amyloidosis [NCT03130348] | Phase 2 | 0 participants (Actual) | Interventional | 2018-03-15 | Withdrawn(stopped due to Study was dropped at site before participation) |
| The Combination of Lenalidomide and Dexamethasone With or Without Intensification by High-dose Melphalan in the Treatment of Multiple Myeloma [NCT01090089] | Phase 3 | 348 participants (Actual) | Interventional | 2010-03-01 | Completed |
| [NCT01239719] | Phase 3 | 96 participants (Anticipated) | Interventional | 2011-03-31 | Not yet recruiting |
| Evaluation of Corticosteroid as Modulators of Humeral and Cellular Immune Response in Open Heart Surgery in Egyptian Population [NCT03876041] | Phase 4 | 60 participants (Actual) | Interventional | 2019-09-01 | Completed |
| Comparative Evaluation of the Effect of a Prophylactic Intraligamentary Injection of Dexamethasone and Piroxicam on Postoperative Pain in Teeth With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial [NCT03745105] | | 42 participants (Anticipated) | Interventional | 2018-12-25 | Not yet recruiting |
| Myeloma-Developing Regimens Using Genomics (MyDRUG) (Genomics Guided Multi-arm Trial of Targeted Agents Alone or in Combination With a Backbone Regimen) [NCT03732703] | Phase 1/Phase 2 | 228 participants (Anticipated) | Interventional | 2019-04-01 | Recruiting |
| Thalidomide Plus Dexamethasone as Maintenance Therapy After Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma: a Multicenter Phase 3 Randomized Trial [NCT01296503] | Phase 3 | 213 participants (Actual) | Interventional | 2003-10-31 | Completed |
| Phase 3 Study, Randomized, Double-blind, Parallel to Evaluate Ketoconazole and Betamethasone Dipropionate(Candicort®) Compared to Clotrimazole and Dexamethasone Acetate(Baycuten N®) in Relief of Fungal Infections/Dermatophytosis Symptoms. [NCT02582177] | Phase 3 | 125 participants (Actual) | Interventional | 2019-06-11 | Completed |
| A Phase II Study of Induction Systemic mFOLFIRINOX Followed by Hepatic Arterial Infusion of Floxuridine and Dexamethasone Given Concurrently With Systemic mFOLFIRI as a First-Line Therapy in Patients With Unresectable Liver-Dominant Intrahepatic Cholangio [NCT04251715] | Phase 2 | 30 participants (Anticipated) | Interventional | 2021-04-28 | Recruiting |
| Efficacy of Dexamethasone Treatment for Patients With ARDS Caused by COVID-19 [NCT04325061] | Phase 4 | 19 participants (Actual) | Interventional | 2020-04-03 | Terminated(stopped due to Lack of enrollment) |
| Trans-foraminal Lumbar Epidural Injection of Dexmedetomidine Against Magnesium Sulfate When Combined With Dexamethasone in Uni-lateral Lower Limb Radicular Pain. Multi-centeric Comparative Study [NCT05271721] | | 90 participants (Anticipated) | Interventional | 2022-03-01 | Recruiting |
| A 6-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Safety and Efficacy Study of the Potential Inhibitory Effects on the Hypothalamic-Pituitary-Adrenal Axis of Ciclesonide HFA Nasal Aerosol and Ciclesonide Aqueous Nasal Spray in Subject [NCT01033825] | Phase 3 | 310 participants (Actual) | Interventional | 2010-01-31 | Completed |
| An Endocrinologically and Pharmacologically Directed Trial of Ketoconazole and Corticosteroids in Castration Resistant Prostate Cancer [NCT01036594] | Phase 2 | 32 participants (Actual) | Interventional | 2009-12-11 | Completed |
| Phase 1/2 Study of Daratumumab, Bortezomib, Dexamethasone With or Without Venetoclax in Relapsed/Refractory Multiple Myeloma With Assessment for t(11;14) Status [NCT03701321] | Phase 1/Phase 2 | 0 participants (Actual) | Interventional | 2019-01-25 | Withdrawn(stopped due to Drug supply issues) |
| Postpartum Dexamethasone for Women With Class I HELLP Syndrome: a Double-blind, Placebo-controled, Randomized Clinical Trial [NCT00711841] | Phase 4 | 400 participants (Anticipated) | Interventional | 2011-07-31 | Terminated(stopped due to The speed of recruitment was slower than anticipated.) |
| Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery [NCT02665533] | | 18 participants (Actual) | Interventional | 2016-01-31 | Completed |
| Late Onset Postoperative Nausea and Vomiting Following Strabismus Surgery in Pediatric.What Combination is Better [NCT00918190] | | 75 participants (Anticipated) | Interventional | 2009-06-30 | Completed |
| The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study. [NCT04084912] | Phase 3 | 86 participants (Anticipated) | Interventional | 2020-01-01 | Not yet recruiting |
| A Phase II Study Evaluating Loncastuximab Tesirine in Patients With Previously Treated Waldenström Macroglobulinemia [NCT05190705] | Phase 2 | 36 participants (Anticipated) | Interventional | 2022-02-17 | Recruiting |
| Dexamethasone for the Treatment of Established Postoperative Nausea and Vomiting - a Randomised, Placebo-controlled, Dose-finding Study [NCT01975727] | Phase 2 | 256 participants (Actual) | Interventional | 2012-09-03 | Terminated(stopped due to Study was halted prematurely for futility after an intermediate analysis) |
| A Phase III Study for Patients Relapsing or Progressing After Autologous Transplantation on Total Therapy 2 (TT2, UARK 98-026): Bortezomib, Thalidomide and Dexamethasone Versus Bortezomib, Melphalan, and Dexamethasone [NCT00573391] | Phase 3 | 5 participants (Actual) | Interventional | 2006-08-31 | Terminated(stopped due to low accrual) |
| Comparison of the Effects of Different Time of Intravenous Dexamethasone on Brachial Plexus Block: a Randomized Control Study [NCT04714112] | Phase 4 | 180 participants (Actual) | Interventional | 2021-01-10 | Completed |
| The Efficacy of Intravenous Dexamethasone on the Duration of Analgesia of Ultrasound Guided Axillary Brachial Plexus Block in Pediatric Patients Undergoing Below Elbow Orthopaedic Surgeries: A Randomized Control Trial [NCT05466500] | | 60 participants (Anticipated) | Interventional | 2022-07-26 | Recruiting |
| A Phase III Clinical Study Evaluating the Efficacy Of FST-201 Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa [NCT00961675] | Phase 3 | 70 participants (Actual) | Interventional | 2009-08-31 | Completed |
| A Prospective, Multi-Center, Randomized, Double-Masked, Safety, Tolerability and Efficacy Study of Four Iontophoretic Doses of Dexamethasone Phosphate Ophthalmic Solution in Patients With Non-Infectious Anterior Segment Uveitis [NCT00694135] | Phase 2 | 40 participants (Actual) | Interventional | 2008-06-30 | Completed |
| The Effect of Dexamethasone Used Together With Low Volume Ropivacaine in a Single Shot Interscalene Block on the Pain Free Time Experienced by the Patient [NCT02178449] | Phase 4 | 109 participants (Anticipated) | Interventional | 2014-03-31 | Recruiting |
| A Multicenter Randomized Trial to Evaluate the Efficacy and Safety of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting in Patients Undergoing Vitrectomy Under Local Anesthesia [NCT02386059] | Phase 4 | 1,200 participants (Anticipated) | Interventional | 2015-03-31 | Not yet recruiting |
| Risk-Stratified Randomized Phase III Testing of Blinatumomab (NSC#765986) in First Relapse of Childhood B-Lymphoblastic Leukemia (B-ALL) [NCT02101853] | Phase 3 | 669 participants (Actual) | Interventional | 2014-12-17 | Active, not recruiting |
| A Randomized Phase I/II Study of Optimal Induction Therapy of Bortezomib, Dexamethasone and Lenalidomide With or Without Elotuzumab (NSC-764479) for Newly Diagnosed High Risk Multiple Myeloma (HRMM) [NCT01668719] | Phase 1/Phase 2 | 142 participants (Actual) | Interventional | 2012-11-30 | Active, not recruiting |
| Opioid Sparing Analgesic Strategies for Enhanced Recovery After Total Knee Arthroplasty [NCT03954379] | Phase 4 | 78 participants (Actual) | Interventional | 2019-10-24 | Completed |
| Open Label, Non Controlled, Non Randomized, Interventional Study to Evaluate the Response Rate After Induction Therapy With DocEtaxel and CIsplatin in Unresectable Locally Advanced Squamous Cell Carcinoma of heaD and nEck [NCT02061631] | Phase 2 | 35 participants (Actual) | Interventional | 2014-05-31 | Completed |
| Role of Hyperinsulinemia in NAFLD: Dexamethasone-Pancreatic Clamp Pilot & Feasibility Study [NCT06126354] | Phase 1 | 16 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
| The Effectiveness of Cervical Transforaminal Epidural Steroid Injection for the Treatment of Cervical Radicular Pain: A Prospective Cohort Study. [NCT04544683] | Phase 4 | 29 participants (Actual) | Interventional | 2018-10-23 | Active, not recruiting |
| Phase II Study of Targeting CD28 in Multiple Myeloma With Abatacept (CTLA4-Ig) to Overcome Resistance to Chemotherapy [NCT03457142] | Phase 2 | 15 participants (Actual) | Interventional | 2018-09-11 | Active, not recruiting |
| Analgesic Duration of Interscalene Block After Outpatient Arthroscopic Shoulder Surgery With Intravenous Dexamethasone, Dexmedetomidine or Their Combination: A Randomized Controlled Trial [NCT03270033] | Phase 4 | 198 participants (Actual) | Interventional | 2017-09-18 | Completed |
| A Phase1 Study at Stanford of Palbociclib in Combination With Chemotherapy in Pediatric Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (RELPALL2) [NCT04996160] | Phase 1 | 22 participants (Anticipated) | Interventional | 2021-07-09 | Recruiting |
| A Phase 1/2 Trial of ASP7487 OSI-906)in Combination With Bortezomib and Dexamethasone for the Treatment of Relapsed or Relapsed/Refractory Multiple Myeloma [NCT01672736] | Phase 1/Phase 2 | 19 participants (Actual) | Interventional | 2012-09-30 | Terminated(stopped due to The Sponsor decided to stop further manufacture the study drug 'Linsitinib' in Nov 2015.) |
| A Comparative Effectiveness Randomised Placebo Controlled Pilot Trial of the Management of Acute Lumbar Radicular Pain: Evaluate Route Versus Pharmacology of Intervention, and Feasibility in Public Hospital and Community Practice Settings. [NCT03240783] | Phase 2 | 60 participants (Anticipated) | Interventional | 2017-07-08 | Recruiting |
| Randomized Clinical Trial to Evaluate the Efficacy of Different Treatments in Patients With COVID-19 [NCT04890626] | Phase 3 | 2,193 participants (Anticipated) | Interventional | 2020-04-04 | Recruiting |
| Treatment of Newly Diagnosed Standard Risk Acute Lymphoblastic Leukemia in [NCT06099366] | Phase 2 | 116 participants (Anticipated) | Interventional | 2024-01-15 | Not yet recruiting |
| "A Phase III Randomized Trial for Newly Diagnosed Multiple Myeloma (NDMM) Patients Considered Frail or in a Subset of Intermediate Fit Comparing Upfront Three-Drug Induction Regimens Followed by Double or Single-Agent Maintenance" [NCT05561387] | Phase 3 | 510 participants (Anticipated) | Interventional | 2023-10-12 | Recruiting |
| A Phase Ib/II Open-Label Study of APG-2575 in Combination With Novel Therapeutic Regimens in Subjects With Relapsed or Refractory Multiple Myeloma and Immunoglobin Light Chain Amyloidosis [NCT04942067] | Phase 1/Phase 2 | 108 participants (Anticipated) | Interventional | 2021-12-23 | Recruiting |
| A Phase 3 Double-masked, Randomized, Multicenter Study of the Efficacy and Safety of OCS 01 Eye Drops in Subjects With Diabetic Macular Edema [NCT06172257] | Phase 3 | 350 participants (Anticipated) | Interventional | 2023-12-31 | Not yet recruiting |
| Dexamethasone Solution and Dexamethasone in Mucolox™ for the Treatment of Oral Inflammatory Ulcerative Diseases [NCT04540133] | Phase 2 | 29 participants (Actual) | Interventional | 2020-12-26 | Completed |
| Standard Risk B-precursor Acute Lymphoblastic Leukemia (ALL) [NCT00103285] | Phase 3 | 5,377 participants (Actual) | Interventional | 2005-04-11 | Completed |
| Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery [NCT02416869] | Phase 4 | 60 participants (Actual) | Interventional | 2014-01-31 | Completed |
| A Combination Therapy for Cancer-Related Fatigue in Advanced Cancer Patients [NCT03583255] | Phase 2/Phase 3 | 99 participants (Actual) | Interventional | 2018-06-29 | Active, not recruiting |
| Single Dose Dexamethasone is as Effective as Two Doses in Mild to Moderate Pediatric Asthma Exacerbations in the Emergency Department [NCT02192827] | Phase 3 | 318 participants (Actual) | Interventional | 2015-04-30 | Completed |
| Effects of Physical Activity Plus Short Course of Dexamethasone for Cancer-Related Fatigue in Advanced Cancer [NCT02491632] | Phase 2/Phase 3 | 90 participants (Actual) | Interventional | 2015-08-13 | Active, not recruiting |
| A Multicenter Phase II Trial of Bortezomib (Velcade), Melphalan, and Dexamethasone (V-MD) in Patients With Symptomatic AL-Amyloidosis or Light Chain Deposition Disease [NCT00520767] | Phase 2 | 35 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Phase III Study of Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone (Isa-KRd) Versus Carfilzomib-Lenalidomide-Dexamethasone (KRd) in Newly Diagnosed Multiple Myeloma Patients Eligible for Autologous Stem Cell Transplantation (IsKia TRIAL [NCT04483739] | Phase 3 | 302 participants (Actual) | Interventional | 2020-09-25 | Active, not recruiting |
| Comparison of Perioperative Intravenous vs Periarticular Dexamethasone vs no Steroid Supplementation in Terms of Post-operative Pain, Function, Nausea, Hospitalization Length, and Risk of Complications in Patients Undergoing Primary Total Knee Arthroplast [NCT04432012] | Phase 4 | 159 participants (Anticipated) | Interventional | 2020-07-01 | Recruiting |
| Dexamethasone for Acute Migraine. A Randomized Dose-comparison Study [NCT04112823] | Phase 4 | 209 participants (Actual) | Interventional | 2019-12-01 | Completed |
| A Multicenter, Open Label, Randomized Phase II Study Comparing Daratumumab Combined With Bortezomib-Cyclophosphamide-dexamethasone (Dara-VCd) Versus the Association of Bortezomib-Thalidomide-dexamethasone (VTd) as Pre Transplant Induction and Post Transpl [NCT03896737] | Phase 2 | 401 participants (Actual) | Interventional | 2019-04-16 | Active, not recruiting |
| A Multi-central Perspective Randomized Controlled Study Evaluating the Efficacy and Safety of Aprepitant in Autologous Hematopoietic Stem Cell Transplantation [NCT02576327] | Phase 4 | 130 participants (Anticipated) | Interventional | 2015-10-31 | Active, not recruiting |
| Intraoperative Autonomic Neural Blockade (ANB) Comparison Between Different Local Anesthetic Combinations. A Randomized Clinical Trial Protocol [NCT06137924] | Phase 3 | 150 participants (Anticipated) | Interventional | 2023-12-02 | Not yet recruiting |
| A Phase 1 Clinical Study to Investigate the Safety and Pharmacokinetics of MK-5684 in China Participants With Metastatic Castration-Resistant Prostate Cancer [NCT06136598] | Phase 1 | 14 participants (Anticipated) | Interventional | 2023-12-25 | Not yet recruiting |
| Safety and Efficacy of Elotuzumab, CC-92480, and Dexamethasone in Relapsed/Refractory Myeloma After CD38- and BCMA-Targeted Therapies [NCT05981209] | Phase 1 | 27 participants (Anticipated) | Interventional | 2023-12-31 | Recruiting |
| A Phase 1b/2 Study of Standard Doses of Bortezomib and Pembrolizumab ± Reovirus (Pelareorep) Combination Therapy in Patients With Relapsed Multiple Myeloma (AMBUSH Study) [NCT05514990] | Phase 1/Phase 2 | 42 participants (Anticipated) | Interventional | 2022-10-07 | Recruiting |
| Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Blinatumomab With or Without Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia [NCT02877303] | Phase 2 | 80 participants (Anticipated) | Interventional | 2016-11-01 | Recruiting |
| Total Therapy Study XVI for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia [NCT00549848] | Phase 3 | 600 participants (Actual) | Interventional | 2007-10-29 | Completed |
| Phase II Open Lable Clinical Study Efficacy and Safety of the Holistic Treatment for Young Patients With High-Risk Multiple Myeloma [NCT04008888] | | 50 participants (Anticipated) | Interventional | 2018-01-05 | Recruiting |
| A Phase I/II Trial of Lenalidomide Combined With Cyclophosphamide and Intermediate Dose Dexamethasone in Patients With Primary (AL) Systemic Amyloidosis [NCT00981708] | Phase 1/Phase 2 | 37 participants (Actual) | Interventional | 2008-02-29 | Completed |
| The Official Title is A Multi-center, Randomized, Parallel-group, Double-blind, Placebo Controlled Study of CC-5013 Plus Dexamethasone Versus Dexamethasone Alone in Previously Treated Subjects With Multiple Myeloma. [NCT00424047] | Phase 3 | 351 participants (Actual) | Interventional | 2003-01-01 | Completed |
| Effect of Systematic Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery [NCT05887778] | Phase 4 | 90 participants (Anticipated) | Interventional | 2023-09-18 | Recruiting |
| Effect of Systematic Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery [NCT05887765] | Phase 4 | 90 participants (Anticipated) | Interventional | 2023-10-19 | Enrolling by invitation |
| Dexmedetomidine Versus Dexamethasone as Adjuvants to Bupivacaine for Ultrasound-guided Intermediate Cervical Plexus Block in Patients Undergoing Thyroidectomy [NCT05793060] | Phase 4 | 60 participants (Anticipated) | Interventional | 2022-04-15 | Recruiting |
| Analysis of the Effect of Intravitreal Dexamethasone Injection on Diabetic Macular Edema After Cataract Surgery (IDDMECS) [NCT01030601] | Phase 2 | 48 participants (Anticipated) | Interventional | 2010-01-31 | Completed |
| Phase 2 Trial of Lenalidomide (Revlimid)-Dexamethasone + Rituximab in Recurrent Small B-Cell Non-Hodgkin Lymphomas (NHL) Resistant to Rituximab [NCT00783367] | Phase 2 | 50 participants (Actual) | Interventional | 2008-07-31 | Completed |
| A Pilot Study of Lenalidomide, Melphalan and Dexamethasone in AL Amyloidosis [NCT00890552] | | 25 participants (Actual) | Interventional | 2009-04-30 | Completed |
| Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Between Lenticule Extraction and Small-Incision Lenticule Extraction [NCT02540785] | | 41 participants (Actual) | Interventional | 2014-04-30 | Completed |
| The Combination of Oral All-trans Retinoic Acid and High-dose Dexamethasone vs High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia: A Multicenter, Randomized, Open-label Trial [NCT04217148] | Phase 2 | 132 participants (Actual) | Interventional | 2020-01-01 | Completed |
| A Randomized Phase II Study of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel Versus Standard of Care in Patients With Previously - Treated NFE2L2 or KEAP1-Positive Stage IV or Recurrent Squamous Cell Lung Cancer (ECOG-ACRIN LUNG-MAP Sub-Study) [NCT04267913] | Phase 2 | 0 participants (Actual) | Interventional | 2020-09-05 | Withdrawn(stopped due to The pharmaceutical company sold the compound and pulled out.) |
| A Randomized, Double-blind, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of Early Administration of Dexamethasone in High-risk Sepsis [NCT05136560] | Phase 1/Phase 2 | 102 participants (Anticipated) | Interventional | 2021-01-15 | Recruiting |
| A Phase 2 Evaluation of Daratumumab-Based Treatment in Newly Diagnosed Multiple Myeloma Patients With Renal Insufficiency [NCT04352205] | Phase 2 | 25 participants (Anticipated) | Interventional | 2020-05-07 | Recruiting |
| Dexamethasone Added to Levobupivacaine in Ultrasound-guided Tranversus Abdominis Plain Block Increased the Duration of Postoperative Analgesia After Laparoscopic Cholecystectomy [NCT02783144] | Phase 3 | 120 participants (Actual) | Interventional | 2017-06-28 | Completed |
| Effect of Perineural Versus Intravenous Dexamethasone On Analgesic Efficacy of Transverse Abdominis Plane Block With Levobupivacaine In Laparoscopic Gynaecological Procedures: A Randomized, Double-Blind Study [NCT02838719] | | 40 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Randomized Controlled Trial Assessing the Effect of Intraoperative Dexamethasone in the Management of Postoperative Analgesia and Stiffness After Distal Radius Fixation [NCT04889547] | Early Phase 1 | 70 participants (Actual) | Interventional | 2021-07-10 | Completed |
| Comparison Between Xylocaine Gel as Endotracheal Cuff Lubricant Versus Dexamethasone 8 mg Intravenously or Both for Sore Throat Prevention Following Intubation: Interventional Study [NCT02682134] | Phase 4 | 300 participants (Actual) | Interventional | 2015-11-30 | Completed |
| A Phase III Study of Risk Directed Therapy for Infants With Acute Lymphoblastic Leukemia (ALL): Randomization of Highest Risk Infants to Intensive Chemotherapy +/- FLT3 Inhibition (CEP-701, Lestaurtinib; NSC#617807) [NCT00557193] | Phase 3 | 218 participants (Actual) | Interventional | 2008-01-15 | Active, not recruiting |
| Effects of Holy-Comod and Tears Naturale Forte on Ocular Surface and Tear Inflammatory Mediators in Patients After Phaco+IOL [NCT02817191] | | 80 participants (Anticipated) | Interventional | 2016-06-30 | Recruiting |
| A Phase Ib Feasibility Study of Personalized Kinase Inhibitor Therapy Combined With Induction in Acute Leukemias Who Exhibit In Vitro Kinase Inhibitor Sensitivity [NCT02779283] | Phase 1 | 7 participants (Actual) | Interventional | 2016-01-13 | Completed |
| A Prospective Phase II Trial of Modified MRC UKALL Ⅻ/ECOG E2993 Regimen in the Treatment of Low Risk Philadelphia Chromosome Negative Acute Lymphoblastic Leukemia for Young Adults [NCT02660762] | Phase 2 | 100 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
| Combination of Dexamethasone and Bupivacaine Versus Bupivacaine Alone in Combined Femoral and Sciatic Nerve Block for Intraoperative and Postoperative Analgesia in Patients Undergoing Lower Limb Vascular Surgeries [NCT02576782] | Phase 4 | 63 participants (Actual) | Interventional | 2013-06-30 | Completed |
| Phase II Study of Carfilzomib-cyclophosphamide-dexamethasone and High-dose Melphalan (HDT) Followed by Randomization Between Observation or Maintenance With Carfilzomib and Dexamethasone in Patients With Relapsed Multiple Myeloma After HDT [NCT02572492] | Phase 2 | 200 participants (Actual) | Interventional | 2015-01-31 | Active, not recruiting |
| Does the Addition of Epinephrine to Bilateral Ultrasound Guided Pterygopalatine Ganglion Block Reduce Bleeding During Functional Endoscopic Sinus Surgery (FESS)? A Pilot Study [NCT03970655] | Phase 1/Phase 2 | 80 participants (Anticipated) | Interventional | 2019-09-25 | Recruiting |
| A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study Evaluating AVM0703 in Patients With Acute Respiratory Distress Syndrome [NCT04366115] | Phase 1 | 16 participants (Anticipated) | Interventional | 2022-12-01 | Not yet recruiting |
| Study of Daratumumab in Combination With Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD) in the First Line Treatment of Transplant Eligible Subjects With Newly Diagnosed Multiple Myeloma [NCT02541383] | Phase 3 | 1,085 participants (Actual) | Interventional | 2015-09-30 | Active, not recruiting |
| A Phase 3 Trial Investigating Blinatumomab (NSC# 765986) in Combination With Chemotherapy in Patients With Newly Diagnosed Standard Risk or Down Syndrome B-Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients With Localized B-Lymphoblastic Lymphom [NCT03914625] | Phase 3 | 6,720 participants (Anticipated) | Interventional | 2019-07-03 | Recruiting |
| Phase I Clinical Trial of Bcl2 Inhibitor Venetoclax in Combination With Lenalidomide and Dexamethasone (Ven-Rd), Daratumumab and Dexamethasone (Ven-Dd), or Daratumumab-Lenalidomide-Dexamethasone (Ven-DRd) in t(11;14) Multiple Myeloma [NCT06042725] | Phase 1 | 100 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
| A Study of Single Dose Intravenous Casopitant in Combination With Ondansetron and Dexamethasone for the Prevention of Cisplatin-Induced Nausea and Vomiting [NCT00891761] | Phase 3 | 0 participants (Actual) | Interventional | 2009-09-30 | Withdrawn(stopped due to This study has been cancelled prior to enrollment.) |
| A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP) [NCT00909077] | Phase 3 | 155 participants (Actual) | Interventional | 2004-08-31 | Completed |
| Comparison of Ramosetron, Aprepitant, and Dexamethasone (RAD) With Palonosetron, Aprepitant, and Dexamethasone (PAD) for Prevention of Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy [NCT02532634] | Phase 4 | 292 participants (Actual) | Interventional | 2015-08-19 | Completed |
| The Effects of Glucocorticoids on Mortality and Renal Function in Patients With Acute Decompensated Heart Failure [NCT00953303] | Phase 2/Phase 3 | 102 participants (Actual) | Interventional | 2009-01-31 | Completed |
| Maintenance Therapy With Lenalidomide, Dexamethasone and Clarithromycin (Biaxin) Following Autologous/Syngeneic Transplant for Multiple Myeloma [NCT00445692] | Phase 2 | 32 participants (Actual) | Interventional | 2007-01-10 | Completed |
| A Phase I/II Double-Blinded Randomized Prospective Study of Sterile Amniotic Fluid Filtrate Epidural Injection for the Treatment of Lumbosacral Radicular Pain Due to Spinal Stenosis: Improving Safety and Outcomes in the Treatment of Pain and Disability Re [NCT04537026] | Phase 1/Phase 2 | 112 participants (Anticipated) | Interventional | 2021-06-16 | Recruiting |
| Adjunctive Dexamethasone for Cerebral Toxoplasmosis: a Double-blinded Randomized Controlled Trial [NCT04341155] | Phase 2 | 138 participants (Anticipated) | Interventional | 2021-04-16 | Recruiting |
| Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Post Operative Inflammation in Patients Having LASIK Surgery [NCT00330824] | | 64 participants (Actual) | Interventional | 2006-04-30 | Completed |
| A Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Axillary Blocks [NCT02629835] | Phase 2/Phase 3 | 150 participants (Actual) | Interventional | 2016-01-31 | Completed |
| A Phase 1b/2, Multicenter, Open-label, Dose-escalation Study of Elotuzumab (Humanized Anti-CS1 Monoclonal IgG1 Antibody) in Combination With Lenalidomide and Dexamethasone in Subjects With Relapsed Multiple Myeloma [NCT00742560] | Phase 2 | 101 participants (Actual) | Interventional | 2008-08-31 | Completed |
| Multicenter, Randomized, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral BIBF 1120 Plus Standard Pemetrexed Therapy Compared to Placebo Plus Standard Pemetrexed Therapy in Patients With Stage IIIB/IV or Recurrent Non Small Cel [NCT00806819] | Phase 3 | 718 participants (Actual) | Interventional | 2008-12-31 | Completed |
| A Phase III Randomized, Controlled, Multicenter, Open-label Study of ATG-010, Bortezomib, and Dexamethasone (SVd) Versus Bortezomib and Dexamethasone (Vd) in Patients With Relapsed or Refractory Multiple Myeloma (RRMM) [NCT04939142] | Phase 3 | 150 participants (Anticipated) | Interventional | 2021-07-12 | Active, not recruiting |
| Phase I Clinical Trial of Venetoclax (ABT-199) in Combination With Ixazomib and Dexamethasone for Patients With Relapsed Multiple Myeloma [NCT03399539] | Phase 1 | 7 participants (Actual) | Interventional | 2018-05-02 | Active, not recruiting |
| A Phase II Clinical Trial for Untreated Patients With Multiple Myeloma Eligible for Stem Cell Transplant: Lenalidomide (Revlimid®) Plus Low-dose Dexamethasone (Ld x 4 Cycles) Then Stem Cell Collection Followed by Randomization to Continued Ld or Stem Cell [NCT00807599] | Phase 2 | 67 participants (Actual) | Interventional | 2008-12-10 | Completed |
| Effect of Laparoscopic-Guided Transversus Abdominus Plane (TAP) Block on Opioid Consumption Using Dual-Adjunct Therapy With Dexmedetomidine and Dexamethasone Versus Liposomal Bupivacaine (Exparel®) Following Minimally Invasive Colorectal Surgery: A Single [NCT05216055] | Phase 2 | 0 participants (Actual) | Interventional | 2022-04-19 | Withdrawn(stopped due to No Accrual. PI left Institution) |
| Doxorubicin Hydrochloride Liposome vs Doxorubicin Combined With Bortizomib and Dexamethasone to Treat Initially Diagnosed Multiple Myeloma: A Randomized Prospective Clinical Study [NCT02577783] | Phase 4 | 64 participants (Anticipated) | Interventional | 2015-10-31 | Active, not recruiting |
| [NCT02588196] | Phase 4 | 200 participants (Anticipated) | Interventional | 2015-11-30 | Not yet recruiting |
| Effect of Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery [NCT06086392] | Phase 4 | 90 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
| A Comparison of Combination Antiemetic Regimen for Prevention of PONV in Breast Surgery Patients [NCT00738621] | Phase 4 | 100 participants (Actual) | Interventional | 2008-07-31 | Completed |
| Phase I/II Trial of Ibrutinib, Dexamethasone, and Lenalidomide as Initial Therapy for Transplant Ineligible Multiple Myeloma Patients [NCT03015792] | Phase 1/Phase 2 | 18 participants (Actual) | Interventional | 2017-03-10 | Terminated(stopped due to Per CS0139535 -submitter stated we can update status to Admin complete- low accrual reasoning) |
| Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study [NCT02666443] | | 306 participants (Anticipated) | Interventional | 2016-09-30 | Recruiting |
| Phase I/II Study of Lenalidomide (Revlimid), Thalidomide, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma [NCT00966693] | Phase 1/Phase 2 | 77 participants (Actual) | Interventional | 2009-08-25 | Completed |
| Effect of Topical Dexamethasone on Histologic Response of Human Dental Pulp [NCT02574468] | Phase 4 | 10 participants (Actual) | Interventional | 2013-01-31 | Completed |
| An Evaluation of the Safety and Efficacy of the Administration of a Fixed Combination of Moxifloxacin 0.5% and Dexamethasone 0.1% Eye Drops Compared With the Individual Administration of Moxifloxacin 0.5% and Dexamethasone 0.1% in the Treatment of Bacteri [NCT00732446] | Phase 3 | 100 participants (Anticipated) | Interventional | 2008-08-31 | Completed |
| Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered Via Episcleral Reservoir for Treatment of Macular Edema & Inflammatory Disorders of the Eye Posterior Pole Including Sclera, Choroid, Retina or Vitreous [NCT04120311] | Phase 1 | 2 participants (Actual) | Interventional | 2019-09-01 | Active, not recruiting |
| A Phase I Study of Sequestered Transscleral, Controlled-Release Dexamethasone Delivered From an Episcleral Reservoir for Treatment of Macular Edema Secondary to Diabetes and Other Causes [NCT04005430] | Phase 1 | 1 participants (Actual) | Interventional | 2019-04-03 | Active, not recruiting |
| Monoclonal Antibody-Based Sequential Therapy for Deep Remission in Multiple Myeloma - MASTER Trial [NCT03224507] | Phase 2 | 123 participants (Actual) | Interventional | 2018-03-14 | Completed |
| Randomised Controlled Trial of Intravenous Dexamethasone to Prevent Relapse in the Treatment of Migraine in a Pediatric Emergency Department [NCT02903680] | Phase 1 | 116 participants (Anticipated) | Interventional | 2014-05-31 | Recruiting |
| A Phase III, Randomized, Multi-center, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Study the Safety, Tolerability and Efficacy of MK0869/Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) Associated Wit [NCT00952341] | Phase 3 | 421 participants (Actual) | Interventional | 2009-08-25 | Completed |
| A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND #101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age With FLT3 Mutated Acute M [NCT00651261] | Phase 3 | 717 participants (Actual) | Interventional | 2008-04-30 | Active, not recruiting |
| A Randomized, Double-Blind Comparison of Oral Aprepitant and Lower Dose Dexamethasone vs Aprepitant Alone for Preventing Postoperative Nausea and Vomiting After Elective Laparoscopic Surgeries [NCT00835965] | | 50 participants (Anticipated) | Interventional | 2009-02-28 | Not yet recruiting |
| A 5-year Multicenter Prospective Randomized Trial Comparing Three Conservative Chalazion Treatments [NCT01230593] | | 150 participants (Actual) | Interventional | 2010-11-30 | Completed |
| Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting After Laparoscopic Sleeve Surgery: a Randomized Controlled Trial [NCT04013386] | Phase 4 | 90 participants (Actual) | Interventional | 2019-07-15 | Completed |
| A Phase III, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of a Single Dose of Intravenous MK-0517 for the Prevention of Chemotherapy-Indu [NCT00619359] | Phase 3 | 2,322 participants (Actual) | Interventional | 2008-02-29 | Completed |
| Efficacy and Safety of the Association of Dexamethasone 0.5 mg + Clemastine Fumarate 1 mg When Compared to Dexamethasone 0.5 mg in Patients With Allergic Dermatitis [NCT01125761] | Phase 3 | 0 participants (Actual) | Interventional | 2010-11-30 | Withdrawn |
| Oral Versus Intravenous Dexamethasone in Community-Acquired Pneumonia [NCT01390012] | Phase 3 | 30 participants (Actual) | Interventional | 2011-08-31 | Completed |
| Randomized Open Investigation Determining Steroid Dose (ROIDS-Dose) [NCT04834375] | Phase 3 | 142 participants (Actual) | Interventional | 2021-03-19 | Completed |
| A Phase 1 Study of Temsirolimus in Combination With Intensive Re-induction Therapy for Children With Relapsed Acute Lymphoblastic Leukemia and Non-Hodgkin Lymphoma [NCT01403415] | Phase 1 | 13 participants (Actual) | Interventional | 2011-09-30 | Completed |
| A Phase II Study of Bendamustine, Velcade and Dexamethasone (BVD) in the Treatment of Elderly Patients (>= 65 Years) With Multiple Myeloma in 1st Relapse or Refractory to 1st Line Therapy [NCT01045681] | Phase 2 | 75 participants (Actual) | Interventional | 2010-03-03 | Completed |
| An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib) [NCT00608907] | Phase 1 | 61 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Iontophoresis Delivery of Dexamethasone Phosphate for Non-infectious, Non-necrotizing Anterior Scleritis, Phase 1 Dose-varying Study [NCT01059955] | Phase 1 | 18 participants (Actual) | Interventional | 2012-01-31 | Completed |
| Pemetrexed With Simplified Folate and Dexamethasone Supplementation Versus Pemetrexed With Standard Supplementation as Second-line Chemotherapy for Patients With Non-squamous Non-small Cell Lung Cancer [NCT00609518] | Phase 2 | 111 participants (Actual) | Interventional | 2008-02-29 | Completed |
| A Phase III, Randomized, Open-label, 3-arm Study to Determine the Efficacy and Safety of Lenalidomide(REVLIMID) Plus Low-dose Dexamethasone When Given Until Progressive Disease or for 18 Four-week Cycles Versus the Combination of Melphalan, Prednisone, an [NCT00689936] | Phase 3 | 1,623 participants (Actual) | Interventional | 2008-08-21 | Completed |
| A Pilot Study of Intravenous EZN-2285 (SC-PEG E. Coli L-asparaginase) or Intravenous Oncaspar® in the Treatment of Patients With High-Risk Acute Lymphoblastic Leukemia (ALL) [NCT00671034] | Phase 3 | 166 participants (Actual) | Interventional | 2008-07-21 | Completed |
| Dexamethasone as an Adjuvant to Ropivacaine for the Interscalene Brachial Plexus Block: a Dose-finding Study [NCT02818491] | Phase 4 | 75 participants (Actual) | Interventional | 2017-11-01 | Completed |
| A Single-center Clinical Trial to Evaluate the Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients [NCT05802992] | Phase 3 | 30 participants (Anticipated) | Interventional | 2022-03-30 | Recruiting |
| A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety and Efficacy of a Dexamethasone Iontophoretic Transdermal Patch for the Treatment of Pain Associated With Lateral Epicondylitis [NCT00794976] | Phase 2 | 216 participants (Actual) | Interventional | 2008-10-31 | Completed |
| Comparison of Single Dose Versus Two Doses of Oral Dexamethasone in the Management of Acute Asthma Exacerbations in the Pediatric Emergency Department. [NCT00942201] | | 125 participants (Actual) | Interventional | 2008-08-31 | Completed |
| A Phase I Single Arm Dose Escalation Study of the Combination of Dasatinib (Sprycel®) With Lenalidomide (Revlimid®) and Dexamethasone in Subjects With Relapsed and/ or Refractory Multiple Myeloma [NCT00560391] | Phase 1 | 35 participants (Actual) | Interventional | 2008-05-31 | Completed |
| A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Craniotomy [NCT00734929] | Phase 4 | 115 participants (Actual) | Interventional | 2007-09-30 | Completed |
| Treatment With Infusional Dose-adjusted Etoposide/Vincristine/Doxorubicin/Bolus Cyclophosphamide/Dexamethasone and Rituximab (DA-EDOCH14-R) in Patients With Poor-prognosis Diffuse Large B-cell Lymphoma [NCT01066429] | Phase 2 | 30 participants (Anticipated) | Interventional | 2009-12-31 | Recruiting |
| Intensified Tyrosine Kinase Inhibitor Therapy (Dasatinib NSC# 732517) in Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (ALL) [NCT00720109] | Phase 2/Phase 3 | 63 participants (Actual) | Interventional | 2008-07-14 | Completed |
| A Phase II Study of Anakinra (IL-1 Receptor Antagonist) in Patients With Smoldering/Indolent Multiple Myeloma [NCT00635154] | Phase 2 | 55 participants (Actual) | Interventional | 2002-12-31 | Completed |
| Evaluation the Effect of Diclofenac Drops vs Dexamethasone Drops in Trabeculectomy and Cataract Surgery [NCT00825864] | | 50 participants (Anticipated) | Interventional | 2004-01-31 | Completed |
| Prospective Randomized Controlled Trail of the Effects of Steroids on Swallowing, Airway and Arthrodesis Related to Myulti-Level Anterior Cervical Reconstruction [NCT01065961] | Phase 1/Phase 2 | 200 participants (Anticipated) | Interventional | 2008-11-30 | Recruiting |
| Ranibizumab and Dexamethasone Implant in Vitrectomized Eyes With Diabetic Macular Edema [NCT04089605] | Phase 4 | 48 participants (Actual) | Interventional | 2017-06-01 | Completed |
| A Phase I/2 Dose Escalation Safety, Pharmacokinetic and Efficacy Study of Multiple Intravenous Administrations of a Humanized Monoclonal Antibody (SAR650984) Against CD38 in Patients With Selected CD38+ Hematological Malignancies [NCT01084252] | Phase 1/Phase 2 | 351 participants (Actual) | Interventional | 2010-06-10 | Completed |
| A Phase II Study of IRD (Ixazomib, Lenalidomide, & Dexamethasone) for Consolidation Therapy Post Autologous Stem Cell Transplantation Followed by Maintenance Ixazomib or Lenalidomide for Multiple Myeloma [NCT02253316] | Phase 2 | 236 participants (Actual) | Interventional | 2015-01-20 | Active, not recruiting |
| UARK 2006-15: A Phase III Randomized Study of Tandem Transplants With or Without Bortezomib (Velcade) and Thalidomide (Thalomid) to Evaluate Its Effect on Response Rate and Durability of Response in Multiple Myeloma Patients [NCT00574080] | Phase 3 | 20 participants (Actual) | Interventional | 2006-07-31 | Terminated(stopped due to low accrual) |
| Postoperative Steroids and Recovery After Spine Fusion [NCT04568837] | Phase 4 | 420 participants (Anticipated) | Interventional | 2021-03-01 | Not yet recruiting |
| Randomized Clinical Trial of Dexamethasone Therapy in Very-Low-Birth-Weight Infants at Risk for Chronic Lung Disease (CLD) [NCT00011362] | Phase 3 | 371 participants (Actual) | Interventional | 1992-09-30 | Completed |
| Perineural Steroids for Saphenous Peripheral Nerve Blocks: An Equivalency Dosing Study. [NCT02462148] | Phase 4 | 85 participants (Actual) | Interventional | 2015-07-31 | Completed |
| Comparison of Early Changes in Ocular Surface and Inflammatory Mediators Among Lenticule Extraction, Laser in Situ Keratomileusis and Femtosecond Laser-assisted Laser in Situ Keratomileusis [NCT02551796] | | 75 participants (Actual) | Interventional | 2015-09-30 | Completed |
| [NCT01022528] | | 138 participants (Actual) | Interventional | 2009-03-31 | Completed |
| Anti-VEGF Therapy Versus Dexamethasone Implant for Treatment Naive Diabetic Macular Edema: A Randomized Controlled Trial [NCT03999125] | Phase 4 | 150 participants (Anticipated) | Interventional | 2019-06-25 | Not yet recruiting |
| High-dose Chemotherapy and Autologous Stem Cell Transplant or Consolidating Conventional Chemotherapy in Primary CNS Lymphoma - Randomized Phase III Trial [NCT02531841] | Phase 3 | 250 participants (Anticipated) | Interventional | 2014-07-31 | Recruiting |
| A Randomized Phase 2 Study of Daratumumab-Selinexor-Velcade-Dexamethasone (Dara-SVD) for High-Risk Newly Diagnosed Multiple Myeloma [NCT06169215] | Phase 2 | 82 participants (Anticipated) | Interventional | 2024-02-20 | Not yet recruiting |
| Dexamethasone in Total Knee Arthroplasty: What Dose Should we be Giving Patients Intraoperatively [NCT05018091] | Phase 4 | 429 participants (Anticipated) | Interventional | 2021-10-28 | Recruiting |
| Multiple Myeloma Treatment With Thalidomide. Three Randomized Studies on Thalidomide as Induction Treatment Before Autotransplant (MY-TAG) or With a Conventional Chemotherapy (MY-DECT) and as Consolidation/Maintenance at Plateau Phase (MY-PLAT). [NCT01070862] | Phase 3 | 0 participants | Interventional | 2003-05-31 | Completed |
| Pilot Study Evaluating Aprepitant (MK-869) for Prevention of Nausea & Vomiting Secondary to High Dose Cyclophosphamide Administered to Patients Underging Undergoing Peripheral Hematopoietic Progenitor Cell Mobilization Prior to Autologous Transplantation [NCT00293384] | | 40 participants (Actual) | Interventional | 2004-10-31 | Completed |
| A Pilot Study of Oncaspar® + Dexamethasone in Patients With Relapsed or Refractory T-Cell Lymphoma [NCT01878708] | Early Phase 1 | 2 participants (Actual) | Interventional | 2013-07-31 | Terminated(stopped due to Slow accrual) |
| Evaluation of Efficacy and Safety of Epidural Steroid Injection Using Dexamethasone or Betamethasone in Patients With Spinal Pain: a Prospective, Randomized, Double-blind Study [NCT01885481] | | 600 participants (Actual) | Interventional | 2013-10-31 | Completed |
| A Randomized, Controlled Phase 3 Study to Evaluate Optimized Retreatment and Prolonged Therapy With Bortezomib (Velcade) in Patients With Multiple Myeloma in First or Second Relapse. [NCT01910987] | Phase 3 | 80 participants (Actual) | Interventional | 2013-04-30 | Completed |
| A Randomized, National, Open-label, Multicenter, Phase III Trial Studying Induction Therapy With Bortezomib/Lenalidomide/Dexamethasone (VRD-GEM), Followed by High-dose Chemotherapy With Melphalan-200 (MEL-200) Versus Busulfan-melphalan (BUMEL), and Consol [NCT01916252] | Phase 3 | 460 participants (Anticipated) | Interventional | 2013-09-30 | Completed |
| Phase I/II Study of Bortezomib (VELCADE) Plus Rituximab-HyperCVAD Alternating With Bortezomib Plus Rituximab-High Dose Methotrexate/Cytarabine in Patients With Untreated Aggressive Mantle Cell Lymphoma [NCT00477412] | Phase 1/Phase 2 | 107 participants (Actual) | Interventional | 2007-04-03 | Completed |
| Oral Dexamethasone as an Adjunct to a Brachial Plexus Block in Patients Undergoing Orthopaedic Surgery of the Forearm and Hand. A Randomised, Blinded, Placebo-controlled, Parallel, Triple-arm Clinical Trial. [NCT04853446] | Phase 4 | 180 participants (Actual) | Interventional | 2021-06-28 | Completed |
| Comparison of Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Randomized Clinical Trial [NCT05988671] | Phase 3 | 120 participants (Anticipated) | Interventional | 2023-08-10 | Recruiting |
| A Phase 1 Trial to Evaluate the Safety of Single Agent Flotetuzumab in Advanced CD123-Positive Hematological Malignancies [NCT04681105] | Phase 1 | 13 participants (Actual) | Interventional | 2020-11-18 | Active, not recruiting |
| Delivery of Dexamethasone to the Adventitia to eNhance Clinical Efficacy After Femoropopliteal Revascularization [NCT01983449] | Phase 4 | 285 participants (Actual) | Interventional | 2013-11-30 | Completed |
| Combined Effect of Intravenous Lidocaine and Dexamethasone on Postoperative Sore Throat, Cough and Hoarseness. A Randomized Controlled Trial [NCT01990781] | Phase 4 | 180 participants (Actual) | Interventional | 2013-12-31 | Completed |
| A Randomized, Double-Blind, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compared to CIPRODEX® (Ciprofloxacin 0.3%/Dexamethasone 0.1%) Sterile Otic Suspens [NCT01994642] | Phase 3 | 203 participants (Actual) | Interventional | 2013-11-30 | Terminated(stopped due to FDA's draft guidance (revised March 2015) provided two options for determining bioequivalence: 1) in-vitro or 2) in-vivo studies) |
| Comparison of the Efficacy of Different Steroids in the Treatment of Abnormal Scars (Keloids, Hypertrophic Scars) [NCT04593706] | | 40 participants (Anticipated) | Interventional | 2020-11-01 | Not yet recruiting |
| Phase I/II Study of Carfilzomib in Combination With Bendamustine and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma [NCT02002598] | Phase 1/Phase 2 | 20 participants (Actual) | Interventional | 2013-11-30 | Completed |
| Phase II Study of Rituximab Given in Conjunction With Standard Chemotherapy in Primary Central Nervous System (CNS) Lymphoma [NCT00335140] | Phase 2 | 26 participants (Actual) | Interventional | 2007-08-23 | Terminated(stopped due to slow accrual) |
| Intravenous Versus Perineural Dexamethasone in Interscalene Nerve Block With Levobupivacaine for Shoulder and Upper Arm Surgeries [NCT04284007] | | 90 participants (Anticipated) | Interventional | 2019-12-02 | Enrolling by invitation |
| Epidural Dexamethasone for Labor Analgesia: the Effects on Ropivacaine Consumption and Labour Outcome. A Randomized Double Blind Placebo Study [NCT02857465] | Phase 3 | 0 participants (Actual) | Interventional | 2017-01-31 | Withdrawn(stopped due to French Agency for the Safety of Health Products refusal) |
| THE EFFECT OF THE COMBINATION OF DEXAMETHASONE WITH ONDANSETRON VERSUS DEXAMETHASONE WITH APREPITANT TO PREVENT POSTOPERATIVE NAUSEA AND VOMITING IN PATIENTS UNDERGOING LAPAROSCOPIC SURGERY [NCT02021851] | Phase 4 | 67 participants (Actual) | Interventional | 2011-07-31 | Completed |
| Phase 4 Study of Comparison of Postoperative Analgesic Effect of Intra-articular Dexamethasone and Dexamethasone Added to Bupivacaine in Interscalene Brachial Plexus Blockade for Arthroscopic Shoulder Surgery [NCT02026050] | Phase 4 | 75 participants (Actual) | Interventional | 2014-01-31 | Completed |
| Glucocorticoid Postauricular Injection Treatment for Sudden Hearing Loss: a Multi-center, Opened, Randomized, Controlled Clinical Trial [NCT02026479] | | 300 participants (Anticipated) | Interventional | 2014-01-31 | Not yet recruiting |
| Phase I/II Trial of AT-101 in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed Symptomatic Multiple Myeloma [NCT02697344] | Phase 1 | 10 participants (Actual) | Interventional | 2016-04-14 | Completed |
| Do Peri-operative High Doses of Intravenous Glucocorticoids Improve Short-term Functional Outcome After Direct Anterior Total Hip Arthroplasty? A Randomized, Single Surgeon, Placebo Controlled, Double Blind Study [NCT04317872] | | 70 participants (Anticipated) | Interventional | 2020-07-01 | Recruiting |
| A Randomized Controlled Clinical Trial aSsessing the Efficacy of DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert When Placed Within the Upper Eye Lid Canaliculus in Comparison to the Lower Lid Canaliculus Following Bilateral Cataract Extraction Su [NCT04592081] | Phase 4 | 20 participants (Anticipated) | Interventional | 2020-08-01 | Recruiting |
| Dexamethasone Dose for Postoperative Nausea and Vomiting Prophylaxis in Obese Patients [NCT04538820] | Phase 4 | 150 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
| Pre-surgical Ocular Surface Treatment With Intracanalicular Dexamethasone Insert and Effect on Intraocular Lens Measurement Accuracy - The PRECISION Study [NCT04530864] | Phase 4 | 35 participants (Anticipated) | Interventional | 2021-01-31 | Not yet recruiting |
| Investigation of Treatment With Topical Corticosteroid After Posterior Lamellar Corneal Transplantation [NCT01682421] | | 0 participants (Actual) | Interventional | 2012-09-30 | Withdrawn |
| Randomized, Controlled Trial Comparing Duration of Analgesia After Popliteal Fossa Sciatiac Nerve Block With Ropivacaine 0.5% When Combined With Placebo, Dexamethasone 4mg or Dexamethasone 8 mg [NCT01641419] | | 0 participants (Actual) | Interventional | 2012-07-31 | Withdrawn(stopped due to Inability to recruit subjects at our hospital due to change in surgical patient population. Not worth to continue.) |
| A Phase II Study of Ibrutinib Plus Rituximab Followed by Venetoclax and Hyper-CVAD Consolidation in Newly Diagnosed Young Patients With Mantle Cell Lymphoma: Window II Protocol [NCT03710772] | Phase 2 | 50 participants (Anticipated) | Interventional | 2019-05-01 | Active, not recruiting |
| Phase 2 Trial of Induction With Ixazomib, Pomalidomide, Dexamethasone Prior to Salvage Autologous Stem Cell Transplant Followed by Consolidation With Ixazomib, Pomalidomide, and Dexamethasone and Ixazomib Maintenance in Multiple Myeloma [NCT03202628] | Phase 2 | 8 participants (Actual) | Interventional | 2017-07-24 | Completed |
| Lead-In and Phase II Study of Clofarabine, Etoposide, Cyclophosphamide [CEC], Liposomal Vincristine (VCR), Dexamethasone and Bortezomib in Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma (LL) [NCT03136146] | Phase 2 | 42 participants (Anticipated) | Interventional | 2017-08-09 | Recruiting |
| Treatment of Patients With Newly Diagnosed Standard Risk B-Lymphoblastic Leukemia (B-ALL) or Localized B-Lineage Lymphoblastic Lymphoma (B-LLy) [NCT01190930] | Phase 3 | 9,350 participants (Actual) | Interventional | 2010-08-09 | Active, not recruiting |
| A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma [NCT01335399] | Phase 3 | 748 participants (Actual) | Interventional | 2011-08-04 | Completed |
| A Phase 1b Trial of AR-42 With Pomalidomide in Relapsed Multiple Myeloma [NCT02569320] | Phase 1 | 9 participants (Actual) | Interventional | 2016-05-20 | Completed |
| Efficacy of Prevention for Postoperative Nausea and Vomiting After Intrathecal Morphine in Cesarean Section: a Randomized Comparison of Metoclopramide or Ondansetron Alone or in the Combination With Dexamethasone. [NCT00892996] | | 120 participants (Actual) | Interventional | 2009-05-31 | Active, not recruiting |
| Objective Vestibular Evaluation & Rehabilitation With Intratympanic Dexamethasone and Gentamicin in Meniere's Disease [NCT05355610] | | 93 participants (Anticipated) | Interventional | 2021-04-01 | Recruiting |
| Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis: a Double-blind Randomized Trial [NCT00869310] | Phase 3 | 303 participants (Actual) | Interventional | 2009-09-30 | Terminated(stopped due to we terminated the study before enrolling 303/560 due to a slow accrual) |
| Intensified PEG-Asparaginase in High Risk Acute Lymphoblastic Leukemia (ALL): A Pilot Study [NCT00866307] | Phase 1 | 104 participants (Actual) | Interventional | 2009-02-23 | Completed |
| A Phase 2 Multicenter Study of First-line Dasatinib Plus Conventional Chemotherapy in Adults With Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia [NCT01004497] | Phase 2 | 51 participants (Actual) | Interventional | 2010-03-31 | Completed |
| A Phase I Study of Venetoclax in Combination With Cytotoxic Chemotherapy, Including Calaspargase Pegol, for Children, Adolescents and Young Adults With High-Risk Hematologic Malignancies [NCT05292664] | Phase 1 | 92 participants (Anticipated) | Interventional | 2023-03-29 | Recruiting |
| Interest of Cryotherapy or Cortisone Aerosol Therapy in Early Post-operative Swallowing Disorders Following Total Thyroidectomy [NCT02855866] | | 240 participants (Actual) | Interventional | 2013-09-03 | Completed |
| Lenalidomide, Bortezomib, and Dexamethasone Combination Therapy as Induction Followed by Bortezomib and Lenalidomide Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma [NCT03641456] | Phase 2 | 50 participants (Anticipated) | Interventional | 2020-09-25 | Recruiting |
| Intravenous Dexamethasone Versus Placebo for Ultrasound Guided Axillary Brachial Plexus Block With Ropivacaine: Randomised, Controlled, Clinical Trial [NCT02862327] | Phase 3 | 99 participants (Actual) | Interventional | 2016-12-01 | Completed |
| A Phase 3 Study of Velcade (Bortezomib) Dexamethasone (VD) Versus Velcade (Bortezomib) Thalidomide Dexamethasone (VTD) as an Induction Treatment Prior to Autologous Stem Cell Transplantation in Patients With Newly Diagnosed Multiple Myeloma [NCT00910897] | Phase 3 | 205 participants (Actual) | Interventional | 2008-03-31 | Active, not recruiting |
| [NCT02837614] | Early Phase 1 | 60 participants (Actual) | Interventional | 2015-10-31 | Completed |
| Comparison of Local and Intra Venous Dexamethasone on Post Operative Pain and Recovery After Caeseream Section [NCT02784340] | Phase 4 | 120 participants (Actual) | Interventional | 2014-05-31 | Completed |
| A Phase I/II Multicenter, Randomized, Open Label, Dose-Escalation Study To Determine The Maximum Tolerated Dose, Safety, And Efficacy Of CC-4047 Alone Or In Combination With Low-Dose Dexamethasone In Patients Wth Relapsed And Refractory Multiple Myeloma W [NCT00833833] | Phase 1/Phase 2 | 259 participants (Actual) | Interventional | 2008-06-30 | Completed |
| Treatment of Refractory Nausea [NCT03367572] | Phase 3 | 1,600 participants (Anticipated) | Interventional | 2018-04-19 | Recruiting |
| Effect of Intrathecal Dexamethasone Versus Fentanyl on Post Spinal Shivering in Patients Undergoing Transurethral Prostatectomy [NCT04178512] | | 51 participants (Anticipated) | Interventional | 2019-12-31 | Not yet recruiting |
| Epidural Levobupivacaine Versus A Combination of Levobupivacaine and Dexamethasone in Parturients Receiving Epidural for Vaginal Delivery Analgesia: A Comparative, Dose Ranging and Safety Evaluation Study [NCT02665936] | Phase 2 | 90 participants (Anticipated) | Interventional | 2015-10-31 | Active, not recruiting |
| MK0869 and MK0517 Time-on-Target PET Study [NCT01111851] | Phase 1 | 16 participants (Actual) | Interventional | 2010-04-30 | Completed |
| Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP): a Prospective, Randomized Controlled Trial [NCT02642380] | Phase 4 | 0 participants (Actual) | Interventional | 2015-11-30 | Withdrawn(stopped due to No eligible patient was enrolled.) |
| Radium-223 Combined With Dexamethasone as First-line Therapy in Patients With Metastatic Castrate Resistant Prostate Cancer [NCT03432949] | Phase 4 | 24 participants (Anticipated) | Interventional | 2018-02-23 | Recruiting |
| A Volunteer Study to Determine the Optimal Dose of IV Dexamethasone Required for Prolongation of Peripheral Nerve Block [NCT02864602] | Phase 3 | 18 participants (Actual) | Interventional | 2016-11-12 | Completed |
| Multinational European Trial for Children With the Opsoclonus Myoclonus Syndrome / Dancing Eye Syndrome [NCT01868269] | Phase 3 | 102 participants (Actual) | Interventional | 2013-04-18 | Active, not recruiting |
| Randomized Controlled Phase 2/3 Clinical Trial of NA-831 Alone or With Atazanavir, or NA-831 With Dexamethasone, or Atazanavir With Dexamethasone in the Treatment of COVID-19 Infection [NCT04452565] | Phase 2/Phase 3 | 525 participants (Anticipated) | Interventional | 2022-06-15 | Recruiting |
| An Open-label, Pharmacokinetic Study of Lenalidomide (Revlimid) and High-dose Dexamethasone Induction Therapy in Previously Untreated Multiple Myeloma Patients With Various Degrees of Renal Dysfunction - Validation of Official Dosing Guidelines for Renal [NCT01270932] | Phase 2 | 28 participants (Actual) | Interventional | 2010-11-30 | Completed |
| Intravenous Continuous Infusion of Dexamethasone Plus Tramadol Combined With Standard Morphine Patient-Controlled Analgesia After Total Abdominal Hysterectomy [NCT00564603] | Phase 4 | 300 participants (Actual) | Interventional | 2007-08-31 | Completed |
| Compared With Fosaprepitant Dimeglumine for Injection and Palonosetron Hydrochloride Injection, to Evaluate the Efficacy and Safety of HR20013 for Injection for Prevention of Chemotherapy-induced Nausea and Vomiting After Highly Emetogenic Chemotherapy [NCT05509634] | Phase 3 | 754 participants (Actual) | Interventional | 2022-09-21 | Completed |
| Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium [NCT05271058] | Phase 3 | 69 participants (Actual) | Interventional | 2019-06-16 | Completed |
| Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation [NCT05138029] | Phase 3 | 60 participants (Anticipated) | Interventional | 2021-11-15 | Recruiting |
| Dexamethasone Intravitreal Implant After Vitrectomy for Idiopathic Epiretinal Membrane [NCT01410201] | | 6 participants (Actual) | Interventional | 2011-08-31 | Terminated(stopped due to recruitment not met) |
| An Open-Label, Phase I Study to Assess the Pharmacokinetic Interaction Between Repeat Doses of Oral Casopitant and Intravenous and Oral Doses of Dexamethasone and Intravenous and Oral Doses of Ondansetron When Administered in Healthy Adult Subjects [NCT00437229] | Phase 1 | 37 participants (Actual) | Interventional | 2007-02-19 | Completed |
| Vorinostat (SAHA) Combined With High-Dose Gemcitabine, Busulfan, and Melphalan With Autologous Hematopoietic Cell Support for Patients With Relapsed or Refractory Lymphoid Malignancies [NCT01421173] | Phase 1 | 78 participants (Actual) | Interventional | 2011-08-31 | Completed |
| Comparison Between Prednisolone and Dexamethasone on D28 Mortality in Patients on Oxygen Therapy, With CoViD-19: Multicenter, Randomized, Open-label Non-inferiority Study [NCT04765371] | Phase 3 | 89 participants (Actual) | Interventional | 2021-03-03 | Completed |
| Evaluation of the Safety and Efficacy of VIGADEXA Ophthalmic Gel Compared to VIGADEXA Ophthalmic Solution in Preventing Inflammation and Infection Following Cataract Surgery [NCT01515826] | Phase 3 | 0 participants (Actual) | Interventional | 2014-03-31 | Withdrawn(stopped due to Management decision) |
| Ofatumumab (O) in Combination With Chemotherapy: Hyper-Fractionated Cyclophosphamide, Doxorubicin, Vincristine and Dexamethasone (O-HyperCVAD) Alternating With Ofatumumab High-Dose Cytarabine and Methotrexate (O-MA) for Patients With Newly Diagnosed Mantl [NCT01527149] | Phase 2 | 37 participants (Actual) | Interventional | 2011-12-06 | Active, not recruiting |
| The Effect of Prophylactic Antiemetic Dexamethasone on Plasma Cortisol Levels After Gynecologic Laparotomy [NCT01524731] | | 63 participants (Anticipated) | Interventional | 2012-05-31 | Completed |
| Effect Of Dexmedetomidine, Dexamethasone And Ondansetron On Postoperative Nausea And Vomiting In Children Undergoing Dental Rehabilitation [NCT05124067] | Phase 1 | 4 participants (Actual) | Interventional | 2021-10-27 | Completed |
| Tobramycin 0.3% - Dexamethasone 0.1% Versus Tobramycin 0.3% - Dexamethasone 0.1% Plus Ketorolac Tromethamine 0.5% After Phacoemulsification Surgery. A Randomized Trial [NCT00992355] | | 97 participants (Actual) | Interventional | 2009-01-31 | Completed |
| A Phase I Study of Panobinostat in Combination With Daratumumab, Bortezomib, and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma [NCT04956302] | Phase 1 | 1 participants (Actual) | Interventional | 2021-09-27 | Terminated(stopped due to PI Decision) |
| [NCT01854515] | | 90 participants (Anticipated) | Interventional | 2012-03-31 | Recruiting |
| TAHOE: Sustained InTravitreal DexAmetHasone Implant (Ozurdex) for Uveitic Macular Edema [NCT01870440] | Phase 4 | 10 participants (Actual) | Interventional | 2013-05-31 | Completed |
| Phase 1/2 Trial of Selinexor in Combination With Pomalidomide and Dexamethasone ± Carfilzomib for Patients With Proteasome-Inhibitor and Immunomodulatory Drug Refractory Multiple Myeloma (SCOPE) [NCT04764942] | Phase 1/Phase 2 | 81 participants (Anticipated) | Interventional | 2021-05-06 | Recruiting |
| A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Previously Untreated Multiple Myeloma Who Are Eligible for High-dose Therapy [NCT03710603] | Phase 3 | 690 participants (Actual) | Interventional | 2018-12-14 | Active, not recruiting |
| A Phase III, Multicenter, Randomized, Double-Blind, Active Controlled, Parallel Group Study of the Safety and Efficacy of the Intravenous and Oral Formulations of the Neurokinin-1 Receptor Antagonist Casopitant (GW679769) in Combination With Ondansetron a [NCT00366834] | Phase 3 | 1,840 participants (Actual) | Interventional | 2006-07-31 | Completed |
| A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With VBMCP-VBAD/Velcade Versus Thalidomide / Dexamethasone Versus Velcade / Thalidomide / Dexamethasone Followed by High Dose Intensive Therapy With Autolo [NCT00461747] | Phase 3 | 390 participants (Anticipated) | Interventional | 2006-03-31 | Completed |
| Intravenous Dexamethasone for the Early Treatment of Mild Acute Pancreatitis: A Double-Blind, Randomized, Placebo Controlled Trial [NCT01247961] | Phase 2 | 0 participants (Actual) | Interventional | 2010-11-30 | Withdrawn(stopped due to Investigator left institution) |
| A Double-Masked, Parallel-Group, Randomized, Single-Dose Bioequivalence Study of Tobradex AF Suspension and TOBRADEX Ophthalmic Suspension [NCT00362895] | Phase 3 | 995 participants (Actual) | Interventional | 2006-04-30 | Completed |
| A Groupwide Pilot Study to Test the Tolerability and Biologic Activity of the Addition of Azacitidine (NSC# 102816) to Chemotherapy in Infants With Acute Lymphoblastic Leukemia (ALL) and KMT2A (MLL) Gene Rearrangement [NCT02828358] | Phase 2 | 78 participants (Actual) | Interventional | 2017-04-01 | Active, not recruiting |
| A Phase II Open Label, Multicenter, Trial of JNJ-42756493 In Combination With Dexamethasone For The Treatment Of FGFR3 Wild-type Or Mutation Positive Relapsed and/or Refractory Multiple Myeloma [NCT02952573] | Phase 2 | 20 participants (Actual) | Interventional | 2017-06-13 | Terminated(stopped due to Low patient accrual) |
| Phase II Trial With Lenalidomide-Dexamethasone Combination in the Treatment of POEMS Syndrome. [NCT01639898] | Phase 2 | 51 participants (Actual) | Interventional | 2012-07-31 | Completed |
| DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001 [NCT04290676] | | 527 participants (Actual) | Observational | 2019-11-13 | Completed |
| The Effects and Dose Response of Dexamethasone on Intercostal Nerve Blocks With Bupivicaine in Post Thoracic Surgery Patients [NCT02936427] | Phase 3 | 60 participants (Anticipated) | Interventional | 2016-07-31 | Recruiting |
| A Phase III, Randomized Study of Daratumumab, Cyclophosphamide, Bortezomib and Dexamethasone (Dara-VCD) Induction Followed by Autologous Stem Cell Transplant or Dara-VCD Consolidation and Daratumumab Maintenance in Patients With Newly Diagnosed AL Amyloid [NCT06022939] | Phase 3 | 338 participants (Anticipated) | Interventional | 2023-10-31 | Not yet recruiting |
| Anosmia and / or Ageusia in COVID-19: Timeline, Treatment With Early Corticosteroid and Recovery [NCT04528329] | Phase 4 | 300 participants (Anticipated) | Interventional | 2021-03-30 | Recruiting |
| Phenotypic Personalized Medicine: Systematically Optimized Combination Therapy in Multiple Myeloma Using CURATE.AI [NCT03759093] | Phase 2/Phase 3 | 20 participants (Anticipated) | Interventional | 2023-09-10 | Recruiting |
| Modified BFM (Berlin-Frankfurt-Munster)Backbone Therapy for Chinese Children or Adolescents With Newly Diagnosed Lymphoblastic Lymphoma [NCT02845882] | Phase 3 | 150 participants (Anticipated) | Interventional | 2016-01-31 | Active, not recruiting |
| Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting Following High-dose Cisplatin in Nasopharyngeal Carcinoma Patients：a Randomized Phase 3 Trial [NCT02933099] | Phase 3 | 300 participants (Anticipated) | Interventional | 2016-10-31 | Not yet recruiting |
| Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery [NCT06086418] | Phase 4 | 90 participants (Anticipated) | Interventional | 2023-11-01 | Not yet recruiting |
| An Open Label, Phase 2 Study to Evaluate Activity and Safety of Daratumumab in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Plasmablastic Lymphoma (DALYA Trial) [NCT04915248] | Phase 2 | 28 participants (Anticipated) | Interventional | 2022-07-11 | Recruiting |
| A Phase 2, Open-label, Pharmacokinetic Study of a Single Intra-articular Administration of TLC599 in Subjects With Mild to Moderate Osteoarthritis of the Knee [NCT03754049] | Phase 2 | 102 participants (Anticipated) | Interventional | 2019-01-21 | Recruiting |
| A Randomized Controlled Trial Comparing Epinephrine and Dexamethasone to Placebo in the Treatment of Infants With Bronchiolitis [NCT03567473] | Phase 3 | 864 participants (Anticipated) | Interventional | 2018-12-13 | Recruiting |
| A Phase 2, Randomized Study of Bortezomib/Dexamethasone With or Without Elotuzumab in Subjects With Relapsed/Refractory Multiple Myeloma [NCT01478048] | Phase 2 | 185 participants (Actual) | Interventional | 2011-11-30 | Completed |
| Department of Hematologic Oncology, Sun Yat-sen University Cancer Center, Guangzhou, China [NCT04762745] | Phase 1/Phase 2 | 56 participants (Anticipated) | Interventional | 2021-02-28 | Not yet recruiting |
| Phase II Study of the Hyper-CVAD Regimen in Sequential Combination With Inotuzumab Ozogamicin as Frontline Therapy for Adults With B-Cell Lineage Acute Lymphocytic Leukemia [NCT03488225] | Phase 2 | 4 participants (Actual) | Interventional | 2018-03-28 | Terminated(stopped due to the study was closed early due to competing trials) |
| Phase 2 Trial of Pembrolizumab, Lenalidomide, and Dexamethasone for Initial Therapy of Newly Diagnosed Multiple Myeloma Eligible for Stem Cell Transplantation [NCT02880228] | Phase 2 | 11 participants (Actual) | Interventional | 2016-09-16 | Completed |
| A Prospective, Randomized Study on Intravitreal Ozurdex for Preventing Recurrent Vitreous Hemorrhage Following Pars Plana Vitrectomy for Proliferative Diabetic Retinopathy [NCT01478737] | Phase 2 | 100 participants (Anticipated) | Interventional | 2011-11-30 | Recruiting |
| A Randomized, Double-Masked Trial of Topical Dexamethasone 0.1%/Povidone-iodine 0.4% Versus Artificial Tears for Treatment of Viral Conjunctivitis [NCT01481519] | Phase 3 | 100 participants (Anticipated) | Interventional | 2011-12-31 | Completed |
| A Phase II Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-ranging, Parallel Group Study of the Safety and Efficacy of the Oral NeuroKinin-1 Receptor Antagonist, GW679769 in Combination With Ondansetron Hydrochloride and Dexamethasone for [NCT00104403] | Phase 2 | 722 participants (Actual) | Interventional | 2004-12-31 | Completed |
| Effect of Intravenous Versus Intrathecal Dexamethazone in Bupivacaine Spinal Anesthesia on Postdural Puncture Headache [NCT04709029] | | 220 participants (Anticipated) | Interventional | 2021-01-20 | Not yet recruiting |
| A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting Associated W [NCT00080444] | Phase 3 | 50 participants (Actual) | Interventional | 2004-04-30 | Completed |
| Efficacy of Antibiotic Steroid Combination Compared With Individual Administration in Prevention of Postoperative Inflammation in Patients Having Cataract Surgery [NCT00331084] | | 132 participants (Actual) | Interventional | 2006-04-30 | Completed |
| Dexamethasone Dosing Interval: 12 or 24 Hours Apart? A Randomized,Clinical Trial [NCT01697098] | Phase 2 | 200 participants (Actual) | Interventional | 2012-01-31 | Completed |
| Adjuncts for Adductor Block: Dexamethasone,Dexmedetomidine, or Combination to Reduce Pain. A Randomized Controlled Comparison of the Analgesic Effects Following ACL Repair [NCT03643822] | Phase 4 | 252 participants (Anticipated) | Interventional | 2020-02-21 | Active, not recruiting |
| Adductor Canal Block Versus Intra-articular Analgesia for Postoperative Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction: a Randomized Trial [NCT04715152] | Phase 2 | 72 participants (Anticipated) | Interventional | 2021-05-13 | Recruiting |
| A Multi-Center Randomized Study of Vincristine, Doxil and Dexamethasone vs. Vincristine, Doxorubicin, and Dexamethasone in Patients With Multiple Myeloma [NCT00344422] | Phase 3 | 198 participants (Actual) | Interventional | 2000-10-31 | Completed |
| The Effect of Systemic Prophylactic Dexamethasone on the Incidence of Postoperative Sore Throat in Patients Undergoing Ambulatory Laparoscopic Gynecologic Surgery: A Prospective, Randomized, Double Blinded, Placebo Controlled Trial [NCT01052038] | Phase 4 | 120 participants (Actual) | Interventional | 2010-01-31 | Completed |
| Antiemetic and Analgesic Efficacy and Safety of Dexamethasone for Paediatric Adeno-tonsillectomy - A Randomised, Placebo-controlled, Double-blind, Dose-finding Study [NCT00403806] | Phase 4 | 215 participants (Actual) | Interventional | 2005-02-28 | Terminated(stopped due to drug-related harm) |
| Study of Efficacy of PAD-regimen(Bortezomib,Pirarubicin and Dexamethasone) and TAD-regimen(Thalidomide,Pirarubicin and Dexamethasone) in Newly Diagnosed Multiple Myeloma,Influence in Concentration of Bone Metabolites,and the Relations With Different Cytog [NCT01249690] | Phase 4 | 100 participants (Anticipated) | Interventional | 2010-06-30 | Recruiting |
| A Randomized Phase 2 Trial of Lenalidomide/ Dexamethasone/ Elotuzumab +/- Cyclophosphamide Followed by Lenalidomide/ Dexamethasone/Elotuzumab Maintenance as Second-Line Therapy for Patients With Relapsed AL Amyloidosis [NCT03252600] | Phase 2 | 53 participants (Anticipated) | Interventional | 2017-08-25 | Active, not recruiting |
| Phase I Study of Palbociclib Alone and in Combination in Patients With Relapsed and Refractory Leukemias [NCT03132454] | Phase 1 | 54 participants (Anticipated) | Interventional | 2017-07-25 | Recruiting |
| A Phase II Trial For High-Risk Myeloma Evaluating Accelerating and Sustaining Complete Remission (AS-CR) by Applying Non-Host-Exhausting and Timely Dose-Reduced Mel-80-CFZ-TD-Pace Transplant(s) With Interspersed Mel-20-CFZ-TD-Pace With CFZ-RD and CFZ-D Ma [NCT02128230] | Phase 2 | 20 participants (Actual) | Interventional | 2014-06-10 | Terminated(stopped due to Low enrollment and Futility as determined by Amgen's Carfilzomib NASCR program.) |
| Single Arm Study on Treatment Algorithm to Justify Steroid Use in Selected Preterm Neonates to Prevent Bronchopulmonary Dysplasia [NCT03035214] | Phase 2 | 30 participants (Anticipated) | Interventional | 2017-02-19 | Recruiting |
| The Effect of Zinc, Beta-carotene, and Vitamin D3 Supplementation as Pro-inflammation Mediated Regulator in Preterm Delivery Through Placental Protein Adaptor MyD88 and TRIF, Transcription Factor NFkB, and Pro-inflammatory Cytokine IL-1β [NCT03005496] | Phase 4 | 56 participants (Actual) | Interventional | 2017-01-31 | Completed |
| Intravenous Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia and Allergy to E. Coli Asparaginase (IND 104224) [NCT00928200] | Phase 1 | 1 participants (Actual) | Interventional | 2009-04-13 | Terminated(stopped due to Study was terminated due to lack of accrual.) |
| Multicenter, Open-label, Single-arm, Phase 1b/2 Study of the Safety and Efficacy of Combination Treatment w/ Carfilzomib, Lenalidomide (Revlimid®) and Dexamethasone (CRD) in Subjects w/ Newly Diagnosed, Previously Untreated Multiple Myeloma Requiring Syst [NCT01029054] | Phase 1/Phase 2 | 53 participants (Actual) | Interventional | 2009-09-30 | Completed |
| A Phase 2 Study of Clofarabine, Idarubicin, Cytarabine, Vincristine, and Corticosteroids for Patients With Newly Diagnosed or Relapsed Mixed Phenotype Acute Leukemia [NCT02135874] | Phase 2 | 18 participants (Actual) | Interventional | 2014-10-27 | Completed |
| Phase II Study of Hyper-CVAD Plus Nelarabine in Previously Untreated T-ALL and Lymphoblastic Lymphoma [NCT00501826] | Phase 2 | 160 participants (Anticipated) | Interventional | 2007-07-11 | Recruiting |
| Effect of Ozurdex® 0.7 mg on Improvement of Efficacy of Bevacizumab Therapy for Non-Ischemic Central Retinal Vein Occlusion [NCT01295112] | Phase 2/Phase 3 | 68 participants (Actual) | Interventional | 2011-05-31 | Completed |
| Phase II Study of the Hyper - CVAD Regimen in Combination With Ofatumumab as Frontline Therapy for Patients With CD-20 Positive Acute Lymphoblastic Leukemia [NCT01363128] | Phase 2 | 72 participants (Actual) | Interventional | 2011-07-12 | Completed |
| Phase II Trial of Sequential Treatment of Multiple Myeloma With Antibody Therapy [NCT03713294] | Phase 2 | 41 participants (Anticipated) | Interventional | 2018-12-19 | Active, not recruiting |
| A Phase I-II Study of the Combination of Ruxolitinib or Dasatinib With Chemotherapy in Patients With Philadelphia Chromosome (Ph)-Like Acute Lymphoblastic Leukemia (ALL) [NCT02420717] | Phase 2 | 11 participants (Actual) | Interventional | 2015-07-15 | Terminated(stopped due to Study was closed early due to low accrual and lack of response.) |
| A Phase 1/1a Study of Venetoclax, MLN9708 (Ixazomib Citrate) and Dexamethasone for Relapsed/Refractory Light Chain Amyloidosis [NCT04847453] | Phase 1 | 24 participants (Anticipated) | Interventional | 2022-08-03 | Recruiting |
| A Phase III Randomized Trial of Steroids + Tyrosine Kinase Inhibitor (TKI) Induction With Chemotherapy or Blinatumomab for Newly Diagnosed BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL) in Adults [NCT04530565] | Phase 3 | 348 participants (Anticipated) | Interventional | 2021-01-25 | Recruiting |
| Nausea and Pain Prophylaxis During Thyroid Surgery, a Comparison of Low-Dose and High-Dose Dexamethasone to Placebo [NCT00569920] | | 120 participants (Anticipated) | Interventional | 2007-09-30 | Completed |
| A Novel Therapeutic Approach for Controlling Complications Associated With Impacted Mandibular Third Molar Removal [NCT04848259] | Early Phase 1 | 80 participants (Actual) | Interventional | 2021-01-05 | Completed |
| A Phase 1/2 Open-label Study to Assess the Safety, Tolerability and Preliminary Efficacy of TH-302, A Hypoxia-Activated Prodrug, and Dexamethasone With or Without Bortezomib or Pomalidomide in Subjects With Relapsed/Refractory Multiple Myeloma [NCT01522872] | Phase 1/Phase 2 | 98 participants (Anticipated) | Interventional | 2012-02-29 | Active, not recruiting |
| Phase 2 Trial of Ixazomib Combinations in Patients With Relapsed Multiple Myeloma [NCT01415882] | Phase 2 | 108 participants (Actual) | Interventional | 2012-01-31 | Active, not recruiting |
| Intraoperative Dexamethasone Implant (Ozurdex®) Improves Outcome of Cataract Surgery in Patients With Diabetic Macular Edema [NCT01546402] | Phase 4 | 20 participants (Actual) | Interventional | 2011-05-31 | Completed |
| Iberoamerican Phase III International Study, Open, Multicenter, Randomized, Comparative of Thalidomide / Cyclophosphamide / Dexamethasone Versus Thalidomide / Dexamethasone Versus Thalidomide / Melphalan / Prednisone as Induction Therapy Followed by Maint [NCT01532856] | Phase 3 | 64 participants (Actual) | Interventional | 2007-01-31 | Active, not recruiting |
| Effect of Paracetamol Versus Paracetamol Combined With Pregabalin Versus Paracetamol Combined With Pregabalin and Dexamethasone on Pain and Opioid Requirements in Patients Scheduled for Tonsillectomy [NCT00378547] | Phase 4 | 147 participants (Actual) | Interventional | 2006-01-31 | Terminated(stopped due to ENT surgery stopped at the recruiting hospital) |
| [NCT01540812] | | 418 participants (Actual) | Observational | 2012-02-29 | Completed |
| [NCT01543945] | Phase 2 | 340 participants (Actual) | Interventional | 2008-03-31 | Completed |
| Effects of a Single Dose of Dexamethasone in Patients Undergoing Operative Fixation of Proximal Femur Fracture [NCT01550146] | Phase 4 | 40 participants (Anticipated) | Interventional | 2009-07-31 | Recruiting |
| A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery [NCT04711213] | Phase 2 | 60 participants (Actual) | Interventional | 2020-09-14 | Completed |
| Randomised Comparisons, in Myeloma Patients of All Ages, of Thalidomide, Lenalidomide, Carfilzomib and Bortezomib Induction Combinations, and of Lenalidomide and Combination Lenalidomide Vorinostat as Maintenance (Myeloma XI) [NCT01554852] | Phase 3 | 4,420 participants (Actual) | Interventional | 2010-05-31 | Active, not recruiting |
| Velcade/Dexamethasone/Cyclophosphamide(PCD) Versus Rituximab /Dexamethasone/Cyclophosphamide(RCD) for the Treatment of Patients With Waldenstrom's Macroglobulinemia [NCT02971982] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2016-10-31 | Recruiting |
| High Dose Oral Steroids in Sudden Sensorineural Hearing Loss [NCT03255473] | Phase 2 | 4 participants (Actual) | Interventional | 2017-08-30 | Completed |
| An Investigation of Postoperative Pain, Why Still in Hospital and Days Alive and Out of Hospital Following Transoral Robotic Surgery for Squamous Cell Carcinoma of Unknown Primary and Obstructive Sleep Apnea [NCT04189107] | Phase 3 | 18 participants (Actual) | Interventional | 2020-08-18 | Completed |
| A Multicenter, Randomized, Parallel-group , Double Blind, Placebo-controlled Study of Combination Thalidomide Plus Dexamethasone Therapy vs. Dexamethasone Therapy Alone as Induction Therapy for Previously Untreated Subjects With Multiple Myeloma [NCT00057564] | Phase 3 | 470 participants (Actual) | Interventional | 2003-02-28 | Completed |
| Intraluminal Ureteric Injection of High Concentration Alkalinised Long-acting Local Anaesthetic and STeroid Post urEteroscopy: A Prospective Double Blinded Randomised Controlled Trial (LASTE Trial) [NCT03296189] | | 150 participants (Anticipated) | Interventional | 2018-11-01 | Not yet recruiting |
| Hormonal Mechanisms of Sleep Restriction - Axis Study [NCT03142893] | Phase 1 | 80 participants (Anticipated) | Interventional | 2017-05-08 | Active, not recruiting |
| A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia ( [NCT00199186] | Phase 2 | 0 participants | Interventional | 2002-03-31 | Recruiting |
| PH Ib Study of Elotuzumab in Combination With Lenalidomide and Dexamethasone in Subjects With Multiple Myeloma and Normal Renal Function, Severe Renal Impairment, or End Stage Renal Disease Requiring Dialysis [NCT01393964] | Phase 1 | 35 participants (Actual) | Interventional | 2012-01-06 | Completed |
| A Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Subjects With Previously Untreated Multiple Myeloma [NCT01891643] | Phase 3 | 23 participants (Actual) | Interventional | 2013-09-30 | Terminated(stopped due to Insufficient enrollment) |
| A Phase I/II Assessment of Combination Immuno-Oncology Drugs Elotuzumab, Anti-LAG-3 (BMS-986016) and Anti-TIGIT (BMS-986207) [NCT04150965] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2020-06-30 | Active, not recruiting |
| The Evaluation of Erector Spinae Plane Block for the Pain Control of Thoracic Postherpetic Neuralgia [NCT03595046] | | 0 participants (Actual) | Interventional | 2018-07-31 | Withdrawn(stopped due to It was difficult to recruit subjects.) |
| Étude Pilote DEXEL-RH: Comparaison de Deux schémas Posologiques de DEXaméthasone en prévention Des Réactions d'Hypersensibilité au paclitaXEL [NCT01797991] | | 30 participants (Actual) | Interventional | 2013-02-28 | Completed |
| [NCT00168324] | Phase 3 | 599 participants (Actual) | Interventional | 2004-10-01 | Completed |
| A Randomized, Double-blind, Double-dummy, Active-controlled, Parallel Group Study of a Single Dose of ACZ885 in Hospitalized Patients With Acute Gout [NCT00663169] | Phase 2 | 6 participants (Actual) | Interventional | 2008-04-30 | Completed |
| ApRepitant in Combination With Granisetron and Dexamethasone versUs Granisetron and dexamEthasone for the Prevention of Vomiting in Patients With HAIC Therapy for Hepatocellular Carcinoma: a Randomized Controlled Study (ARGUE) [NCT05711823] | Phase 3 | 300 participants (Anticipated) | Interventional | 2023-07-01 | Not yet recruiting |
| Yale Steroid Enhanced Versus Exparel Nerveblock TKA Part 2 [NCT05736549] | Phase 2 | 66 participants (Anticipated) | Interventional | 2023-02-07 | Recruiting |
| Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL) [NCT02999633] | Phase 2 | 14 participants (Actual) | Interventional | 2017-03-08 | Terminated(stopped due to Due to an unsatisfactory benefit/risk ratio, as specified in & 14.8.1 of the protocol, Sanofi decided to stop enrollment and terminate ACT14596 prematurely) |
| Ozurdex in Treatment of Macular Edema Post Membrane Peeling [NCT01273727] | Phase 2/Phase 3 | 35 participants (Actual) | Interventional | 2010-06-30 | Completed |
| LIMBO-PTA: Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Percutaneous Transluminal Angioplasty Revascularization [NCT02479555] | Phase 2 | 120 participants (Anticipated) | Interventional | 2016-01-31 | Recruiting |
| A Comparison of Ropivacaine Alone Versus Ropivacaine With Dexamethasone or Clonidine Versus a Combination of Ropivacaine, Dexamethasone, and Clonidine for Supraclavicular Brachial Plexus Block Using Ultrasound:A Prospective, Observer-blinded, Randomized S [NCT02151487] | | 97 participants (Actual) | Observational | 2014-03-31 | Completed |
| Efficacy of Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19 [NCT04726098] | Phase 4 | 198 participants (Actual) | Interventional | 2021-01-15 | Completed |
| Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy [NCT02506660] | Phase 4 | 128 participants (Actual) | Interventional | 2015-08-31 | Completed |
| The Effects of Perineural Versus Intravenous Dexamethasone on Sciatic Nerve Blockade Outcomes [NCT01616173] | Phase 4 | 80 participants (Actual) | Interventional | 2012-06-30 | Completed |
| The Effects of Systemic Steroids on the Duration of a Psoas Compartment Block. [NCT02464176] | Phase 4 | 115 participants (Actual) | Interventional | 2015-06-30 | Completed |
| Phase Ib/II Study of the Combination of Low-Intensity Chemotherapy and Tagraxofusp in Patients With Acute Lymphoblastic Leukemia (ALL) [NCT05032183] | Phase 1/Phase 2 | 40 participants (Anticipated) | Interventional | 2022-02-17 | Recruiting |
| Slow Heart Registry: A Prospective Observational Cohort Study of Fetal Immune-mediated High Degree Heart Block [NCT04559425] | | 350 participants (Anticipated) | Observational [Patient Registry] | 2020-01-01 | Recruiting |
| Post-Operative Dosing of Steroids Post Craniotomy for Brain Tumor (PODS) [NCT06132685] | Phase 2 | 200 participants (Anticipated) | Interventional | 2023-12-01 | Not yet recruiting |
| An International, Multicenter, Non-Randomized, Open-Labeled Study to Evaluate the Efficacy of Lower Dose Dexamethasone/Thalidomide and Higher Frequency ZOMETA(TM) in the Treatment of Previously Untreated Patients With Multiple Myeloma [NCT00263484] | Phase 2 | 56 participants (Actual) | Interventional | 2005-12-31 | Completed |
| Efficacy and Safety of Rituximab, High-dose Ara-C and Dexamethasone (R-HAD) Alone or in Combination With Bortezomib in Patients With Relapsed or Refractory Mantle Cell Lymphoma [NCT01449344] | Phase 3 | 128 participants (Actual) | Interventional | 2009-05-09 | Active, not recruiting |
| A Phase I Study of Arsenic Trioxide and Ascorbic Acid (ATO/AA) in Combination With Low Dose Velcade-Thalidomide-Dexamethasone (VTD) in Relapsed/Refractory Multiple Myeloma (MM) [NCT00258245] | Phase 1 | 5 participants (Actual) | Interventional | 2005-05-31 | Completed |
| A Phase 1 Dose-Escalation and Exploratory Dose Expansion Study of KRT-232 (AMG 232) in Combination With Carfilzomib, Lenalidomide, and Dexamethasone in Relapsed and/or Refractory Myeloma [NCT03031730] | Phase 1 | 40 participants (Anticipated) | Interventional | 2018-06-14 | Recruiting |
| Randomized Phase III Trial of Bortezomib, Lenalidomide, and Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide, and Dexamethasone (CRd) Followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients With Newly Diagnosed Symptomatic Mult [NCT01863550] | Phase 3 | 1,087 participants (Actual) | Interventional | 2013-12-06 | Active, not recruiting |
| [NCT01495624] | | 16 participants (Actual) | Interventional | 2011-12-31 | Terminated(stopped due to Accrual insufficient to complete study in a feasible time frame) |
| A Randomized Controlled Multi-center Clinical Trial on Treatment of Stage I/II NK/T Cell Lymphoma With DDGP Regiment (Gemcitabine,Pegaspargase,Cisplatin,Dexamethasone) [NCT01501136] | Phase 4 | 200 participants (Anticipated) | Interventional | 2011-01-31 | Recruiting |
| A Phase II, Multi-center, Open-label, Randomized Study of Vorinostat Plus Lenalidomide and Dexamethasone or Lenalidomide Plus Dexamethasone in Multiple Myeloma Patients Who Experience Biochemical Relapse During Lenalidomide Maintenance Therapy [NCT01501370] | Phase 2 | 0 participants (Actual) | Interventional | 2012-01-31 | Withdrawn |
| Dexamethasone Infusion to the Adventitia to Enhance Clinical Efficacy After Femoropopliteal Revascularization [NCT01507558] | | 22 participants (Actual) | Interventional | 2010-12-31 | Completed |
| Efficacy of Aprepitant (Emend®) in Children Receiving Highly Emetogenic Chemotherapy [NCT01661335] | Phase 3 | 19 participants (Actual) | Interventional | 2012-06-01 | Completed |
| Dexamethasone to Target Stress and Immune System Changes During Early Abstinence in Individuals With Alcohol Use Disorder (AUD) [NCT05305404] | Early Phase 1 | 70 participants (Anticipated) | Interventional | 2022-03-11 | Recruiting |
| Dexamethasone for the Prevention of a Pain Flare After Palliative Radiotherapy for Painful Bone Metastases: a Multi-center Double-blind Placebo-controlled Randomized Study [NCT01669499] | Phase 3 | 411 participants (Anticipated) | Interventional | 2012-01-31 | Completed |
| Role of Intraoperative Dexamethasone Implant in Improving Outcome of Taut Posterior Hyaloid Removal in Diabetic Macular Edema [NCT01698788] | | 5 participants (Actual) | Interventional | 2011-05-31 | Completed |
| Phase 1 Clinical Trial of a Novel CDK Inhibitor Dinaciclib (SCH 727965) in Combination With Bortezomib and Dexamethasone in Relapsed Multiple Myeloma [NCT01711528] | Phase 1 | 41 participants (Actual) | Interventional | 2012-12-19 | Completed |
| A Comparative, Randomised Controlled Trial for Evaluating the Efficacy of Dexamethasone in the Treatment of Patients With Acute Respiratory Distress Syndrome [NCT01731795] | Phase 4 | 277 participants (Actual) | Interventional | 2013-03-28 | Completed |
| A Multicentre Investigation of Recombinant Human Thrombopoietin (rhTPO) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP) [NCT01734044] | Phase 3 | 158 participants (Actual) | Interventional | 2012-07-31 | Completed |
| Postoperative Vomiting in Children: Evaluation of the Addition of Droperidol to Conventional Bi-prophylaxis [NCT01739985] | | 322 participants (Actual) | Interventional | 2010-12-31 | Completed |
| A Pilot Study of the Effect of Intravitreal Dexamethasone Implant (700 Micrograms) on Diabetic Macular Edema After Cataract Surgery [NCT01748487] | Phase 3 | 24 participants (Actual) | Interventional | 2012-12-31 | Completed |
| MRD-Guided Sequential Therapy For Deep Response in Newly Diagnosed Multiple Myeloma - MASTER-2 Trial [NCT05231629] | Phase 2 | 300 participants (Anticipated) | Interventional | 2023-12-13 | Recruiting |
| A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Darat [NCT03871829] | Phase 2 | 88 participants (Actual) | Interventional | 2019-05-31 | Terminated(stopped due to The decision was made to discontinue the 54767414MMY2065 study as the Data Review Committee recommendation was early stop of the study for futility.) |
| MAGNETISMM-1 A PHASE I, OPEN LABEL STUDY TO EVALUATE THE SAFETY, PHARMACOKINETIC, PHARMACODYNAMIC AND CLINICAL ACTIVITY OF ELRANATAMAB (PF-06863135), A B-CELL MATURATION ANTIGEN (BCMA) - CD3 BISPECIFIC ANTIBODY, AS A SINGLE AGENT AND IN COMBINATION WITH I [NCT03269136] | Phase 1 | 101 participants (Actual) | Interventional | 2017-11-29 | Active, not recruiting |
| PRevention of Macular EDema After Cataract Surgery [NCT01774474] | Phase 3 | 1,127 participants (Actual) | Interventional | 2013-07-10 | Completed |
| UARK 2013-13, Total Therapy 4B - Formerly 2008-01 - A Phase III Trial for Low Risk Myeloma Ages 65 and Under: A Trial Enrolling Subjects to Standard Total Therapy 3 (S-TT3) [NCT00734877] | Phase 3 | 382 participants (Actual) | Interventional | 2008-07-31 | Active, not recruiting |
| Phase III-study for Evaluation of Induction Therapy Before Stem Cell Mobilization and Tandem High-dose Melphalan in Multiple Myeloma Patients 60 to 70 Years of Age [NCT02288741] | Phase 3 | 549 participants (Actual) | Interventional | 2001-08-31 | Completed |
| Ozurdex Versus Ranibizumab Versus Combination for Central Retinal Vein [NCT01827722] | Phase 4 | 45 participants (Anticipated) | Interventional | 2013-05-31 | Recruiting |
| Treatment of Brain Metastases From Breast Cancer With Eribulin Mesylate [NCT02581839] | Phase 2 | 9 participants (Actual) | Interventional | 2015-11-17 | Completed |
| Phase I/II Study of Twice Weekly Ixazomib Plus Pomalidomide and Dexamethasone in Relapsed/or Refractory Multiple Myeloma [NCT04094961] | Phase 1/Phase 2 | 61 participants (Anticipated) | Interventional | 2019-09-18 | Recruiting |
| Impact of First Autologous Transplant on Minimal Residual Disease Markers in Previously Untreated Myeloma Undergoing Initial Treatment With Velcade Based Therapy [NCT01215344] | Phase 2 | 36 participants (Actual) | Interventional | 2010-11-30 | Completed |
| Clinical Assessment of Combined Vitrectomy and Femtosecond Laser-assisted Cataract Surgery [NCT05588037] | | 100 participants (Anticipated) | Interventional | 2017-01-01 | Recruiting |
| Pre-Transplant Immunosuppression and Related Haploidentical Hematopoietic Cell Transplantation for Patients With Severe Hemoglobinopathies [NCT04776850] | Early Phase 1 | 0 participants (Actual) | Interventional | 2020-12-29 | Withdrawn(stopped due to Competing protocol opened in Adult SCT that will include pediatric patients and is now multi-center. No patients enrolled on study.) |
| The Effect of Steroid on Reducing Facial Swelling After Orthognathic Surgery [NCT01431014] | Phase 4 | 56 participants (Actual) | Interventional | 2011-08-31 | Completed |
| A Randomized, Placebo Controlled, Double Blinded Study of Corticosteroid Treatment for the Reduction of Postoperative Pain Following Transoral Robotic Surgery [NCT01748942] | | 76 participants (Actual) | Interventional | 2012-12-31 | Completed |
| Perioperative Dexamethasone to Promote Systemic Pro-Resolution Phenotype for Prevention of Acute and Chronic Pain Post-Total Knee Arthroplasty. [NCT02271698] | Phase 4 | 45 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Comparison of Dexamethasone Oral Preparations to Assess Palatability and Adverse Effects in Children With Asthma and Croup [NCT03705273] | Phase 4 | 40 participants (Actual) | Interventional | 2018-10-23 | Terminated(stopped due to Dr. Arnold assisted in designing and initiating study for a pharmacology PhD candidate. The candidate left the institution and study enrollment was terminated.) |
| Safely Stopping Pre-Medications in Patients Receiving Paclitaxel: A Randomized Trial [NCT04862585] | Phase 2/Phase 3 | 100 participants (Anticipated) | Interventional | 2021-10-07 | Recruiting |
| A Randomized Phase I/II Study of Bortezomib, Rituximab, Dexamethasone and Temsirolimus in Patients With Relapsed Waldenstrom Macroglobulinemia and Relapsed/Refractory Mantle Cell, Follicular, Marginal Zone or Small Lymphocytic Lymphomas (Phase I), and Unt [NCT01381692] | Phase 1/Phase 2 | 9 participants (Actual) | Interventional | 2011-07-20 | Completed |
| Evaluation of Intravenous Glucocorticoid Therapy in Total Knee Arthroplasty [NCT02219581] | Phase 4 | 1 participants (Actual) | Interventional | 2014-10-16 | Terminated(stopped due to Terminated after considerable time in suspended state due to inadequate staffing, the COVID pandemic, and the Responsible Party leaving Emory in August 2022.) |
| Phase 1 Study of Daratumumab When Given in Combination With Bortezomib, Dexamethasone, Doxil, and Lenalidomide in Patients With Plasma Cell Leukemia [NCT03591744] | Phase 1 | 0 participants (Actual) | Interventional | 2018-10-25 | Withdrawn(stopped due to Budgetary constraints) |
| Comparison of Three Different Prophylactic Treatments of PONV in Children [NCT01434017] | Phase 4 | 300 participants (Actual) | Interventional | 2008-11-30 | Completed |
| Effect of Intraligmentary Dexamethasone on Anesthetic Efficacy of Inferior Alveolar Nerve Block Versus Buccal Infiltratation in Lower First Molars With Irreversible Pulpitis and Apical Periodontits: A Randomized Clinical Trial [NCT05928611] | | 81 participants (Anticipated) | Interventional | 2023-08-31 | Not yet recruiting |
| Continuing Treatment for Subjects Who Have Participated in a Prior Protocol Investigating Elotuzumab [NCT02719613] | Phase 2 | 67 participants (Actual) | Interventional | 2016-07-15 | Active, not recruiting |
| Utilization of Erector Spinae Plane Blocks in a Multimodal Analgesic Pathway for Instrumentation and Fusion of Adolescent Idiopathic Scoliosis: A Feasibility Study [NCT04500613] | | 24 participants (Anticipated) | Interventional | 2021-02-22 | Enrolling by invitation |
| The Effects of Dexamethasone Administration on Jaundice Following Liver Resection: a Randomized Controlled Trial [NCT02991339] | Phase 2/Phase 3 | 76 participants (Actual) | Interventional | 2016-06-30 | Completed |
| Dexamethasone At-induction vs At-night to Prevent Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy: A Protocol for Randomized Clinical Trial [NCT05998317] | Phase 2/Phase 3 | 60 participants (Anticipated) | Interventional | 2023-10-08 | Recruiting |
| Surgery Prevention by Transforaminal Injection of Epidural Steroids for Cervical Radicular Pain (SPIES): a Randomized, Controlled Trial [NCT02226159] | Phase 4 | 65 participants (Actual) | Interventional | 2014-08-31 | Active, not recruiting |
| Randomized Double Blind Study to Evaluate the Efficacy of IV Palo w/ IV Dexamethasone vs IV Palo for Prevention of Immediate & Delayed Post-Operative Nausea/Vomiting in Subj Undergoing Laparoscopic Surgeries w/a High Emetogenic Risk [NCT00952133] | Phase 4 | 118 participants (Actual) | Interventional | 2009-07-31 | Completed |
| Maintenance Therapy With Belantamab, Pomalidomide and Dexamethasone (BPd) in High-Risk Myeloma Patients: A Phase 2 Study With a Safety Run-In [NCT05208307] | Phase 2 | 34 participants (Anticipated) | Interventional | 2022-07-21 | Recruiting |
| The Effects of Corticosteroids, Glucose Control, and Depth-of-Anesthesia on Perioperative Inflammation and Morbidity From Major Non-cardiac Surgery (Dexamethasone, Light Anesthesia and Tight Glucose Control (DeLiT Trial)) [NCT00995501] | | 381 participants (Actual) | Interventional | 2007-01-31 | Terminated(stopped due to Per interim analysis, for futility.) |
| A Phase I Study Evaluating Copanlisib in Combination With R-GCD (Gemcitabine, Carboplatin, Dexamethasone, and Rituximab) With Relapsed/Refractory Diffuse Large B-Cell Lymphoma and High-Risk Follicular Lymphoma [NCT04156828] | Phase 1 | 12 participants (Actual) | Interventional | 2020-03-31 | Terminated(stopped due to Terminated due to low accrual) |
| A Multi-center Phase III Randomized Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma [NCT03836014] | Phase 3 | 436 participants (Actual) | Interventional | 2019-07-25 | Active, not recruiting |
| Effect of Dexamethasone on Reduction of Macular Thickness in Diabetic Patients, a Randomized Clinical Trial [NCT03608839] | Phase 2 | 27 participants (Actual) | Interventional | 2016-05-01 | Completed |
| Probiotic Supplementation Reduces Gastrointestinal Symptoms During the Therapy and Improves Therapeutic Response in AL Amyloidosis: A Randomized Controlled Trial [NCT05776940] | Phase 3 | 116 participants (Anticipated) | Interventional | 2023-03-31 | Not yet recruiting |
| A Phase 2 Trial to Evaluate the Efficacy of Bortezomib, Cytarabine, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma [NCT02840539] | Phase 2 | 19 participants (Actual) | Interventional | 2016-10-11 | Completed |
| A Phase II Study of a Chemotherapy-Free Induction Regimen for Ph+ Acute Lymphoblastic Leukemia (ALL) Incorporating Inotuzumab Ozogamicin (InO) [NCT04747912] | Phase 2 | 25 participants (Anticipated) | Interventional | 2021-03-02 | Recruiting |
| A 12-month, Open-label, Multicenter, Phase 4 Study to Evaluate the Efficacy and Safety of OZURDEX® Implant 700 µg (Dexamethasone) on Patients With Macular Edema Secondary to Retinal Vein Occlusion in China (YANGTZE Study) [NCT03908307] | Phase 4 | 150 participants (Actual) | Interventional | 2019-07-25 | Completed |
| Pilot Study of Bortezomib/Dexamethasone (BD), Followed By Autologous Stem Cell Transplantation and Maintenance Bortezomib/Dexamethasone For the Initial Treatment of Monoclonal Immunoglobulin Deposition Disease (MIDD) Associated With Multiple Myeloma and A [NCT01383759] | | 20 participants (Actual) | Interventional | 2011-06-24 | Completed |
| A Phase 3, Randomized, Open-label, Parallel-controlled, Multi-center Study Comparing TJ202, Lenalidomide and Dexamethasone vs. Lenalidomide and Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 1 Prior Line of Tr [NCT03952091] | Phase 3 | 291 participants (Actual) | Interventional | 2019-03-27 | Active, not recruiting |
| Effect of Sitagliptin on Short-Term Metabolic Dysregulation of Oral Glucocorticoid Therapy [NCT01488279] | | 10 participants (Actual) | Interventional | 2012-09-30 | Completed |
| Does Perineural Dexamethasone Increase the Duration of an Ulnar Nerve Block When Controlling for Systemic Effects? A Randomised, Blinded, Placebo-controlled, Paired, Non-inferiority Trial in Healthy Volunteers. [NCT04817982] | Phase 2 | 16 participants (Actual) | Interventional | 2021-04-07 | Completed |
| Phase 4 Study of Optimal Dose of Haloperidol [NCT01639599] | | 150 participants (Actual) | Interventional | 2012-03-31 | Completed |
| Evaluation of Fosaprepitant's Effect on Drug Metabolism in Sarcoma Patients Receiving Ifosfamide-based Multi-day Chemotherapy Regimen [NCT01490060] | | 47 participants (Actual) | Interventional | 2012-05-31 | Completed |
| The Combination of High-dose Dexamethasone and Acetylcysteine as the Treatment of Newly-diagnosed Immune Thrombocytopenia: A Single-arm, Open-label Trial [NCT04368598] | Phase 2 | 44 participants (Anticipated) | Interventional | 2019-04-01 | Recruiting |
| Treatment of Rotator Cuff Syndrome and Bursitis: A Double Blind, Controlled Trial to Assess the Efficacy and Safety of Traumeel® S Injection Versus Corticosteroid Injections and Versus Placebo [NCT01702233] | Phase 3 | 175 participants (Actual) | Interventional | 2013-04-30 | Completed |
| A Study of Therapy for Pediatric Relapsed or Refractory Acute Lymphoblastic Leukemia [NCT00186875] | Phase 2 | 47 participants (Actual) | Interventional | 2003-11-30 | Completed |
| Randomized Phase 2 Trial of Retreatment With Pomalidomide or Lenalidomide With Dexamethasone for Patients With Relapsed Myeloma [NCT01794039] | Phase 2 | 9 participants (Actual) | Interventional | 2014-03-31 | Completed |
| Dexamethasone Versus Dexmedetomidine as Local Anesthetic Adjuvants in Ultrasound Guided Transversus Abdominis Plane Block for Total Abdominal Hysterectomies [NCT03064633] | Phase 4 | 54 participants (Actual) | Interventional | 2017-03-08 | Completed |
| Comparison of Dexmedetomidine and Dexamethasone as Adjuvant to Bupivacaine in Ultrasound-guided Bilevel Erector Spinae Plane Block in Modified Radical Mastectomy [NCT05591417] | | 60 participants (Anticipated) | Interventional | 2022-10-27 | Recruiting |
| The Effect of Dilution With Glucose and Prolonged Injection Time on Dexamethasone-induced Perineal Irritation [NCT04950049] | | 200 participants (Anticipated) | Interventional | 2021-07-15 | Not yet recruiting |
| Transverse Abdominis Plane Block Using Liposomal Bupivacaine for Post-operative Cesarean Delivery Analgesia- Walking Towards Recovery [NCT04393207] | Phase 4 | 300 participants (Anticipated) | Interventional | 2022-02-01 | Recruiting |
| Slow-Go Strategy for High Risk AL Amyloidosis: Isatuximab for Upfront Therapy [NCT04754945] | Phase 1 | 25 participants (Anticipated) | Interventional | 2021-04-28 | Recruiting |
| Efficacy of Dexamethasone in Treatment of Meconium Aspiration Syndrome [NCT05517499] | | 120 participants (Actual) | Interventional | 2021-01-01 | Completed |
| Randomized Phase II Study of Bortezomib, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Elderly Patients With Newly Diagnosed Multiple Myeloma [NCT04277845] | Phase 2 | 49 participants (Actual) | Interventional | 2020-08-06 | Active, not recruiting |
| Phase I Trial of Pomalidomide for Patients With Relapsed/Refractory Primary CNS Lymphoma and Primary Vitreoretinal Lymphoma [NCT01722305] | Phase 1 | 29 participants (Actual) | Interventional | 2013-04-08 | Completed |
| Preoperative Radiosurgery for Brain Metastases Planned for Surgical Resection: A Two Arm Pilot Study [NCT04895592] | Early Phase 1 | 20 participants (Anticipated) | Interventional | 2021-07-20 | Recruiting |
| A Phase 1 Multi-Center, Open-Label, Dose-Escalation Study to Determine the Pharmacokinetics and Safety of Pomalidomide When Given in Combination With Low Dose Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma and Impaired Renal Functi [NCT01575925] | Phase 1 | 25 participants (Actual) | Interventional | 2012-06-01 | Completed |
| Transforaminal Epidural Steroid Injection to Treat Hemiplegic Shoulder Pain : A Randomized, Sham-Controlled, Proof of Principle Trial [NCT01572285] | | 20 participants (Anticipated) | Interventional | 2011-10-31 | Recruiting |
| A Phase II Investigation of Vorinostat in Combination With Intravenous Fludarabine, Mitoxantrone, and Dexamethasone in Patients With Relapsed or Refractory Mantle Cell Lymphoma [NCT01578343] | Phase 2 | 20 participants (Actual) | Interventional | 2012-06-30 | Terminated(stopped due to we collected data of a total of 19 patients for an interim analysis. but there are less than 7 responses out of the initial 19 patients.) |
| Comparison of the Effects of Palonosetron + Dexamethazone, Ondansetron + Dexamethazone and Dexametazone Alone Against Postoperative Nausea and Vomiting in Pediatric Patients Undergoing Laparoscopic Surgery [NCT05439798] | Phase 3 | 66 participants (Anticipated) | Interventional | 2022-06-01 | Enrolling by invitation |
| A Phase II Trial of the Immunomodulatory Drug CC-5013 for Patients With AL Amyloidosis [NCT00091260] | Phase 2 | 82 participants (Actual) | Interventional | 2004-01-31 | Completed |
| A Phase II Study of the Combination Bortezomib (Velcade, PS-341), Dexamethasone, and Rituximab in Patients With Waldenstroms Macroglobulinemia [NCT00250926] | Phase 2 | 23 participants (Actual) | Interventional | 2005-10-31 | Completed |
| Diagnosing Natriuretic Peptide Deficiency: A Pilot Study [NCT03035929] | Phase 1 | 10 participants (Actual) | Interventional | 2017-01-01 | Completed |
| Evaluation of Anti-inflammatory Steroids of Use in the Prevention of Tooth Sensitivity in Teeth Whitening Technique Office [NCT02956070] | | 70 participants (Actual) | Interventional | 2015-10-31 | Completed |
| Pharmacokinetics Study to Measure Plasma Concentrations of Dexamethasone Following EryDex (Dexamethasone Sodium Phosphate Encapsulated in Autologous Erythrocytes) Infusion in Healthy Volunteers [NCT01925859] | Phase 1 | 18 participants (Actual) | Interventional | 2013-06-30 | Completed |
| Phase II Trial Investigating Tailoring First-Line Therapy For Advanced Stage Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Mid-Treatment Positron Emission Tomography (PET) Scan Results [NCT00324467] | Phase 2 | 150 participants (Actual) | Interventional | 2006-08-31 | Active, not recruiting |
| Pilot Study of Standard Therapy for Prevention of Nausea and Emesis Associated With First Line Post-Operative Intraperitoneal Chemotherapy [NCT01275664] | | 4 participants (Actual) | Interventional | 2011-06-30 | Terminated(stopped due to Study terminated due to no patient population available) |
| Effect of Low-Dose Dexamethasone on the Incidence of Hyperglycemia Following Surgery [NCT01545700] | Phase 4 | 200 participants (Actual) | Interventional | 2009-09-30 | Completed |
| Aqueous Humour Concentrations After Topical apPlication of combinEd Levofloxacin-dexamethasone Eye dRops and of Its Single Components: a randoMized, assEssor-blinded, Parallel-group Study in Patients Undergoing Cataract Surgery - iPERME [NCT03740659] | Phase 2 | 125 participants (Actual) | Interventional | 2018-09-04 | Completed |
| Fascia Iliaca Block Supplemented With Perineural Vs Intravenous Dexamethasone: Effect On Post-Operative Pain In Children Undergoing Split Thickness Skin Grafting. [NCT04561856] | Phase 4 | 99 participants (Anticipated) | Interventional | 2020-09-30 | Not yet recruiting |
| Double Blind Prospective Study of IV Steroids Versus Steroids Included in Block for Orthopedic Lower Limb Surgery [NCT03855059] | Early Phase 1 | 50 participants (Actual) | Interventional | 2019-06-05 | Completed |
| A Phase II Study of 12-O-tetradecanoylphorbol-13-acetate (TPA) Plus Dexamethasone & Choline Magnesium Trisalicylate in the Treatment of Patients With Relapsed/Refractory Acute Myelogenous Leukemia [NCT01009931] | Phase 2 | 1 participants (Actual) | Interventional | 2011-03-31 | Terminated(stopped due to Study was terminated early due to lack of experimental medication (supply issues)) |
| Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture [NCT02421419] | Phase 4 | 26 participants (Actual) | Interventional | 2015-06-30 | Terminated(stopped due to Study closed; recruitment problems) |
| Fosaprepitant , Tropisetron and Olanzapine for the Prevention of Nausea and Vomiting in Patients With Breast Cancer Receiving Anthracycline/Cyclophosphamide-containing Chemotherapy [NCT05242874] | Phase 3 | 403 participants (Anticipated) | Interventional | 2022-01-01 | Recruiting |
| A Phase II Study of Sequential Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD] Therapy for Subjects With Newly Diagnosed Multiple Myeloma [NCT01559935] | Phase 2 | 74 participants (Actual) | Interventional | 2012-03-31 | Active, not recruiting |
| Spinal Versus General Anesthesia With Popliteal and Adductor Canal Blocks for Ambulatory Foot and Ankle Surgery: A Double-Blinded Randomized Controlled Trial. [NCT02996591] | Phase 4 | 36 participants (Actual) | Interventional | 2017-01-31 | Completed |
| Suitability of Periarticular Steroid Injections for Sickle Cell Arthropathy Pain Therapy [NCT05983055] | | 50 participants (Anticipated) | Observational | 2018-01-30 | Recruiting |
| Effect of Continuous Paravertebral Nerve Block Combined With Dexamethasone Palpitate vs Combined With Dexamethasone Sodium Phosphate on Chronic Postoperative Pain in Patients Undergoing Minimally Invasive Cardiac Surgery [NCT05920967] | | 902 participants (Anticipated) | Interventional | 2023-07-11 | Recruiting |
| Randomized Phase 1 / 2 Trial of Belantamab Mafodotin, Lenalidomide, and Daratumumab in Relapsed or Newly Diagnosed Multiple Myeloma Patients [NCT04892264] | Phase 1/Phase 2 | 5 participants (Actual) | Interventional | 2021-06-03 | Active, not recruiting |
| A Phase 1b Study of REOLYSIN® (Reovirus Serotype 3 - Dearing Strain) Combined With Standard Doses of Bortezomib and Dexamethasone in Patients With Relapsed/Refractory Multiple Myeloma [NCT02514382] | Phase 1 | 14 participants (Actual) | Interventional | 2015-08-21 | Completed |
| A Randomized, Double-Blind Trial to Compare the Clinical Efficacy and Safety of Granisetron vs. Metoclopramide Combined to Dexamethasone in the Prophylaxis of Chemotherapy-Induced Delayed Emesis [NCT00003213] | Phase 3 | 267 participants (Actual) | Interventional | 1996-05-31 | Completed |
| Assessing the Efficacy and Safety fo DEXTENZA, Sustained Release Dexamethasone 0.4 mg Insert(s) When Placed Within the Lower Eye Lid Canaliculus or Both the Upper and Lower Canaliculi for the Treatment of Pain, Inflammation, and Cystoid Macular Edema Foll [NCT04501367] | Phase 4 | 60 participants (Anticipated) | Interventional | 2021-04-27 | Recruiting |
| Post-operative Methylprednisolone Taper Course for Orthopedic Surgery [NCT03661645] | Phase 4 | 1,000 participants (Anticipated) | Interventional | 2018-09-07 | Enrolling by invitation |
| A Phase I Dose Escalation Study of Hydroxychloroquine With Infusional Cyclophosphamide, Pulse Dexamethasone and Rapamycin in Patients With Relapsed or Refractory Multiple Myeloma [NCT01689987] | Phase 1 | 18 participants (Actual) | Interventional | 2012-09-30 | Completed |
| Phase I/II Double Blind Randomized Trial of Lenalidomide/Dexamethasone/Anakinra vs. Lenalidomide/Dexamethasone/Placebo in Patients With Early Stage Multiple Myeloma and High Plasma Cell Growth Rate [NCT02492750] | Phase 1 | 14 participants (Actual) | Interventional | 2016-04-30 | Completed |
| A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of Rovalpituzumab Tesirine as Maintenance Therapy Following First-Line Platinum-Based Chemotherapy in Subjects With Extensive Stage Small Cell Lung Cancer (MERU) [NCT03033511] | Phase 3 | 748 participants (Actual) | Interventional | 2017-02-07 | Terminated(stopped due to Independent Data Monitoring Committee recommendation) |
| Allogeneic Stem Cell Transplantation vs. Conventional Therapy as Salvage Therapy for Relapsed / Progressive Patients With Multiple Myeloma After First-line Therapy [NCT05675319] | Phase 3 | 482 participants (Anticipated) | Interventional | 2023-03-03 | Recruiting |
| Evaluating Mechanisms of Immunomodulator Sensitivity and Resistance in Multiple Myeloma [NCT05288062] | Phase 2 | 190 participants (Anticipated) | Interventional | 2022-03-22 | Recruiting |
| A Phase I/II Study of Carfilzomib, Lenalidomide, Vorinostat, and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma [NCT01297764] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2011-04-30 | Active, not recruiting |
| Dose Escalation of Dexamethasone to Increase Duration of Transversus Abdominal Plane Block Following Cesarean Section: A Prospective Randomized Double-Blinded Clinical Study [NCT03098420] | Phase 2/Phase 3 | 29 participants (Actual) | Interventional | 2016-07-31 | Terminated(stopped due to Low enrollment; recruitment challenges due to competing studies in women and infant center) |
| Phase 2a Single-Arm Safety Study of Elotuzumab in Combination With Thalidomide and Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma [NCT01632150] | Phase 2 | 51 participants (Actual) | Interventional | 2012-05-31 | Completed |
| A Phase 3, Randomized, Double-blind, Placebo- and Active-controlled Study to Evaluate the Efficacy and Safety of TLC599 in Patients With Osteoarthritis of the Knee [NCT04123561] | Phase 3 | 506 participants (Actual) | Interventional | 2019-11-26 | Completed |
| A Phase 1B/2 Multi-Center, Open Label, Dose-Escalation Study to Determine the Maximum Tolerated Dose, Safety, and Efficacy of ACY-1215 (RICOLINOSTAT) in Combination With Pomalidomide and Low-Dose Dexamethasone in Patients With Relapsed and Refractory Mult [NCT01997840] | Phase 1/Phase 2 | 103 participants (Actual) | Interventional | 2014-03-01 | Active, not recruiting |
| A Phase I/II Trial of Pomalidomide and Dexamethasone in Subjects With Previously-Treated AL Amyloidosis [NCT01570387] | Phase 1/Phase 2 | 27 participants (Actual) | Interventional | 2012-06-30 | Completed |
| A Phase 2, Randomized Study of VELCADE® (Bortezomib), Dexamethasone, and Thalidomide Versus VELCADE® (Bortezomib), Dexamethasone, Thalidomide, and Cyclophosphamide in Subjects With Previously Untreated Multiple Myeloma Who Are Candidates for Autologous Tr [NCT00531453] | Phase 2 | 98 participants (Actual) | Interventional | 2007-10-31 | Completed |
| Perineural Versus Systemic Dexamethasone as an Analgesic Adjunct to Ultrasound-Guided Ropivacaine Interscalene Blockade in Arthroscopic Rotator Cuff Repair [NCT01450007] | Phase 4 | 130 participants (Actual) | Interventional | 2012-05-31 | Completed |
| A Randomized Comparison Between Perineural Dexamethasone and Perineural Mixture of Dexamethasone-Dexmedetomidine as Adjuvants for Ultrasound-Guided Infraclavicular Block [NCT04875039] | Phase 4 | 50 participants (Actual) | Interventional | 2021-08-31 | Completed |
| A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Efficacy and Safety of a Single 150 mg Dose of Intravenous Fosaprepitant Dimeglumine for the Prevention [NCT01594749] | Phase 3 | 1,015 participants (Actual) | Interventional | 2012-09-24 | Completed |
| A Randomized, Pilot Study of the Efficacy and Safety of Ozurdex Steroid Implants in Post-Vitrectomized Eyes in Patients With Diabetic Macular Edema [NCT01788475] | | 3 participants (Actual) | Interventional | 2013-02-22 | Terminated(stopped due to Study withdrawn by Investigator) |
| A Phase II Study of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed MCL [NCT03232307] | Phase 2 | 0 participants (Actual) | Interventional | 2019-07-01 | Withdrawn(stopped due to Sponsor does not wish to proceed) |
| Study of the Excretion of Orally Administered Corticosteroids for the Improval of the Detection of Said Substances in Anti-doping Controls [NCT04791345] | Phase 1 | 50 participants (Anticipated) | Interventional | 2021-02-26 | Recruiting |
| B-cell Mature Non-Hodgkin's Lymphoma Treatment Protocol in Children and Adolescents 2021 (B-NHL-M-2021) [NCT05518383] | Phase 4 | 300 participants (Anticipated) | Interventional | 2022-05-25 | Recruiting |
| Dexamethasone Preoperative for Patients Undergoing Laparoscopy for Suspected Appendicitis [NCT02415335] | Phase 2 | 119 participants (Actual) | Interventional | 2015-04-30 | Completed |
| Dexamethasone, Can it Replace Ketoprofen in the Strategy of Intraoperative Multimodal Analgesia in Paediatric Surgery ? A Prospective Randomized Double-blinded Study. DEXA OP [NCT02400047] | Phase 3 | 580 participants (Actual) | Interventional | 2015-06-03 | Completed |
| The Use of Perioperative Steroids in Patients Undergoing Transsphenoidal Resection of Pituitary Tumors or Cysts [NCT02084134] | | 43 participants (Actual) | Interventional | 2012-03-31 | Completed |
| A Phase 2 Study of Daratumumab, Bortezomib, and Dexamethasone (DVd), Followed by Daratumumab, Ixazomib, and Dexamethasone (DId) for Relapsed and/or Refractory Myeloma [NCT03763162] | Phase 2 | 60 participants (Anticipated) | Interventional | 2019-01-17 | Recruiting |
| The Effects of Auricular Acupressure on Chemotherapy-Induced Nausea and Vomiting in Female Breast Cancer Patients: A Pilot Randomized Controlled Trial [NCT02403037] | | 114 participants (Actual) | Interventional | 2015-07-31 | Completed |
| A Phase II, Open-label, Single Center Study of Ultra-High Dose Dexamethasone (UHDD) Administered Intravenously and Orally as Monotherapy for the Treatment of Relapsed Multiple Myeloma [NCT02402725] | Phase 2 | 0 participants (Actual) | Interventional | 2015-05-31 | Withdrawn(stopped due to poor accrual) |
| Selinexor(ATG-010) Plus Bortezomib, Lenalidomide and Dexamethasone (XVRd) in High Risk Newly Diagnosed Multiple Myeloma [NCT05422027] | Phase 1/Phase 2 | 42 participants (Anticipated) | Interventional | 2022-07-25 | Recruiting |
| A Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical and Anti-Microbial Efficacy and Safety of AzaSite Plus Compared to AzaSite Alone and Dexamethasone Alone in the Treatment of Subjects With Blepharoconjunctivitis [NCT00754949] | Phase 3 | 0 participants (Actual) | Interventional | | Withdrawn |
| Combined Intravenous Dexamethasone and Dexmedetomidine as Adjuncts to Popliteal and Saphenous Nerve Blocks in Patients Undergoing Orthopaedic Surgery of the Foot and Ankle. A Randomised, Blinded, Placebo-controlled, Parallel Clinical Trial [NCT04818749] | Phase 4 | 120 participants (Actual) | Interventional | 2021-06-02 | Completed |
| Iberdomide in Intermediate- and High-Risk Smoldering Myeloma (SMM) Patients: A Phase 2 Study With a Safety Run-in [NCT04776395] | Phase 2 | 68 participants (Anticipated) | Interventional | 2021-08-01 | Recruiting |
| A Phase I/II Study of Pomalidomide and Dexamethasone With Growth Factor Support in Patients With Relapsed/Refractory Multiple Myeloma [NCT01946152] | Phase 1/Phase 2 | 21 participants (Actual) | Interventional | 2014-03-05 | Terminated(stopped due to Per PI at time of CR) |
| Intravenous Versus Oral Regimens of Dexamethasone for Prophylaxis of Paclitaxel-associated Hypersensitivity Reaction in Primary Ovarian, Fallopian Tube and Peritoneal Cancer Patients: a Double-blind Randomized Controlled Trial [NCT02349763] | Phase 3 | 260 participants (Actual) | Interventional | 2015-02-28 | Completed |
| Open Label, Phase 2, Single-Arm Study of Selinexor, Daratumumab, Carfilzomib and Dexamethasone for High-Risk, Relapsed and Relapsed/Refractory Multiple Myeloma Patients Who Have Received 1 - 3 Prior Lines of Therapy [NCT04756401] | Phase 2 | 52 participants (Anticipated) | Interventional | 2022-12-08 | Recruiting |
| Effective Quadruplet Utilization After Treatment Evaluation (EQUATE): A Randomized Phase 3 Trial for Newly Diagnosed Multiple Myeloma Not Intended for Early Autologous Transplantation [NCT04566328] | Phase 3 | 1,450 participants (Anticipated) | Interventional | 2021-02-24 | Recruiting |
| Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM) [NCT03937635] | Phase 3 | 288 participants (Anticipated) | Interventional | 2019-09-16 | Recruiting |
| Phase 2 Trial of Ixazomib, Lenalidomide, Dexamethasone, and Daratumumab in Patients With Newly Diagnosed Multiple Myeloma [NCT03012880] | Phase 2 | 80 participants (Actual) | Interventional | 2017-04-12 | Active, not recruiting |
| Haloperidol Compared to Dexamethasone in Lowering Postoperative Nausea and Vomiting and Pain in Adult After Laparoscopy [NCT05246631] | Phase 4 | 80 participants (Actual) | Interventional | 2020-01-01 | Completed |
| REsponse Adapted Combination Therapy Approaches for High-Risk Multiple Myeloma (REACH) [NCT05497804] | Phase 2 | 75 participants (Anticipated) | Interventional | 2022-09-22 | Recruiting |
| [NCT00168298] | Phase 3 | 668 participants (Actual) | Interventional | 2004-11-01 | Completed |
| Dexmedetomidine Versus Dexamethasone Adding to Ondansetron for Prophylaxis Against Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy [NCT06017167] | Phase 2 | 70 participants (Anticipated) | Interventional | 2022-09-15 | Recruiting |
| An Open-Label Phase 1/2 Multi-Arm Study of DS-1594b as a Single-Agent and in Combination With Azacitidine and Venetoclax or Mini-HCVD for the Treatment of Patients With Acute Myeloid Leukemia (AML) and Acute Lymphoblastic Leukemia (ALL) [NCT04752163] | Phase 1/Phase 2 | 17 participants (Actual) | Interventional | 2021-03-25 | Completed |
| Iontophoresis With Dexamethasone in Combination With Physical Therapy for the Treatment of Pediatric Patients Diagnosed With Apophysitis of the Knee: A Randomized, Double-Blind, Placebo-Controlled Trial [NCT03606980] | Phase 2 | 46 participants (Actual) | Interventional | 2018-11-05 | Completed |
| A Randomized Controlled Trial to Evaluate a Novel Analgesia Technique for ACL Reconstruction: Adductor Canal Block With an IPACK Versus Adductor Canal Block [NCT03292926] | Phase 4 | 78 participants (Actual) | Interventional | 2017-10-04 | Active, not recruiting |
| [NCT00333814] | Phase 2/Phase 3 | 229 participants (Actual) | Interventional | 2006-05-31 | Completed |
| Dose/Schedule Finding Study of Palonosetron in Sarcoma Patients Receiving Multi-Day Chemotherapy With Adriamycin and Ifosfamide (AI) [NCT00410488] | | 51 participants (Actual) | Interventional | 2006-12-31 | Completed |
| LS1781: Phase 2 Trial of High Dose Intravenous Ascorbic Acid as an Adjunct to Salvage Chemotherapy in Relapsed / Refractory Lymphoma and Patients With Clonal Cytopenia of Undetermined Significance [NCT03418038] | Phase 2 | 55 participants (Anticipated) | Interventional | 2018-03-23 | Recruiting |
| A Phase III Randomized Trial for Newly Diagnosed High Risk B-Lymphoblastic Leukemia (B-ALL) Including a Stratum Evaluating Dasatinib (NSC#732517) in Patients With Ph-like Tyrosine Kinase Inhibitor (TKI) Sensitive Mutations [NCT02883049] | Phase 3 | 5,937 participants (Actual) | Interventional | 2012-02-29 | Active, not recruiting |
| A Phase II Randomized Study Comparing Two Doses of Carfilzomib (NSC-756640) With Dexamethasone for Multiple Myeloma Patients With Relapsed or Refractory Disease [NCT01903811] | Phase 2 | 143 participants (Actual) | Interventional | 2013-10-31 | Completed |
| A Pivotal, Double-Masked, Randomized, 2-stage, Multicenter Study of the Efficacy and Safety of OCS-01 Eye Drops in Subjects With Diabetic Macular Edema [NCT05066997] | Phase 2/Phase 3 | 497 participants (Anticipated) | Interventional | 2021-10-19 | Active, not recruiting |
| The Combination of High-dose Dexamethasone and Tacrolimus Versus High-dose Dexamethasone as the First-Line Treatment of Newly-diagnosed Immune Thrombocytopenia: A Randomized, Controlled, Multicenter, Open-label Trial [NCT04747080] | Phase 2 | 120 participants (Anticipated) | Interventional | 2021-03-01 | Recruiting |
| DEXTENZA for the Treatment of Pain and Inflammation Following Surgical Trabeculectomy and Ahmed Valve Procedures [NCT05116345] | Phase 4 | 30 participants (Anticipated) | Interventional | 2021-11-30 | Not yet recruiting |
| The Relapse From MRD Negativity as Indication for Treatment (REMNANT) Study [NCT04513639] | Phase 2/Phase 3 | 176 participants (Anticipated) | Interventional | 2020-08-27 | Recruiting |
| The Postoperative Analgesic Effect of Dexamethasone Added to Topical Bupivacaine in Endoscopic Nasal Surgery [NCT03036605] | Phase 4 | 60 participants (Actual) | Interventional | 2017-03-15 | Completed |
| Analgesia After Total Knee Arthroplasty: Adductor Canal Block With Periarticular Injection and IPACK (ACB/PAI/IPACK) Versus Periarticular Injection (PAI). A Double-Blinded Randomized Controlled Trial [NCT03094663] | | 86 participants (Anticipated) | Interventional | 2017-02-28 | Recruiting |
| A Randomized Study to Determine the Efficacy and Tolerability of Olanzapine for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients [NCT03079219] | Phase 3 | 120 participants (Actual) | Interventional | 2017-03-23 | Completed |
| Empliciti® (Elotuzumab) Post-Marketing Surveillance Study for Patients With Multiple Myeloma in Taiwan [NCT06163040] | | 27 participants (Anticipated) | Observational | 2023-11-30 | Not yet recruiting |
| Evaluation of Lacrimal Punctal Changes by Anterior Segment Optical Coherence Tomography AS-OCT After Topical Combined Antibiotics and Steroids Treatment in Cases of Inflammatory Punctual Stenosis [NCT05028907] | Phase 4 | 64 participants (Actual) | Interventional | 2020-11-15 | Completed |
| Evaluation of Cortisol Resistance in Young Sedentary and Endurance-trained Men and Elderly Sedentary Men [NCT01294319] | Phase 2 | 51 participants (Actual) | Interventional | 2011-01-24 | Completed |
| Comparison of the Effects of Perineural Versus Systemic Dexamethasone on Low Dose Interscalene Brachial Plexus Block: A Randomized Control Trial [NCT02322242] | Phase 4 | 182 participants (Actual) | Interventional | 2015-01-31 | Completed |
| A Phase 1 Study of Amrubicin in Combination With Lenalidomide and Weekly Dexamethasone in Relapsed/Refractory Multiple Myeloma [NCT01355705] | Phase 1/Phase 2 | 14 participants (Actual) | Interventional | 2011-08-31 | Completed |
| Duration of Analgesia After Popliteal Fossa Nerve Blockade: Effects of Dexamethasone and Buprenorphine [NCT01277159] | | 108 participants (Actual) | Interventional | 2010-10-31 | Completed |
| Efficacy, Safety and Feasibility of Fosaprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting in Pediatric Patients With Solid Tumors Receiving Moderately and Highly Emetogenic Chemotherapy [NCT04508400] | Phase 2 | 108 participants (Anticipated) | Interventional | 2021-09-01 | Not yet recruiting |
| A Multi-Centre Randomised Study Comparing Tapering Low Dose Dexamethasone to Other Standard of Care Therapies for Taxane- Associated Pain Syndrome (TAPS) in Breast Cancer Patients (OTT 17-02 REaCT-TAPS) [NCT03348696] | Phase 4 | 124 participants (Actual) | Interventional | 2018-02-28 | Completed |
| Does Low Dose of Dexamethasone Enhance Analgesic Quality of Caudal Analgesia in Children Undergoing Orchiopexy? [NCT04841018] | | 273 participants (Actual) | Interventional | 2021-03-24 | Completed |
| A Phase 3 Randomized Trial of Inotuzumab Ozogamicin (NSC#: 772518) for Newly Diagnosed High-Risk B-ALL; Risk-Adapted Post-Induction Therapy for High-Risk B-ALL, Mixed Phenotype Acute Leukemia, and Disseminated B-LLy [NCT03959085] | Phase 3 | 4,772 participants (Anticipated) | Interventional | 2019-10-31 | Recruiting |
| LIMBO-ATX: Lower-Limb Adventitial Infusion of DexaMethasone Via Bullfrog to Reduce Occurrence of Restenosis After Atherectomy (ATX)-Based Revascularization [NCT02479620] | Phase 2 | 120 participants (Anticipated) | Interventional | 2016-06-30 | Active, not recruiting |
| Phase II Open Label Study for the Assessment of the Efficacy and Safety of Lenalidomide & Adriamycin & Low Dose Dexamethasone (RAD) in Newly Diagnosed, Symptomatic Multiple Myeloma Patients [NCT02471820] | Phase 2 | 45 participants (Actual) | Interventional | 2014-11-30 | Completed |
| Impact of the Use of Nandrolone on the Treatment of Malnutrition Induced by Cancer [NCT03263520] | | 60 participants (Actual) | Interventional | 2016-02-29 | Completed |
| A Phase I De-Escalation Study of Dexamethasone With Azeliragon for Management of Post-Resection Cerebral Edema in Patients With Glioblastoma [NCT05773664] | Phase 1 | 21 participants (Anticipated) | Interventional | 2023-12-15 | Not yet recruiting |
| A Phase 2 Study of Weekly 70 mg/m2 Carfilzomib for Multiple Myeloma Patients Refractory to 27 mg/m2 Carfilzomib [NCT02294357] | Phase 2 | 45 participants (Anticipated) | Interventional | 2014-12-31 | Terminated(stopped due to Early termination due to the difficulties to enroll subjects.) |
| Impact of Duloxetine and Dexamethasone for Improving Postoperative Pain After Laparoscopic Gynecological Surgeries: a Randomized Clinical Trial [NCT03250494] | Phase 4 | 75 participants (Actual) | Interventional | 2014-12-31 | Completed |
| Phase I Dose-Escalation and Dose-Expansion Trial of a Novel Glutaminase Inhibitor (CB-839 HCl) in Combination With Carfilzomib and Dexamethasone in Relapsed and/or Refractory Multiple Myeloma [NCT03798678] | Phase 1 | 36 participants (Anticipated) | Interventional | 2019-07-08 | Active, not recruiting |
| Cervical Transforaminal Injection of Steroids Guided by Ultrasound [NCT02295709] | | 60 participants (Anticipated) | Interventional | 2014-01-31 | Active, not recruiting |
| The ESCRS EPICAT Study: Effectiveness of Periocular Drug Injection in CATaract Surgery [NCT05158699] | Phase 3 | 808 participants (Anticipated) | Interventional | 2021-10-13 | Recruiting |
| Steroid Therapy in Acute Bronchiolitis A New Old Line of Therapy. [NCT03436225] | Phase 1 | 80 participants (Anticipated) | Interventional | 2019-02-28 | Not yet recruiting |
| Phase 3, Randomized, Open Label Trial of Lenalidomide/Dexamethasone With or Without Elotuzumab in Relapsed or Refractory Multiple Myeloma (MM) [NCT01239797] | Phase 3 | 646 participants (Actual) | Interventional | 2011-06-20 | Completed |
| Effects of Rolapitant on Nausea/Vomiting in Patients With Sarcoma Receiving Multi-Day Highly Emetogenic Chemotherapy (HEC) With Doxorubicin and Ifosfamide Regimen (AI) [NCT02732015] | Phase 2 | 37 participants (Actual) | Interventional | 2016-10-12 | Terminated(stopped due to Terminated per PI's request) |
| Study of Serum Measured Folate Receptor and Its Induction as a Biomarker in the Diagnosis and Surveillance of Ovarian Carcinoma [NCT02520115] | Phase 1 | 50 participants (Actual) | Interventional | 2015-08-31 | Completed |
| Hormonal Mechanisms of Sleep Restriction - Axis Study in Older Men and Postmenopausal Women [NCT04037605] | Early Phase 1 | 5 participants (Actual) | Interventional | 2020-02-09 | Active, not recruiting |
| Phase I/II Study of the Combination of Low-Intensity Chemotherapy and Venetoclax (ABT-199) in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) [NCT03808610] | Phase 1/Phase 2 | 50 participants (Anticipated) | Interventional | 2019-04-03 | Recruiting |
| Ixazomib, Lenalidomide, and Dexamethasone for Patients With POEMS Syndrome [NCT02921893] | Early Phase 1 | 21 participants (Actual) | Interventional | 2016-10-31 | Active, not recruiting |
| The Function and Composition of B Cells in Participants With Glioblastoma Treated With and Without Dexamethasone [NCT04128774] | | 20 participants (Anticipated) | Observational | 2021-01-01 | Recruiting |
| The Impact of Preoperative Oral Dexamethasone Supplementation on the Biochemical Parameters and Results of Surgical Treatment in Patients With Nontoxic Multinodular Goiter Undergoing Total Thyroidectomy. [NCT04412694] | Phase 4 | 100 participants (Anticipated) | Interventional | 2020-07-01 | Recruiting |
| A Pilot Study of Decitabine and Vorinostat With Chemotherapy for Relapsed ALL [NCT01483690] | Phase 1/Phase 2 | 23 participants (Actual) | Interventional | 2011-12-31 | Terminated(stopped due to Toxicity) |
| Efficacy of an Intravitreal Dexamethasone Implant on Macular Function in Retinal Vein Occlusion Following Treatment With Intravitreal Anti-VEGF Injections. [NCT01449682] | Phase 3 | 10 participants (Actual) | Interventional | 2011-10-31 | Completed |
| A Safety Study of Daratumumab, Ixazomib, and Dexamethasone in AL Amyloidosis [NCT03283917] | Phase 1 | 21 participants (Actual) | Interventional | 2018-02-07 | Active, not recruiting |
| Perioperative Tonsillectomy Protocol Development for Preoperative Acetaminophen and Intraoperative High Dose Dexamethasone: a Randomized Control Trial [NCT03323047] | Phase 4 | 60 participants (Anticipated) | Interventional | 2018-03-01 | Recruiting |
| Open-label, Multli-center, Phase 1b/2a Clinical Trial Designed to Evaluate the Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution in Patients With Macular Edema [NCT02485249] | Phase 1/Phase 2 | 25 participants (Actual) | Interventional | 2015-07-31 | Terminated(stopped due to Slow enrollment) |
| Particulate vs. Nonparticulate Epidural Steroid Injections for the Treatment of Symptomatic Unilateral Lumbar Foraminal Stenosis: a Prospective Double-blinded Randomized Study [NCT03245671] | Phase 4 | 0 participants (Actual) | Interventional | 2017-12-31 | Withdrawn(stopped due to Unable to address regulatory concerns.) |
| Effects of a Triple Adjuvant Combination of Buprenorphine, Clonidine, and Dexamethasone on Duration of Brachial Plexus Blocks for Upper Extremity Surgery, a Prospective, Randomized Clinical Trial [NCT05824832] | Phase 4 | 120 participants (Anticipated) | Interventional | 2023-02-28 | Recruiting |
| A Randomized Trial Using a Modified COG ABFM Regimen Backbone to Investigate Capizzi Escalating Methotrexate Versus High Dose Methotrexate in Children With Newly Diagnosed T-cell Lymphoblastic Lymphoma (T-LBL) [NCT05681260] | Phase 3 | 200 participants (Anticipated) | Interventional | 2023-02-06 | Recruiting |
| Yale Steroid Enhanced Versus Exparel Nerveblock TKA Randomized Controlled Trial (RCT) Study [NCT05279092] | Phase 2 | 250 participants (Anticipated) | Interventional | 2022-09-08 | Recruiting |
| A Pilot Study of Dexamethasone Therapy Prior to Rechallenge With Enzalutamide in Men With Metastatic Castration-Resistant Prostate Cancer Dex EXTends Enza Response (The DEXTER Trial) [NCT02491411] | | 5 participants (Actual) | Interventional | 2015-09-30 | Terminated(stopped due to The study is terminated due to lower enrollment) |
| A Korean Multicenter, Randomized, Double-Blind, Clinical Trial to Evaluate the Efficacy and Tolerability of Aprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting in the First Cycle of Moderately Emetogenic Chemotherapies (MEC, Non-AC R [NCT01636947] | Phase 4 | 494 participants (Actual) | Interventional | 2012-12-12 | Completed |
| Augmented Berlin-Frankfurt-Munster Therapy Plus Ofatumumab for Young Adults With Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma [NCT02419469] | Phase 2 | 1 participants (Actual) | Interventional | 2015-11-13 | Terminated(stopped due to Slow Accrual) |
| Randomized Clinical Trial of Intranasal Dexamethasone as an Adjuvant in Patients With COVID-19 [NCT04513184] | Phase 2 | 66 participants (Actual) | Interventional | 2021-11-05 | Completed |
| A Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Comparative Efficacy and Safety of EXL CDOS in Subjects With Acute Otitis Externa [NCT02216071] | Phase 3 | 499 participants (Actual) | Interventional | 2014-07-20 | Completed |
| Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction [NCT01586806] | Phase 4 | 195 participants (Actual) | Interventional | 2012-07-31 | Completed |
| [information is prepared from clinicaltrials.gov, extracted Sep-2024] |
| Trial | Outcome |
|---|
| NCT00025259 (4) [back to overview] | Overall Survival |
| NCT00025259 (4) [back to overview] | Disease Response Assessed by Modified RECIST Criteria |
| NCT00025259 (4) [back to overview] | Event-free Survival |
| NCT00025259 (4) [back to overview] | Grade 3 or 4 Non-hematologic Toxicity |
| NCT00060944 (5) [back to overview] | Progression-Free Survival - Independent Review |
| NCT00060944 (5) [back to overview] | Overall Survival |
| NCT00060944 (5) [back to overview] | Duration of Response - Independent Review |
| NCT00060944 (5) [back to overview] | Percentage of Participants Objective Response - Independent Review |
| NCT00060944 (5) [back to overview] | Time to Progression- Independent Review |
| NCT00075725 (7) [back to overview] | Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions |
| NCT00075725 (7) [back to overview] | Correlation of Early Marrow Response Status With MRD Negative. |
| NCT00075725 (7) [back to overview] | Correlation of Early Marrow Response Status With MRD Positive. |
| NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS). |
| NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS). |
| NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS) |
| NCT00075725 (7) [back to overview] | Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS) |
| NCT00091260 (3) [back to overview] | Number of Patients With Hematologic Response With Single-agent CC-5013 |
| NCT00091260 (3) [back to overview] | Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response |
| NCT00091260 (3) [back to overview] | Number of Patients Removed From Study Treatment Due to Toxicities |
| NCT00098475 (2) [back to overview] | Proportion of Patients With Objective Response (First Phase, Step 1) |
| NCT00098475 (2) [back to overview] | Proportion of Patients With Objective Response (First Phase, Step 2) |
| NCT00103285 (10) [back to overview] | Event-free Survival (EFS) for SR-Low Patients |
| NCT00103285 (10) [back to overview] | Event-Free Survival Probability According to MRD Status End Induction (Day 29) |
| NCT00103285 (10) [back to overview] | Event-free Survival (EFS) for SR-Average ALL Patients |
| NCT00103285 (10) [back to overview] | Event-free Survival (EFS) for SR-Average ALL Patients |
| NCT00103285 (10) [back to overview] | Overall Survival Probability (OS) According to Induction Day 29 MRD Status |
| NCT00103285 (10) [back to overview] | Health-related Quality of Life Relative to Physical, Social and Emotional Impairment |
| NCT00103285 (10) [back to overview] | Optimal Time Point for Advance Health Related Quality of Life Intervention |
| NCT00103285 (10) [back to overview] | Event-free Survival (EFS) for SR-High Patients. |
| NCT00103285 (10) [back to overview] | Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative) |
| NCT00103285 (10) [back to overview] | Early Marrow Status (EMS) by MRD Status End Induction (Day 29) |
| NCT00168298 (4) [back to overview] | Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye |
| NCT00168298 (4) [back to overview] | Change From Baseline in Retinal Thickness in the Study Eye |
| NCT00168298 (4) [back to overview] | Percentage of Patients With a Change From Baseline in BCVA by Category |
| NCT00168298 (4) [back to overview] | Percentage of Patients With a Change From Baseline in BCVA by Category |
| NCT00168324 (5) [back to overview] | Percentage of Patients With a Change From Baseline in BCVA by Category |
| NCT00168324 (5) [back to overview] | Percentage of Patients With a Change From Baseline in BCVA by Category |
| NCT00168324 (5) [back to overview] | Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye |
| NCT00168324 (5) [back to overview] | Change From Baseline in Retinal Thickness in the Study Eye |
| NCT00168324 (5) [back to overview] | Cumulative Response Rate of 15 or More Letter Improvement |
| NCT00186875 (4) [back to overview] | Overall Survival (OS) |
| NCT00186875 (4) [back to overview] | Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111) |
| NCT00186875 (4) [back to overview] | Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111) |
| NCT00186875 (4) [back to overview] | Response Rate |
| NCT00250926 (4) [back to overview] | Number of Participants With Adverse Events |
| NCT00250926 (4) [back to overview] | Response Rate |
| NCT00250926 (4) [back to overview] | Time to Progression |
| NCT00250926 (4) [back to overview] | Time to Best Response |
| NCT00293384 (4) [back to overview] | Toxicity Grade 3, 4, or 5 |
| NCT00293384 (4) [back to overview] | Proportion of Participants With Controlled Acute Vomiting |
| NCT00293384 (4) [back to overview] | Overall Nausea Controlled |
| NCT00293384 (4) [back to overview] | Delayed Vomiting Controlled |
| NCT00333814 (3) [back to overview] | Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA) |
| NCT00333814 (3) [back to overview] | Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero |
| NCT00333814 (3) [back to overview] | Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score |
| NCT00335140 (1) [back to overview] | Complete Response Rate - Locally Reviewed |
| NCT00337727 (2) [back to overview] | Number of Patients Who Reported No Vomiting |
| NCT00337727 (2) [back to overview] | Number of Patients Who Reported Complete Response |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV) |
| NCT00408005 (8) [back to overview] | Cumulative Incidence of CNS Relapse for T-ALL by Risk Group |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV) |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV) |
| NCT00408005 (8) [back to overview] | Cumulative Incidence of CNS Relapse for T-ALL by Risk Group |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort |
| NCT00408005 (8) [back to overview] | Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV) |
| NCT00410488 (1) [back to overview] | Palonosetron Response Rate in the 10 Day Study Cycle |
| NCT00424047 (12) [back to overview] | Summary of Myeloma Response Rates Based on Best Response Assessment |
| NCT00424047 (12) [back to overview] | Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale (Later Cut-off Date of 02 March 2008) |
| NCT00424047 (12) [back to overview] | Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008) |
| NCT00424047 (12) [back to overview] | Time to First Symptomatic Skeletal-related Event (SRE) (Clinical Need for Radiation or Surgery to Bone) |
| NCT00424047 (12) [back to overview] | Time to First Worsening on the Eastern Cooperative Oncology Group (ECOG) Performance Scale |
| NCT00424047 (12) [back to overview] | Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008) |
| NCT00424047 (12) [back to overview] | Number of Participants With Adverse Events (AE) |
| NCT00424047 (12) [back to overview] | Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008) |
| NCT00424047 (12) [back to overview] | Kaplan-Meier Estimate of Time to Tumor Progression (TTP) |
| NCT00424047 (12) [back to overview] | Kaplan-Meier Estimate of Overall Survival (OS) |
| NCT00424047 (12) [back to overview] | Kaplan-Meier Estimate of Duration of Response (Cut-off at a Later Date of 03 March 2008) |
| NCT00424047 (12) [back to overview] | Kaplan-Meier Estimate of Duration of Response |
| NCT00445692 (2) [back to overview] | Time to Disease Progression |
| NCT00445692 (2) [back to overview] | Episodes of Grade 3-4 Non Infectious, Non-dermatological or Non-neurological Toxicities, Episodes of Any Infections, Grade 3-4 Dermatological or Episodes of Grade 2-3 Peripheral Neuropathy Common Terminology Criteria for Adverse Events Version 3 |
| NCT00477412 (4) [back to overview] | Time to Failure (Phase II) |
| NCT00477412 (4) [back to overview] | Overall Survival |
| NCT00477412 (4) [back to overview] | Number of Participants With Overall Response Rate |
| NCT00477412 (4) [back to overview] | Maximum Tolerated Dose of Bortezomib (Phase I) |
| NCT00520767 (3) [back to overview] | Overall Survival |
| NCT00520767 (3) [back to overview] | Time to Treatment Failure (TTF) |
| NCT00520767 (3) [back to overview] | Complete Hematologic Response |
| NCT00531453 (2) [back to overview] | Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction |
| NCT00531453 (2) [back to overview] | Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT) |
| NCT00549848 (6) [back to overview] | Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01% |
| NCT00549848 (6) [back to overview] | Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase. |
| NCT00549848 (6) [back to overview] | Probability of CNS Relapse |
| NCT00549848 (6) [back to overview] | Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5% |
| NCT00549848 (6) [back to overview] | Probability of Overall Survival |
| NCT00549848 (6) [back to overview] | Probability of Event-free Survival |
| NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2 |
| NCT00557193 (10) [back to overview] | Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm |
| NCT00557193 (10) [back to overview] | Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy |
| NCT00557193 (10) [back to overview] | Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00557193 (10) [back to overview] | Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00557193 (10) [back to overview] | Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00557193 (10) [back to overview] | Number of Patients Who Experienced Lestaurtinib-related Dose Limiting Toxicity (DLT) |
| NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) for Patients on Arm A |
| NCT00557193 (10) [back to overview] | Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2) |
| NCT00557193 (10) [back to overview] | Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts |
| NCT00560391 (10) [back to overview] | Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone |
| NCT00560391 (10) [back to overview] | Number of Participants With Minimal Response |
| NCT00560391 (10) [back to overview] | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus |
| NCT00560391 (10) [back to overview] | Number of Participants With Dose-limiting Toxicity (DLT) |
| NCT00560391 (10) [back to overview] | Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC) |
| NCT00560391 (10) [back to overview] | Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone) |
| NCT00560391 (10) [back to overview] | Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia |
| NCT00560391 (10) [back to overview] | Number of Participants With Complete Response and Very Good Partial Response |
| NCT00560391 (10) [back to overview] | Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation |
| NCT00560391 (10) [back to overview] | Number of Participants With Partial Response |
| NCT00608907 (1) [back to overview] | Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours |
| NCT00609518 (4) [back to overview] | Proportion of Participants With Best Overall Tumor Response (Response Rate) |
| NCT00609518 (4) [back to overview] | Safety: Number of Participants With Drug-Related Grade 3 or 4 Toxicity |
| NCT00609518 (4) [back to overview] | Overall Survival |
| NCT00609518 (4) [back to overview] | Progression-free Survival (PFS) |
| NCT00619359 (3) [back to overview] | No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin) |
| NCT00619359 (3) [back to overview] | A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin). |
| NCT00619359 (3) [back to overview] | A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin). |
| NCT00635154 (7) [back to overview] | Number of Patients Who Are Progression-free and Alive at 6 Months |
| NCT00635154 (7) [back to overview] | Progression Free Survival (PFS) in Patients Treated With Anakinra Alone or in Combination With Dexamethasone |
| NCT00635154 (7) [back to overview] | Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone |
| NCT00635154 (7) [back to overview] | Number of Patients With Severe Non-hematological Adverse Events in Patients Receiving Anakinra Alone or in Combination With Dexamethasone. |
| NCT00635154 (7) [back to overview] | Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone |
| NCT00635154 (7) [back to overview] | Number of Patients With Response to Treatment With Dexamethasone and Anakinra |
| NCT00635154 (7) [back to overview] | Duration of Response |
| NCT00644228 (3) [back to overview] | Overall Survival |
| NCT00644228 (3) [back to overview] | Response Rates () |
| NCT00644228 (3) [back to overview] | Progression-free Survival |
| NCT00651261 (5) [back to overview] | Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant |
| NCT00651261 (5) [back to overview] | Overall Survival (OS) |
| NCT00651261 (5) [back to overview] | Event- Free Survival |
| NCT00651261 (5) [back to overview] | Disease-free Survival (DFS) |
| NCT00651261 (5) [back to overview] | Complete Response Rate |
| NCT00663169 (7) [back to overview] | Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study |
| NCT00663169 (7) [back to overview] | ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period |
| NCT00663169 (7) [back to overview] | Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale |
| NCT00663169 (7) [back to overview] | Number of Patients Who Took Rescue Medication |
| NCT00663169 (7) [back to overview] | Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4 |
| NCT00663169 (7) [back to overview] | Change in C-reactive Protein (CRP) From Baseline at Month 4 |
| NCT00663169 (7) [back to overview] | Change From Baseline in Pain Using a Visual Analog Scale at Month 4 |
| NCT00671034 (9) [back to overview] | Percentage of Participants With Event-free Survival (EFS) |
| NCT00671034 (9) [back to overview] | Percentage of Participants With Complete Remission at the End of Induction |
| NCT00671034 (9) [back to overview] | Toxicities During Post Induction Intensification Therapy (All Grades) |
| NCT00671034 (9) [back to overview] | Plasma and CSF Concentrations of Asparagine in ug/ml |
| NCT00671034 (9) [back to overview] | Immunogenicity |
| NCT00671034 (9) [back to overview] | Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction |
| NCT00671034 (9) [back to overview] | Asparaginase Level |
| NCT00671034 (9) [back to overview] | Pharmacodynamics (PD) |
| NCT00671034 (9) [back to overview] | Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy) |
| NCT00689936 (43) [back to overview] | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale |
| NCT00689936 (43) [back to overview] | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale |
| NCT00689936 (43) [back to overview] | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale |
| NCT00689936 (43) [back to overview] | Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score |
| NCT00689936 (43) [back to overview] | Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase |
| NCT00689936 (43) [back to overview] | Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase |
| NCT00689936 (43) [back to overview] | Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase |
| NCT00689936 (43) [back to overview] | Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review |
| NCT00689936 (43) [back to overview] | Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT) |
| NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis |
| NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC |
| NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS) |
| NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis |
| NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Time to Treatment Failure (TTF) |
| NCT00689936 (43) [back to overview] | Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis |
| NCT00689936 (43) [back to overview] | Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis |
| NCT00689936 (43) [back to overview] | Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC) |
| NCT00689936 (43) [back to overview] | Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase. |
| NCT00689936 (43) [back to overview] | Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review. |
| NCT00689936 (43) [back to overview] | Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review |
| NCT00689936 (43) [back to overview] | Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review |
| NCT00689936 (43) [back to overview] | Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis |
| NCT00689936 (43) [back to overview] | Number of Participants With Adverse Events (AEs) During the Active Treatment Phase |
| NCT00689936 (43) [back to overview] | Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis |
| NCT00689936 (43) [back to overview] | Percentage of Participants With an Objective Response Based on IRAC Review |
| NCT00689936 (43) [back to overview] | Time to First Response Based on the Investigator Assessment at the Time of Final Analysis |
| NCT00689936 (43) [back to overview] | Time to First Response Based on the Review by the IRAC |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Constipation Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Fatigue Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Insomnia Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Pain Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain |
| NCT00689936 (43) [back to overview] | Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale |
| NCT00720109 (5) [back to overview] | Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy |
| NCT00720109 (5) [back to overview] | Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy |
| NCT00720109 (5) [back to overview] | Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events |
| NCT00720109 (5) [back to overview] | Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib) |
| NCT00720109 (5) [back to overview] | Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation |
| NCT00734929 (12) [back to overview] | Cumulative Incidence of Emesis |
| NCT00734929 (12) [back to overview] | "Number of Participants Who Rated Their Satisfaction With Antiemetic Management as Very Satisfied" |
| NCT00734929 (12) [back to overview] | Average Nausea Score |
| NCT00734929 (12) [back to overview] | Number of Participants With a Complete Response Rate |
| NCT00734929 (12) [back to overview] | Incidence of Nausea |
| NCT00734929 (12) [back to overview] | Use of Rescue Antiemetics (Post OP) |
| NCT00734929 (12) [back to overview] | Use of Rescue Antiemetics (48 Hours) |
| NCT00734929 (12) [back to overview] | Use of Rescue Antiemetics (24 Hours) |
| NCT00734929 (12) [back to overview] | Time to First Vomiting |
| NCT00734929 (12) [back to overview] | Number of Vomiting Episodes |
| NCT00734929 (12) [back to overview] | Incidence of Vomiting (Post OP) |
| NCT00734929 (12) [back to overview] | Incidence of Vomiting (24 Hours) |
| NCT00742560 (12) [back to overview] | Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1) |
| NCT00742560 (12) [back to overview] | Duration of Response |
| NCT00742560 (12) [back to overview] | Time to Progression (TTP) |
| NCT00742560 (12) [back to overview] | Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 1) |
| NCT00742560 (12) [back to overview] | Objective Response Rate (ORR) According to the International Myeloma Working Group Uniform Response Criteria (Phase 2) |
| NCT00742560 (12) [back to overview] | Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA) |
| NCT00742560 (12) [back to overview] | Progression-free Survival (PFS) |
| NCT00742560 (12) [back to overview] | Mean Serum Concentrations of Elotuzumab During Cycle 1 |
| NCT00742560 (12) [back to overview] | Mean Serum Concentrations of Elotuzumab During Cycle 1 |
| NCT00742560 (12) [back to overview] | Number of Participants With Infusion Reactions |
| NCT00742560 (12) [back to overview] | Number of Participants With Treatment-emergent Adverse Events (TEAEs) |
| NCT00742560 (12) [back to overview] | Plasma Cell Myeloma Cytogenetic Subtype |
| NCT00783367 (2) [back to overview] | Response Rate to Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphoma With Rituximab Resistance |
| NCT00783367 (2) [back to overview] | Time Until Progression After Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphomas With Rituximab Resistance |
| NCT00792948 (3) [back to overview] | Overall Survival (OS) |
| NCT00792948 (3) [back to overview] | Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation |
| NCT00792948 (3) [back to overview] | Continuous Complete Remission (CCR) Rate |
| NCT00806819 (14) [back to overview] | Progression Free Survival (PFS) as Assessed by Central Independent Review |
| NCT00806819 (14) [back to overview] | Overall Survival (Key Secondary Endpoint) |
| NCT00806819 (14) [back to overview] | Duration of Confirmed Objective Tumour Response |
| NCT00806819 (14) [back to overview] | Dose Normalised Predose Plasma Concentration at Steady State (Cpre,ss,Norm) of Nintedanib and of Its Metabolites BIBF 1202 and BIBF 1202 Glucuronide |
| NCT00806819 (14) [back to overview] | Disease Control |
| NCT00806819 (14) [back to overview] | Change From Baseline in Tumour Size |
| NCT00806819 (14) [back to overview] | Clinical Improvement. |
| NCT00806819 (14) [back to overview] | Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review |
| NCT00806819 (14) [back to overview] | Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator |
| NCT00806819 (14) [back to overview] | Incidence and Intensity of Adverse Events |
| NCT00806819 (14) [back to overview] | Time to Confirmed Objective Tumour Response |
| NCT00806819 (14) [back to overview] | Quality of Life (QoL) |
| NCT00806819 (14) [back to overview] | Objective Tumor Response |
| NCT00806819 (14) [back to overview] | Duration of Disease Control |
| NCT00807599 (2) [back to overview] | Overall Survival |
| NCT00807599 (2) [back to overview] | Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma. |
| NCT00833833 (10) [back to overview] | Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off |
| NCT00833833 (10) [back to overview] | Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1 |
| NCT00833833 (10) [back to overview] | Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off |
| NCT00833833 (10) [back to overview] | Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off |
| NCT00833833 (10) [back to overview] | Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off |
| NCT00833833 (10) [back to overview] | Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off |
| NCT00833833 (10) [back to overview] | Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off |
| NCT00833833 (10) [back to overview] | Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off |
| NCT00833833 (10) [back to overview] | Phase 2: Time to Response as of the 01 April 2011 Cut-off |
| NCT00833833 (10) [back to overview] | Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off |
| NCT00866307 (2) [back to overview] | AALL08P1 Safety Outcome |
| NCT00866307 (2) [back to overview] | AALL08P1 Feasibility Outcome |
| NCT00890552 (4) [back to overview] | Duration of Response |
| NCT00890552 (4) [back to overview] | Event-free Survival (EFS) |
| NCT00890552 (4) [back to overview] | Overall Survival (OS) |
| NCT00890552 (4) [back to overview] | Hematologic Response Rate |
| NCT00928200 (1) [back to overview] | Occurrence of a Dose-Limiting Toxicity |
| NCT00952133 (2) [back to overview] | Complete Response Rate |
| NCT00952133 (2) [back to overview] | Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery |
| NCT00952341 (8) [back to overview] | Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1 |
| NCT00952341 (8) [back to overview] | Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1 |
| NCT00952341 (8) [back to overview] | Proportion of Participants With No Impact on Daily Life in Cycle 1 |
| NCT00952341 (8) [back to overview] | Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1 |
| NCT00952341 (8) [back to overview] | Proportion of Participants With Complete Response in the Acute Phase of Cycle 1 |
| NCT00952341 (8) [back to overview] | Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1 |
| NCT00952341 (8) [back to overview] | Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1 |
| NCT00952341 (8) [back to overview] | Time to First Vomiting Episode in Cycle 1 |
| NCT00966693 (7) [back to overview] | Incidence of Adverse Events |
| NCT00966693 (7) [back to overview] | Progression Free Survival |
| NCT00966693 (7) [back to overview] | Number of Participants With Dose Limitations Toxicities of the Combination of Lenalidomide and Thalidomide and Dexamethasone (LTD) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) |
| NCT00966693 (7) [back to overview] | Time to Best Response |
| NCT00966693 (7) [back to overview] | Time to Next Therapy |
| NCT00966693 (7) [back to overview] | Complete Response(CR) and Very Good Partial Response(VGPR) |
| NCT00966693 (7) [back to overview] | Time to Progression |
| NCT00995501 (2) [back to overview] | Major Perioperative Morbidity |
| NCT00995501 (2) [back to overview] | 1 Year Mortality |
| NCT01029054 (3) [back to overview] | The Percentage of Patients Alive Without Progression |
| NCT01029054 (3) [back to overview] | The Maximum Tolerated Dose (MTD) of Carfilzomib |
| NCT01029054 (3) [back to overview] | The Percentage of Patients That Achieve a Response to Treatment |
| NCT01033825 (44) [back to overview] | Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline |
| NCT01033825 (44) [back to overview] | The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period |
| NCT01033825 (44) [back to overview] | Time to Maximal Effect Over 6 Weeks of Double-blind Treatment. |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported Individual AM and PM Reflective NSS |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported Individual AM Instantaneous NSS |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported Individual PM Instantaneous NSS |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported AM and PM Reflective TNSS |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported AM and PM Instantaneous TNSS |
| NCT01033825 (44) [back to overview] | Number of Subjects Experiencing Adverse Events (AEs) |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported Individual AM Reflective NSS |
| NCT01033825 (44) [back to overview] | Percentage of Subjects Experiencing Adverse Events (AEs) |
| NCT01033825 (44) [back to overview] | Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances. |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment |
| NCT01033825 (44) [back to overview] | Percentage of Subjects Experiencing Local Nasal AEs |
| NCT01033825 (44) [back to overview] | Percentage of Subjects Experiencing Serious Adverse Events (SAEs). |
| NCT01033825 (44) [back to overview] | Percentage of Subjects Who Discontinue Due to AEs |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment |
| NCT01033825 (44) [back to overview] | Percentage of Devices With Actuation Consistency |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment |
| NCT01033825 (44) [back to overview] | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment |
| NCT01033825 (44) [back to overview] | Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment |
| NCT01033825 (44) [back to overview] | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period |
| NCT01033825 (44) [back to overview] | Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported Individual PM Reflective NSS |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported AM Instantaneous TNSS |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported AM Reflective TNSS |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported PM Instantaneous TNSS |
| NCT01033825 (44) [back to overview] | Baseline Daily Subject-reported PM Reflective TNSS |
| NCT01033825 (44) [back to overview] | Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline |
| NCT01033825 (44) [back to overview] | Number of Devices With Major Discrepancies |
| NCT01033825 (44) [back to overview] | Number of Subjects Experiencing Local Nasal AEs |
| NCT01033825 (44) [back to overview] | Number of Subjects Experiencing Serious Adverse Events (SAEs). |
| NCT01033825 (44) [back to overview] | Number of Subjects Who Discontinue Due to AEs |
| NCT01033825 (44) [back to overview] | Percentage of Devices With Major Discrepancies |
| NCT01033825 (44) [back to overview] | Number of Devices With Actuation Consistency |
| NCT01036594 (1) [back to overview] | Number of Participants Who Achieved a Second Decline in Prostate Specific Antigen (PSA) Following Progression on First Regimen |
| NCT01052038 (5) [back to overview] | Subjects Assessment of Sore Throat Pain at 24 Hours |
| NCT01052038 (5) [back to overview] | Number of Subjects With Sore Throat at 3 Hours Post Surgery. |
| NCT01052038 (5) [back to overview] | Hoarseness at 24 Hours |
| NCT01052038 (5) [back to overview] | Quality of Recovery at 24 Hours |
| NCT01052038 (5) [back to overview] | Opioid Consumption at 24 Hours |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Change From Baseline in Health Related Quality of Life (HRQL) European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Scores: Global Health Status |
| NCT01084252 (41) [back to overview] | PK Assessment: Phase 1: Maximum Observed Plasma Concentration (Cmax) of Isatuximab |
| NCT01084252 (41) [back to overview] | PK Assessment: Phase 1: Maximum Observed Plasma Concentration (Cmax) of Isatuximab |
| NCT01084252 (41) [back to overview] | PK Assessment: Phase 1: Plasma Concentration of Isatuximab at Week 1, 2 and 3 |
| NCT01084252 (41) [back to overview] | PK Assessment: Phase 1: Time to Reach Maximum Plasma Concentration Observed (Tmax) of Isatuximab |
| NCT01084252 (41) [back to overview] | PK Assessment: Phase 1: Time to Reach Maximum Plasma Concentration Observed (Tmax) of Isatuximab |
| NCT01084252 (41) [back to overview] | Clinical Assessment: Phase 1: Duration of Response (DOR) |
| NCT01084252 (41) [back to overview] | Clinical Assessment: Phase 1: Time to First Response (TTR) |
| NCT01084252 (41) [back to overview] | Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 1 Week Interval |
| NCT01084252 (41) [back to overview] | Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 2 Weeks Interval |
| NCT01084252 (41) [back to overview] | Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 4 Weeks Interval |
| NCT01084252 (41) [back to overview] | Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs) |
| NCT01084252 (41) [back to overview] | Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Duration of Response |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Overall Survival (OS) |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Percentage of Participants With Clinical Benefit |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Percentage of Participants With Overall Response (OR) According to International Myeloma Working Group (IMWG) Uniform Response Criteria |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Progression Free Survival (PFS) |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 2: Duration of Response |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 2: Overall Survival |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 2: Percentage of Participants With Clinical Benefit |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 2: Percentage of Participants With Overall Response According to Updated IMWG Response Criteria |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 2: Progression Free Survival |
| NCT01084252 (41) [back to overview] | PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First 2 Weeks (0-336 Hours) (AUC2W) |
| NCT01084252 (41) [back to overview] | PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First Week (0-168 Hours) (AUC1W) |
| NCT01084252 (41) [back to overview] | Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (Karnofsky Performance Status)-Shift From Baseline Value to Best Value During Treatment |
| NCT01084252 (41) [back to overview] | Clinical Assessment: Phase 1: Number of Participants With Eastern Cooperative Oncology Group Performance Status (Karnofsky Performance Status)-Shift From Baseline Value to Worst Value During Treatment |
| NCT01084252 (41) [back to overview] | Clinical Assessment: Phase 1: Percentage of Participants With Overall Response and Clinical Benefit: Assessed Using European Society for Blood and Marrow Transplantation (EBMT) Criteria |
| NCT01084252 (41) [back to overview] | Immunogenicity Assessment: Phase 1: Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response |
| NCT01084252 (41) [back to overview] | Immunogenicity Assessment: Phase 2 Stage 2: Number of Participants With Anti-drug Antibodies to Isatuximab |
| NCT01084252 (41) [back to overview] | Pharmacodynamic (PD) Assessment: Phase 1: Change From Baseline in Serum/Plasma Markers |
| NCT01084252 (41) [back to overview] | Pharmacokinetic (PK) Assessment: Phase 1: Plasma Concentration of Isatuximab Observed at the End of an Intravenous Infusion (Ceoi) |
| NCT01084252 (41) [back to overview] | Pharmacokinetic (PK) Assessment: Phase 1: Plasma Concentration of Isatuximab Observed at the End of an Intravenous Infusion (Ceoi) |
| NCT01084252 (41) [back to overview] | Pharmacokinetic Assessment: Phase 2 Stage 2: Accumulation Ratio of Isatuximab Based on Ctrough |
| NCT01084252 (41) [back to overview] | Pharmacokinetic Assessment: Phase 2 Stage 2: Plasma Concentration of Isatuximab Before Treatment Administration (Ctrough) |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores |
| NCT01084252 (41) [back to overview] | Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score |
| NCT01111851 (4) [back to overview] | Brain NK1-receptor Occupancy at 48 Hours Post Dose |
| NCT01111851 (4) [back to overview] | Brain NK1-receptor Occupancy at 24 Hours Post Dose |
| NCT01111851 (4) [back to overview] | Brain NK1-receptor Occupancy at 120 Hours Post Dose |
| NCT01111851 (4) [back to overview] | Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax) |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning |
| NCT01190930 (41) [back to overview] | Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization |
| NCT01190930 (41) [back to overview] | DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization |
| NCT01190930 (41) [back to overview] | DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right |
| NCT01190930 (41) [back to overview] | Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical |
| NCT01190930 (41) [back to overview] | Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning |
| NCT01190930 (41) [back to overview] | DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens |
| NCT01190930 (41) [back to overview] | Sample Collection of Central Path Review Slides in B-LLy Patients |
| NCT01190930 (41) [back to overview] | Overall Survival (OS) for B-LLy Patients |
| NCT01190930 (41) [back to overview] | Event Free Survival (EFS) for B-LLy Patients |
| NCT01215344 (2) [back to overview] | The Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI). |
| NCT01215344 (2) [back to overview] | Progression Free Survival by MRD Status at Day 100. |
| NCT01230593 (2) [back to overview] | Number of Participants With Complete Resolution |
| NCT01230593 (2) [back to overview] | Chalazion Size Difference Post-Treatment |
| NCT01239797 (6) [back to overview] | Change From Baseline of Mean Score Pain Severity (BPI-SF) |
| NCT01239797 (6) [back to overview] | Median Overall Survival (OS) |
| NCT01239797 (6) [back to overview] | Median Progression Free Survival (PFS) - Extended Collection |
| NCT01239797 (6) [back to overview] | Objective Response Rate (ORR) |
| NCT01239797 (6) [back to overview] | Median Progression Free Survival (PFS) |
| NCT01239797 (6) [back to overview] | Change From Baseline of Mean Score Pain Interference (BPI-SF) |
| NCT01256398 (6) [back to overview] | Overall Survival (OS) |
| NCT01256398 (6) [back to overview] | Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR) |
| NCT01256398 (6) [back to overview] | Response |
| NCT01256398 (6) [back to overview] | Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring. |
| NCT01256398 (6) [back to overview] | Disease Free Survival (DFS) |
| NCT01256398 (6) [back to overview] | Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause |
| NCT01275664 (2) [back to overview] | Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis) |
| NCT01275664 (2) [back to overview] | Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0 |
| NCT01277159 (1) [back to overview] | Time it Takes for Nerve Block to Wear Off |
| NCT01294319 (2) [back to overview] | Post-dexamethasone Cortisol Level |
| NCT01294319 (2) [back to overview] | Proportion of Suppressors After Dexamethasone |
| NCT01295112 (1) [back to overview] | The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24 |
| NCT01335399 (5) [back to overview] | Objective Response Rate (ORR) |
| NCT01335399 (5) [back to overview] | Progression Free Survival (PFS) Rate at Specific Time-points |
| NCT01335399 (5) [back to overview] | Progression-Free Survival (PFS) |
| NCT01335399 (5) [back to overview] | Mean Change From Baseline of Pain Severity Score and Pain Interference Score |
| NCT01335399 (5) [back to overview] | Overall Survival (OS) |
| NCT01355705 (4) [back to overview] | Response Rates After Amrubicin + Lenalidomide + Dexamethasone, Per International Myeloma Working Group Uniform Response Criteria |
| NCT01355705 (4) [back to overview] | Time-to-next Treatment |
| NCT01355705 (4) [back to overview] | Duration of Response (DOR) |
| NCT01355705 (4) [back to overview] | Progression-free Survival (PFS) |
| NCT01363128 (3) [back to overview] | 4-year Event Free Survival |
| NCT01363128 (3) [back to overview] | 4-Year Overall Survival |
| NCT01363128 (3) [back to overview] | Number of Participants With Complete Remission (CR) |
| NCT01381692 (1) [back to overview] | Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone |
| NCT01383759 (3) [back to overview] | Progression Free Survival at 24 Months |
| NCT01383759 (3) [back to overview] | Percentage of Participants Experiencing Progression Free Survival at 12 Months |
| NCT01383759 (3) [back to overview] | Participants Evaluated for Toxicity |
| NCT01393964 (11) [back to overview] | Mean Terminal-phase Elimination Half-life (T-Half) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method |
| NCT01393964 (11) [back to overview] | Median Time to Maximal Concentration (Tmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method |
| NCT01393964 (11) [back to overview] | Geometric Mean Area Under Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) and From Time Zero Extrapolated to Infinite Time AUC(INF) of Elotuzumab Following Cycle 1, Day 1 - Grouping by C-G CrCl Method |
| NCT01393964 (11) [back to overview] | Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose. |
| NCT01393964 (11) [back to overview] | Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died |
| NCT01393964 (11) [back to overview] | Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests |
| NCT01393964 (11) [back to overview] | Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests |
| NCT01393964 (11) [back to overview] | Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests |
| NCT01393964 (11) [back to overview] | Geometric Mean Apparent Volume of Distribution (Vz) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method |
| NCT01393964 (11) [back to overview] | Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method |
| NCT01393964 (11) [back to overview] | Geometric Mean Total Body Clearance (CLT) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method |
| NCT01431014 (1) [back to overview] | Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery |
| NCT01449682 (4) [back to overview] | Macular Function Using Microperimetry |
| NCT01449682 (4) [back to overview] | Macular Function Using Multi-focal ERG |
| NCT01449682 (4) [back to overview] | To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups |
| NCT01449682 (4) [back to overview] | To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups |
| NCT01450007 (4) [back to overview] | Duration of Sensory Blockade |
| NCT01450007 (4) [back to overview] | Post Operative Opioid Dose at 24 Hours |
| NCT01450007 (4) [back to overview] | Time Until First Dose of Analgesic |
| NCT01450007 (4) [back to overview] | Patient Satisfaction With Pain Control |
| NCT01478048 (6) [back to overview] | Median Progression-free Survival Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause, in Randomized Participants With at Least One FcγRIIIa V Allele |
| NCT01478048 (6) [back to overview] | Median Investigator-Assessed Progression-free Survival (PFS) Time (Months) From Randomization to Date of First Tumor Progression or Death Due to Any Cause - Randomized Participants |
| NCT01478048 (6) [back to overview] | Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele |
| NCT01478048 (6) [back to overview] | Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants |
| NCT01478048 (6) [back to overview] | 1 Year Progression-Free Survival Rate - Randomized Participants |
| NCT01478048 (6) [back to overview] | Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants |
| NCT01483690 (2) [back to overview] | Disease Response Rate After Treatment. |
| NCT01483690 (2) [back to overview] | Number of Participants Who Experienced a Dose Limiting Toxicity (DLT). |
| NCT01488279 (3) [back to overview] | Change in Insulin Secretion (AIRg or Acute Insulinogenic Response to Glucose) |
| NCT01488279 (3) [back to overview] | Change in Glucose Response |
| NCT01488279 (3) [back to overview] | Insulin Sensitivity |
| NCT01490060 (1) [back to overview] | Complete Response |
| NCT01527149 (9) [back to overview] | Percentage of Participants With Autologous Stem Cell Transplantation |
| NCT01527149 (9) [back to overview] | Number of Participants With at Least One Serious Adverse Event |
| NCT01527149 (9) [back to overview] | Median Progression-free Survival (PFS) |
| NCT01527149 (9) [back to overview] | Median Overall Survival (OS) |
| NCT01527149 (9) [back to overview] | Median of Serum Complement CD20 Levels |
| NCT01527149 (9) [back to overview] | Change From Baseline in Percentage of Cells Positive for Ki67 |
| NCT01527149 (9) [back to overview] | Proportion of Patients Who Experience Complete Remission as Assessed by HSFCM |
| NCT01527149 (9) [back to overview] | Time-to-tumor Progression (TTP) at 3 Years |
| NCT01527149 (9) [back to overview] | Proportion of Patients Experiencing a Complete Response |
| NCT01545700 (2) [back to overview] | Pain Scores |
| NCT01545700 (2) [back to overview] | Serum Blood Glucose Concentrations |
| NCT01546402 (2) [back to overview] | Change in the Central Macular Thickness |
| NCT01546402 (2) [back to overview] | Change in the Visual Acuity |
| NCT01559935 (4) [back to overview] | Response to Car-BiRD Treatment. |
| NCT01559935 (4) [back to overview] | Stem Cells Collection |
| NCT01559935 (4) [back to overview] | Progression Free Survival |
| NCT01559935 (4) [back to overview] | Event Free Survival |
| NCT01570387 (4) [back to overview] | Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 4 Milligram Dose |
| NCT01570387 (4) [back to overview] | Response to the Maximal Tolerated Dose |
| NCT01570387 (4) [back to overview] | Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 2 Milligram Dose |
| NCT01570387 (4) [back to overview] | Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 3 Milligram Dose |
| NCT01586806 (5) [back to overview] | NRS (Numerical Rating Scale) Pain Scores |
| NCT01586806 (5) [back to overview] | Opioid-Related Side Effects (Drowsiness) |
| NCT01586806 (5) [back to overview] | Patient Satisfaction |
| NCT01586806 (5) [back to overview] | Postoperative Morphine Consumption |
| NCT01586806 (5) [back to overview] | Patient-perceived Duration of Analgesia |
| NCT01594749 (6) [back to overview] | Percentage of Participants With Severe Infusion-site Reactions |
| NCT01594749 (6) [back to overview] | Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC |
| NCT01594749 (6) [back to overview] | Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC) |
| NCT01594749 (6) [back to overview] | Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC |
| NCT01594749 (6) [back to overview] | Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC |
| NCT01594749 (6) [back to overview] | Percentage of Participants With Infusion-site Thrombophlebitis |
| NCT01616173 (3) [back to overview] | Pain Scores |
| NCT01616173 (3) [back to overview] | Opioid Consumption |
| NCT01616173 (3) [back to overview] | Quality of Recovery |
| NCT01632150 (4) [back to overview] | Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) |
| NCT01632150 (4) [back to overview] | Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs) |
| NCT01632150 (4) [back to overview] | Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event |
| NCT01632150 (4) [back to overview] | Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event |
| NCT01636947 (8) [back to overview] | Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages |
| NCT01636947 (8) [back to overview] | Percentage of Participants With No Impact on Daily Life - Overall Stage |
| NCT01636947 (8) [back to overview] | Percentage of Participants With No Vomiting - Acute and Delayed Stages |
| NCT01636947 (8) [back to overview] | Number of Emetic Events - Overall Stage |
| NCT01636947 (8) [back to overview] | Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage |
| NCT01636947 (8) [back to overview] | Percentage of Participants With One or More Clinical Adverse Event |
| NCT01636947 (8) [back to overview] | The Percentage of Participants With No Vomiting - Overall Stage |
| NCT01636947 (8) [back to overview] | Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages |
| NCT01639599 (4) [back to overview] | Incidence of Postoperative Nausea and Vomiting |
| NCT01639599 (4) [back to overview] | Sedation Change in Recovery Room |
| NCT01639599 (4) [back to overview] | Incidence of Extrapyramidal Symptoms |
| NCT01639599 (4) [back to overview] | Incidence of Cardiac Arrhythmia |
| NCT01668719 (5) [back to overview] | Progression-free Survival |
| NCT01668719 (5) [back to overview] | Number of Participants With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs |
| NCT01668719 (5) [back to overview] | Response (Partial Response [PR] or Better) Rate |
| NCT01668719 (5) [back to overview] | Overall Survival |
| NCT01668719 (5) [back to overview] | Phase I: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Bortezomib, Lenalidomide and Dexamethasone |
| NCT01672736 (1) [back to overview] | Maximum Tolerated Dose of the Combination of ASP7487 (OSI-906) With Velcade and Dexamethasone |
| NCT01702233 (13) [back to overview] | Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation |
| NCT01702233 (13) [back to overview] | Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Fortecortin at Visit 7 (Day 105) |
| NCT01702233 (13) [back to overview] | Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 5 (Day 22) |
| NCT01702233 (13) [back to overview] | Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 7 (Day 105) |
| NCT01702233 (13) [back to overview] | Change From Baseline in DASH at Visit 5 (Day 22) |
| NCT01702233 (13) [back to overview] | Change From Baseline in DASH at Visit 7 (Day 105) |
| NCT01702233 (13) [back to overview] | Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22) Traumeel vs Fortecortin |
| NCT01702233 (13) [back to overview] | Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo |
| NCT01702233 (13) [back to overview] | Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Fortecortin |
| NCT01702233 (13) [back to overview] | Painful Arc Test at Visit 5 (Day 22) |
| NCT01702233 (13) [back to overview] | Jobe Test at Visit 5 (Day 22) With Measurement of Weakness |
| NCT01702233 (13) [back to overview] | Jobe Test at Visit 5 (Day 15) With Measurement of Pain |
| NCT01702233 (13) [back to overview] | Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo |
| NCT01748942 (7) [back to overview] | Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale |
| NCT01748942 (7) [back to overview] | Opioid Use |
| NCT01748942 (7) [back to overview] | Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge) |
| NCT01748942 (7) [back to overview] | Eating Assessment Tool (EAT)-10 Scores |
| NCT01748942 (7) [back to overview] | Days With Feeding Tube |
| NCT01748942 (7) [back to overview] | PSS Normalcy of Diet |
| NCT01748942 (7) [back to overview] | UM-QOL Eating |
| NCT01794039 (4) [back to overview] | Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
| NCT01794039 (4) [back to overview] | Overall Survival |
| NCT01794039 (4) [back to overview] | Time to Progression |
| NCT01794039 (4) [back to overview] | Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations |
| NCT01864018 (7) [back to overview] | Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I) |
| NCT01864018 (7) [back to overview] | Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B) |
| NCT01864018 (7) [back to overview] | Survival Time |
| NCT01864018 (7) [back to overview] | Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I) |
| NCT01864018 (7) [back to overview] | Progression-free Survival (PFS) |
| NCT01864018 (7) [back to overview] | Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A) |
| NCT01864018 (7) [back to overview] | Number of Patients Experiencing a Grade 3 or Greater Adverse Event at Least Possibly Related to Treatment as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
| NCT01891643 (3) [back to overview] | Change From Baseline in the Levels of CS1 Soluble Form (sCS1) in Serum During Therapy and At Progression |
| NCT01891643 (3) [back to overview] | Levels of CS1 Soluble Form (sCS1) in Serum |
| NCT01891643 (3) [back to overview] | Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression |
| NCT01903811 (5) [back to overview] | Overall Survival Crossover Group |
| NCT01903811 (5) [back to overview] | Progression-free Survival |
| NCT01903811 (5) [back to overview] | Progression-free Survival of Crossover Group |
| NCT01903811 (5) [back to overview] | Overall Survival |
| NCT01903811 (5) [back to overview] | Best Overall Response - Partial Response (PR), Very Good Partial Response (VGPR), Unconfirmed PR (uPR), Stable Disease (SD) Progression (PROG) |
| NCT01946152 (4) [back to overview] | Number of Participants With Best Overall Response Defined Using the International Myeloma Working Group Uniform Response Criteria (IMWG-URC) |
| NCT01946152 (4) [back to overview] | Number of Participants With Progression-free Survival |
| NCT01946152 (4) [back to overview] | Maximum Tolerated Dose (MTD) (Phase I) |
| NCT01946152 (4) [back to overview] | Number of Participants Recommended Phase II Dose of Pomalidomide and Dexamethasone, When Both Agents Are Administered Together With Granulocyte-colony Stimulating Factor (Filgrastim) (Phase I) |
| NCT01979536 (3) [back to overview] | Event Free Survival (EFS) |
| NCT01979536 (3) [back to overview] | Occurrence of Grade 3+ Non-hematologic Adverse Events |
| NCT01979536 (3) [back to overview] | Prognostic Significance of Minimal Residual Disease |
| NCT02084134 (2) [back to overview] | Number of Participants With Adrenal Insufficiency |
| NCT02084134 (2) [back to overview] | Percentage of Patients Discharged on Glucocorticoids |
| NCT02101853 (4) [back to overview] | Overall Survival (OS) of HR and IR Relapse Patients |
| NCT02101853 (4) [back to overview] | Disease Free Survival (DFS) of High-risk (HR) and Intermediate-risk (IR) Relapse Patients |
| NCT02101853 (4) [back to overview] | Overall Survival (OS) of LR Relapse Patients |
| NCT02101853 (4) [back to overview] | Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients |
| NCT02112916 (6) [back to overview] | Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase |
| NCT02112916 (6) [back to overview] | Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients |
| NCT02112916 (6) [back to overview] | Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT) |
| NCT02112916 (6) [back to overview] | EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond |
| NCT02112916 (6) [back to overview] | EFS for Standard (SR) and Intermediate Risk (IR) T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no Cranial Radiation Therapy [CRT]) and Similar Patients on AALL0434 (Received CRT) |
| NCT02112916 (6) [back to overview] | EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3 |
| NCT02128230 (1) [back to overview] | The Remission Rate for Participants With High-risk Myeloma |
| NCT02151487 (2) [back to overview] | Duration of the Sensorial Supraclavicular Block |
| NCT02151487 (2) [back to overview] | Postoperative Analgesia |
| NCT02192827 (3) [back to overview] | Reported Side Effects Experienced by Participants |
| NCT02192827 (3) [back to overview] | Reported Number of Days Until Symptom Resolution |
| NCT02192827 (3) [back to overview] | Number of Participants Returning to Care Following Discharge From the Emergency Department |
| NCT02216071 (3) [back to overview] | Number of Participants With Microbiological Cure (MC) |
| NCT02216071 (3) [back to overview] | Number of Participants With Adverse Events |
| NCT02216071 (3) [back to overview] | Number of Participants With Clinical Cure of AOE |
| NCT02219581 (9) [back to overview] | Pain Score |
| NCT02219581 (9) [back to overview] | Range of Motion (ROM) |
| NCT02219581 (9) [back to overview] | Antiemetic Dose Administered |
| NCT02219581 (9) [back to overview] | Blood Glucose |
| NCT02219581 (9) [back to overview] | Post-operative Day of Physical Therapy Clearance |
| NCT02219581 (9) [back to overview] | Length of Hospital Stay |
| NCT02219581 (9) [back to overview] | Number of Participants Readmitted to the Hospital |
| NCT02219581 (9) [back to overview] | Number of Participants With Wound Infections |
| NCT02219581 (9) [back to overview] | Opioid Analgesic Usage |
| NCT02226159 (13) [back to overview] | Patient Satisfaction |
| NCT02226159 (13) [back to overview] | Patient Satisfaction |
| NCT02226159 (13) [back to overview] | Patient Satisfaction |
| NCT02226159 (13) [back to overview] | Numeric Pain Score |
| NCT02226159 (13) [back to overview] | Numeric Pain Score |
| NCT02226159 (13) [back to overview] | Numeric Pain Score |
| NCT02226159 (13) [back to overview] | Disability |
| NCT02226159 (13) [back to overview] | Disability |
| NCT02226159 (13) [back to overview] | Disability |
| NCT02226159 (13) [back to overview] | Disability |
| NCT02226159 (13) [back to overview] | Numeric Pain Scre |
| NCT02226159 (13) [back to overview] | Avoidance of Neck Surgery |
| NCT02226159 (13) [back to overview] | Patient Satisfaction |
| NCT02253316 (6) [back to overview] | Response Rate of IRD Consolidation |
| NCT02253316 (6) [back to overview] | Rate of MRD-positive to MRD-negative Conversion Between the Two Maintenance Arms |
| NCT02253316 (6) [back to overview] | Number of Participants With Improvement in Minimal Residual Disease (MRD) |
| NCT02253316 (6) [back to overview] | MRD-negative Rate After ASCT |
| NCT02253316 (6) [back to overview] | Compare Response Rate Between the Two Maintenance Arms |
| NCT02253316 (6) [back to overview] | Toxicity of IRD Consolidation |
| NCT02271698 (5) [back to overview] | Change in Visual Analogue Pain Score |
| NCT02271698 (5) [back to overview] | Change in Opioid Consumption |
| NCT02271698 (5) [back to overview] | Change in Functional Status as Measured by Western Ontario and McMaster Universities Osteoarthritis Index |
| NCT02271698 (5) [back to overview] | Change in Functional Status as Measured by Brief Pain Inventory Questionnaire |
| NCT02271698 (5) [back to overview] | Change in Chronic Pain as Measured by Brief Pain Inventory Questionnaire |
| NCT02322242 (10) [back to overview] | Duration of Motor Block |
| NCT02322242 (10) [back to overview] | Duration of Sensory Block |
| NCT02322242 (10) [back to overview] | Infection |
| NCT02322242 (10) [back to overview] | Number of Participants With Nerve Damage From Interscalene Block |
| NCT02322242 (10) [back to overview] | Number of Participants With Postoperative Nausea and/or Vomiting |
| NCT02322242 (10) [back to overview] | Opioid Consumption |
| NCT02322242 (10) [back to overview] | Post-operative Oxygen Saturation on Room Air |
| NCT02322242 (10) [back to overview] | Time to First Opioid Consumption |
| NCT02322242 (10) [back to overview] | Numeric Rating Scale for Pain (NRS 0-10) |
| NCT02322242 (10) [back to overview] | Postoperative Serum Blood Glucose |
| NCT02339740 (2) [back to overview] | Event-free Survival (EFS) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients |
| NCT02339740 (2) [back to overview] | EFS in High Risk APL Patients |
| NCT02419469 (1) [back to overview] | Event Free Survival (EFS) |
| NCT02420717 (4) [back to overview] | Progression-free Survival |
| NCT02420717 (4) [back to overview] | Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I) |
| NCT02420717 (4) [back to overview] | Overall Survival |
| NCT02420717 (4) [back to overview] | Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II) |
| NCT02421419 (4) [back to overview] | VAS |
| NCT02421419 (4) [back to overview] | Presence of Triggering |
| NCT02421419 (4) [back to overview] | Number of Participants With Adverse Effects |
| NCT02421419 (4) [back to overview] | Degree of Triggering |
| NCT02462148 (6) [back to overview] | Verbal Pain Scores |
| NCT02462148 (6) [back to overview] | Duration of Sensory Nerve Block |
| NCT02462148 (6) [back to overview] | Neurologic Complications |
| NCT02462148 (6) [back to overview] | Post Operative Opioid Use and Consumption |
| NCT02462148 (6) [back to overview] | Rate of Post Operative Nausea and Vomiting |
| NCT02462148 (6) [back to overview] | Time to First Opioid Analgesic Request |
| NCT02464176 (4) [back to overview] | Duration of Sensory Blockade |
| NCT02464176 (4) [back to overview] | Verbal Numeric Pain Score Comparisons |
| NCT02464176 (4) [back to overview] | Total Opioid Consumption |
| NCT02464176 (4) [back to overview] | Time to First Analgesic Request |
| NCT02491632 (4) [back to overview] | Change in Multidimensional Fatigue Symptom Inventory-Short Form (MFSI_SF) Total Score |
| NCT02491632 (4) [back to overview] | Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue |
| NCT02491632 (4) [back to overview] | Change in Patient Reported Outcome Measurement Information System-Fatigue (PROMIS-F) Total |
| NCT02491632 (4) [back to overview] | Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29 |
| NCT02492750 (2) [back to overview] | Number of Participants Experiencing a Dose-limiting Toxicity (DLT) |
| NCT02492750 (2) [back to overview] | Number of Participants Who Experienced at Least One Grade 3+ Adverse Events Deemed at Least Possibly Related to Treatment, Graded According to NCI CTCAE Version 4.0 |
| NCT02506660 (7) [back to overview] | Block-related Complications |
| NCT02506660 (7) [back to overview] | Nerve Block Duration |
| NCT02506660 (7) [back to overview] | Side Effects |
| NCT02506660 (7) [back to overview] | Opioid Consumption |
| NCT02506660 (7) [back to overview] | Numerical Rating Scale Pain Scores |
| NCT02506660 (7) [back to overview] | Block Satisfaction |
| NCT02506660 (7) [back to overview] | % of Participants Who Guessed the Correct Group |
| NCT02547662 (5) [back to overview] | Progression-free Survival |
| NCT02547662 (5) [back to overview] | Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 |
| NCT02547662 (5) [back to overview] | Extramedullary Response Rate |
| NCT02547662 (5) [back to overview] | Confirmed Response Rate |
| NCT02547662 (5) [back to overview] | Biochemical Response Rate |
| NCT02581839 (6) [back to overview] | Median Duration of CNS Response |
| NCT02581839 (6) [back to overview] | Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS) |
| NCT02581839 (6) [back to overview] | Objective Response Rate (RR) |
| NCT02581839 (6) [back to overview] | Number of Patients With CBR |
| NCT02581839 (6) [back to overview] | Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events |
| NCT02581839 (6) [back to overview] | Median Overall Survival (OS) |
| NCT02633059 (8) [back to overview] | Overall Survival (Phase II) |
| NCT02633059 (8) [back to overview] | Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II) |
| NCT02633059 (8) [back to overview] | Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II) |
| NCT02633059 (8) [back to overview] | Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I) |
| NCT02633059 (8) [back to overview] | The Number of Participants Who Experienced Dose Limiting Toxicities. Maximum Tolerated Dose (MTD) of Ixazomib Citrate and Idasanutlin in Combination With Dexamethasone (Phase I) |
| NCT02633059 (8) [back to overview] | Rate of Partial Response (PR) (Phase II) |
| NCT02633059 (8) [back to overview] | Rate of Complete Response (CR) (Phase II) |
| NCT02633059 (8) [back to overview] | Progression Free Survival (Phase II) |
| NCT02654132 (3) [back to overview] | Overall Survival (OS) |
| NCT02654132 (3) [back to overview] | Objective Response Rate (ORR) |
| NCT02654132 (3) [back to overview] | Progression Free Survival (PFS) |
| NCT02688530 (9) [back to overview] | Occurrence of Postoperative Neuropraxia |
| NCT02688530 (9) [back to overview] | Duration of Motor Block From the Supraclavicular Block |
| NCT02688530 (9) [back to overview] | Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy |
| NCT02688530 (9) [back to overview] | Cumulative Daily Opioid Usage |
| NCT02688530 (9) [back to overview] | Blood Glucose Levels |
| NCT02688530 (9) [back to overview] | Average Daily Pain Scores at Rest and With Movement |
| NCT02688530 (9) [back to overview] | Patient Satisfaction With Postoperative Analgesia |
| NCT02688530 (9) [back to overview] | Occurrence of Postoperative Wound Infection |
| NCT02688530 (9) [back to overview] | Worst Daily Pain Scores at Rest and With Movement |
| NCT02732015 (1) [back to overview] | Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose |
| NCT02798835 (10) [back to overview] | Cumulative 24 Hour Oral Morphine Equivalent Consumption |
| NCT02798835 (10) [back to overview] | Quality of Recovery (QoR-40) |
| NCT02798835 (10) [back to overview] | Incidence of Participants With Nausea/Vomiting Requiring Anti-emetics |
| NCT02798835 (10) [back to overview] | Time to First Use of PCA |
| NCT02798835 (10) [back to overview] | Nerve Block Complications |
| NCT02798835 (10) [back to overview] | Length of Stay |
| NCT02798835 (10) [back to overview] | Cumulative 48 Hour Oral Morphine Equivalent Consumption |
| NCT02798835 (10) [back to overview] | Adductor Canal Block Complications |
| NCT02798835 (10) [back to overview] | Cumulative 12 Hour Oral Morphine Equivalent Consumption |
| NCT02798835 (10) [back to overview] | Pain Score |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine |
| NCT02828358 (5) [back to overview] | Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R) |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine |
| NCT02828358 (5) [back to overview] | Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine |
| NCT02880228 (5) [back to overview] | Proportion of Complete Response Plus Very Good Partial Response (VGPR) |
| NCT02880228 (5) [back to overview] | Survival Time |
| NCT02880228 (5) [back to overview] | Partial Response (PR) |
| NCT02880228 (5) [back to overview] | Proportion of Successful Stem Cell Collection |
| NCT02880228 (5) [back to overview] | Progression-free Survival |
| NCT02891798 (8) [back to overview] | Short-Form McGill Pain Questionnaire (Version 2) Total Score Difference From Baseline |
| NCT02891798 (8) [back to overview] | SF-MPQ2 Intermittent Pain Subscore Difference From Baseline |
| NCT02891798 (8) [back to overview] | SF-MPQ2 Continuous Pain Subscore Difference From Baseline |
| NCT02891798 (8) [back to overview] | Quality of Recovery 15 Item Scale (QoR-15) Total Score |
| NCT02891798 (8) [back to overview] | Quality of Recovery 15 Item Scale (QoR-15) Total Score |
| NCT02891798 (8) [back to overview] | Performed-based Physical Function is Assessed Using the Standing Balance Test. |
| NCT02891798 (8) [back to overview] | Performed-based Physical Function is Assessed Using the Self-Selected Gait Speed Test. |
| NCT02891798 (8) [back to overview] | Performed-based Physical Function is Assessed Using the Repeated Chair Stand Test. |
| NCT02956070 (3) [back to overview] | Visual Analogic Scale (0-100) for Tooth Sensibility. |
| NCT02956070 (3) [back to overview] | Visual Analogic Scale(0-100) for Tooth Sensibility. |
| NCT02956070 (3) [back to overview] | Visual Analogic Scale(0-100) for Tooth Sensibility. |
| NCT02996591 (16) [back to overview] | Incidence of Transient Neurologic Symptoms |
| NCT02996591 (16) [back to overview] | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) |
| NCT02996591 (16) [back to overview] | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) |
| NCT02996591 (16) [back to overview] | Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst) |
| NCT02996591 (16) [back to overview] | Numerical Rating Scale Pain Scores on Postoperative Day (POD) 1 |
| NCT02996591 (16) [back to overview] | Cognitive Recovery on POD1 |
| NCT02996591 (16) [back to overview] | Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop |
| NCT02996591 (16) [back to overview] | Back Pain on POD1 |
| NCT02996591 (16) [back to overview] | Time Until Patient is Ready for Discharge From Post-Anesthesia Care Unit (PACU) to Home. |
| NCT02996591 (16) [back to overview] | Opioid-Related Symptom Distress Scale (ORSDS) Score |
| NCT02996591 (16) [back to overview] | Cognitive Recovery at 2 Hours Post-operative |
| NCT02996591 (16) [back to overview] | Opioid Consumption Through First Postoperative Day. Measured in mg OME |
| NCT02996591 (16) [back to overview] | Assessment of Patient Blinding to Group Assignment |
| NCT02996591 (16) [back to overview] | Nausea Intensity |
| NCT02996591 (16) [back to overview] | Opioid Consumption |
| NCT02996591 (16) [back to overview] | Numerical Rating Scale Pain Scores at 2 Hours Postop |
| NCT02999633 (1) [back to overview] | Percentage of Participants With Objective Response |
| NCT03033511 (4) [back to overview] | Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high) |
| NCT03033511 (4) [back to overview] | OS in All Randomized Participants |
| NCT03033511 (4) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time |
| NCT03033511 (4) [back to overview] | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time |
| NCT03035929 (4) [back to overview] | Changes in NT-proANP |
| NCT03035929 (4) [back to overview] | Changes in NT-proBNP |
| NCT03035929 (4) [back to overview] | Changes in NT-proANP From Baseline to 8 Hours |
| NCT03035929 (4) [back to overview] | Changes in NT-proBNP From Baseline to 8 Hours |
| NCT03098420 (3) [back to overview] | First Post-Operative Opioid Administration |
| NCT03098420 (3) [back to overview] | Average Opioid Consumption |
| NCT03098420 (3) [back to overview] | Average Pain Score |
| NCT03202628 (5) [back to overview] | Progression-free Survival at 18 Months (PFS18) Defined as the Proportion of Patients Alive and Free From Disease Progression at 18 Months From Study Entry |
| NCT03202628 (5) [back to overview] | Percentage of Participants With Greater Than or Equal to (>=) Very Good Partial Response (VGPR) Rate |
| NCT03202628 (5) [back to overview] | Percent of Patients Alive at 30 Months |
| NCT03202628 (5) [back to overview] | Overall Response Rate |
| NCT03202628 (5) [back to overview] | Number of Patients Experiencing Adverse Events Graded According to the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 12.1 |
| NCT03224507 (8) [back to overview] | Overall Survival |
| NCT03224507 (8) [back to overview] | Percentage of Patients With MRD(-) Remissions at the Completion of Consolidation Therapy |
| NCT03224507 (8) [back to overview] | Percentage of Patients Achieving Complete Remission Following Complete Therapy |
| NCT03224507 (8) [back to overview] | Percentage of Patients That Convert From MRD(-) to MRD(+) Following Treatment Discontinuation |
| NCT03224507 (8) [back to overview] | Serious Adverse Events (SAEs) From the KRdD Treatment |
| NCT03224507 (8) [back to overview] | Progression-free Survival |
| NCT03224507 (8) [back to overview] | Percentage of Patients With MRD(-) Status at the Completion of Induction Therapy |
| NCT03224507 (8) [back to overview] | Percentage of Patients With Auto-HCT That Convert From Positive to Negative MRD |
| NCT03256045 (6) [back to overview] | Synergy of Panobinostat and Dexamethasone in Combination, Per Subject |
| NCT03256045 (6) [back to overview] | Best Overall Response, by Subject |
| NCT03256045 (6) [back to overview] | Synergy of Panobinostat and Carfilzomib in Combination, Per Subject. |
| NCT03256045 (6) [back to overview] | Multiple Myeloma Cells In-vitro Drug Sensitivity to Dexamethasone, by Subject |
| NCT03256045 (6) [back to overview] | Multiple Myeloma Cells In-vitro Drug Sensitivity to Carfilzomib, by Subject |
| NCT03256045 (6) [back to overview] | Multiple Myeloma Cells In-vitro Drug Sensitivity to Panobinostat, by Subject |
| NCT03292926 (3) [back to overview] | Discharge Criteria |
| NCT03292926 (3) [back to overview] | Pain While at Rest |
| NCT03292926 (3) [back to overview] | Pain With Ambulation |
| NCT03367156 (8) [back to overview] | Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7 |
| NCT03367156 (8) [back to overview] | Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between Baseline and Day 14 |
| NCT03367156 (8) [back to overview] | Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 14 |
| NCT03367156 (8) [back to overview] | Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity |
| NCT03367156 (8) [back to overview] | Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness |
| NCT03367156 (8) [back to overview] | Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity |
| NCT03367156 (8) [back to overview] | Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7 |
| NCT03367156 (8) [back to overview] | Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness |
| NCT03382821 (4) [back to overview] | Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III |
| NCT03382821 (4) [back to overview] | Neck Disability Index-5 |
| NCT03382821 (4) [back to overview] | "The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)" |
| NCT03382821 (4) [back to overview] | The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score |
| NCT03488225 (5) [back to overview] | Overall Survival |
| NCT03488225 (5) [back to overview] | Number of Participants With Minimal Residual Disease (MRD) Negativity |
| NCT03488225 (5) [back to overview] | Event-Free Survival |
| NCT03488225 (5) [back to overview] | Number of Participants With Adverse Events |
| NCT03488225 (5) [back to overview] | Participants to Achieve Complete Remission (CR): |
| NCT03506360 (6) [back to overview] | >= Very Good Partial Response (VGPR) Response Percentage With Pembrolizumab Added to Ixazomib Citrate and Dexamethasone |
| NCT03506360 (6) [back to overview] | Complete Response Percentage With Pembrolizumab Added to Ixazomib Citrate and Dexamethasone |
| NCT03506360 (6) [back to overview] | Incidence of Adverse Events |
| NCT03506360 (6) [back to overview] | Overall Response Percentage |
| NCT03506360 (6) [back to overview] | Progression-free Survival |
| NCT03506360 (6) [back to overview] | Survival Time |
| NCT03518112 (5) [back to overview] | Event Free Survival (EFS) Where Events Defined as no Response, Loss of Response, or Death |
| NCT03518112 (5) [back to overview] | Duration of Response |
| NCT03518112 (5) [back to overview] | Participants With a Response |
| NCT03518112 (5) [back to overview] | Overall Survival |
| NCT03518112 (5) [back to overview] | Number of Participants Negative for Minimal Residual Disease (MRD) |
| NCT03608839 (6) [back to overview] | Macular Thickness at 3 Days After Intravitreous Dexamethasone |
| NCT03608839 (6) [back to overview] | Macular Thickness at 28 Days After Intravitreous Dexamethasone |
| NCT03608839 (6) [back to overview] | Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone |
| NCT03608839 (6) [back to overview] | Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone |
| NCT03608839 (6) [back to overview] | Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone |
| NCT03608839 (6) [back to overview] | Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone |
| NCT03705273 (2) [back to overview] | Number of Participants Requiring Second Dose of Dexamethasone |
| NCT03705273 (2) [back to overview] | Number of Participants With Nausea |
| NCT03739528 (10) [back to overview] | Total Ocular Symptoms Score (TOSS) |
| NCT03739528 (10) [back to overview] | Ocular Pain/Discomfort: 4-point Scale |
| NCT03739528 (10) [back to overview] | Visual Acuity |
| NCT03739528 (10) [back to overview] | Adverse Events |
| NCT03739528 (10) [back to overview] | Number of Participants Without Signs of Anterior Ocular Chamber Inflammation |
| NCT03739528 (10) [back to overview] | Burning, Stinging, Blurred Vision |
| NCT03739528 (10) [back to overview] | Global Evaluation of Local Tolerability |
| NCT03739528 (10) [back to overview] | Conjunctival Hyperemia |
| NCT03739528 (10) [back to overview] | Intraocular Pressure (IOP) |
| NCT03739528 (10) [back to overview] | Number of Participants With Endophthalmitis |
| NCT03739593 (1) [back to overview] | Safety Tolerability: Number of Ocular and Non-ocular TEAEs |
| NCT03740659 (3) [back to overview] | Aqueous Humour Concentration of Levofloxacin |
| NCT03740659 (3) [back to overview] | Aqueous Humour Concentration of Dexamethasone 21-phosphate |
| NCT03740659 (3) [back to overview] | Aqueous Humour Concentration of Dexamethasone |
| NCT03855059 (1) [back to overview] | Analgesia Duration |
| NCT03871829 (10) [back to overview] | Number of Participants With Anti-Daratumumab Antibodies |
| NCT03871829 (10) [back to overview] | Serum Concentrations of Daratumumab |
| NCT03871829 (10) [back to overview] | Time to Next Treatment |
| NCT03871829 (10) [back to overview] | Progression Free Survival (PFS) |
| NCT03871829 (10) [back to overview] | Percentage of Participants With Negative Minimal Residual Disease (MRD) |
| NCT03871829 (10) [back to overview] | Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better Response |
| NCT03871829 (10) [back to overview] | Percentage of Participants Achieving Complete Response (CR) or Better |
| NCT03871829 (10) [back to overview] | Overall Survival (OS) |
| NCT03871829 (10) [back to overview] | Overall Response Rate (ORR) |
| NCT03871829 (10) [back to overview] | Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies |
| NCT04290676 (1) [back to overview] | Percentage of Eyes With Anterior Chamber Cell Grade 0 |
| NCT04425863 (5) [back to overview] | Patients Needing Drug Dose Adjustment |
| NCT04425863 (5) [back to overview] | Patients Who Improved Their Condition or Did Not Worsen it |
| NCT04425863 (5) [back to overview] | Mortality |
| NCT04425863 (5) [back to overview] | ICU-treated Patients After 2-week Treatment |
| NCT04425863 (5) [back to overview] | Adverse Events |
| NCT04540133 (2) [back to overview] | Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks |
| NCT04540133 (2) [back to overview] | Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks |
| NCT04834375 (12) [back to overview] | Number of Participants That Developed Clinically Significant Hyperglycemia |
| NCT04834375 (12) [back to overview] | Number of Participants Admitted to the ICU |
| NCT04834375 (12) [back to overview] | Days of Stay in the Intensive Care Unit |
| NCT04834375 (12) [back to overview] | Duration of Invasive Mechanical Ventilation |
| NCT04834375 (12) [back to overview] | Days of Hospitalization |
| NCT04834375 (12) [back to overview] | All Cause Mortality at 28 Days |
| NCT04834375 (12) [back to overview] | Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital |
| NCT04834375 (12) [back to overview] | Number of Participants That Required Invasive Mechanical Ventilation |
| NCT04834375 (12) [back to overview] | Number of Participants That Required Higher Levels of Oxygen Supplementation |
| NCT04834375 (12) [back to overview] | Number of Participants That Required ECMO |
| NCT04834375 (12) [back to overview] | Number of Participants That Developed Secondary Bacterial or Fungal Infections |
| NCT04834375 (12) [back to overview] | Number of Participants That Required Tracheostomy |
| NCT05372315 (2) [back to overview] | Ease of Insertion |
| NCT05372315 (2) [back to overview] | Attempts to Achieve Successful Insertion |
Overall Survival
Probability of overall survival which is defined as the time from study entry to death from any cause. Patients alive where censored at last contact. (NCT00025259)
Timeframe: 5 years
| Intervention | Probability of survival (Number) |
|---|
| Arm I (Patients Off-therapy Before Callback-Induction Only) | 0.93 |
| Arm II (RER With CR [ABVE-PC, IFRT]) | 0.98 |
| Arm III (RER With CR [ABVE-PC]) | 0.98 |
| Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 0.98 |
| Arm VI (SER [DECA, ABVE-PC, IFRT]) | 0.96 |
| Arm VII (SER [ABVE-PC, IFRT]) | 0.93 |
Disease Response Assessed by Modified RECIST Criteria
Number of participants with complete response and very good partial response at the end of protocol therapy. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1527) an average of 137.1 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
| Intervention | Number of participants (Number) |
|---|
| Arm I (Patients Off-therapy Before Callback-Induction Only) | 5 |
| Arm II (RER With CR [ABVE-PC, IFRT]) | 370 |
| Arm III (RER With CR [ABVE-PC]) | 380 |
| Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 538 |
| Arm V (RER With PD) | 29 |
| Arm VI (SER [DECA, ABVE-PC, IFRT]) | 105 |
| Arm VII (SER [ABVE-PC, IFRT]) | 100 |
Event-free Survival
Probability of event-Free survival which is defined as the time from study entry to treatment failure (disease progression, disease recurrence, biopsy positive residual after completion of all protocol therapy), occurrence of a second malignant neoplasm, or death from any cause. Patients without report of such events where censored at last contact. (NCT00025259)
Timeframe: 5 years
| Intervention | Probability of survival (Number) |
|---|
| Arm I (Patients Off-therapy Before Callback-Induction Only) | 0.89 |
| Arm II (RER With CR [ABVE-PC, IFRT]) | 0.87 |
| Arm III (RER With CR [ABVE-PC]) | 0.84 |
| Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 0.87 |
| Arm V (RER With PD) | 0.70 |
| Arm VI (SER [DECA, ABVE-PC, IFRT]) | 0.79 |
| Arm VII (SER [ABVE-PC, IFRT]) | 0.74 |
Grade 3 or 4 Non-hematologic Toxicity
Occurrence of any grade 4 non-hematologic toxicity or grade 3 non-hematologic toxicity which doesn't respond to treatment within 7 days despite recommended therapy modification, or toxic death, which is any death primarily attributable to treatment. Grade 3 is defined to be severe or medically significant but not immediate life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 refers to toxicities with life-threatening consequences; urgent intervention indicated. (NCT00025259)
Timeframe: Protocol therapy: the overall duration of which is: (n=1684) an average of 137.3 days, median 133.0 days, interquartile range: 101.0, 164.0 days.
| Intervention | Number of participants (Number) |
|---|
| Arm I (Patients Off-therapy Before Callback-Induction Only) | 10 |
| Arm II (RER With CR [ABVE-PC, IFRT]) | 153 |
| Arm III (RER With CR [ABVE-PC]) | 130 |
| Arm IV (RER With Less Than CR [ABVE-PC, IFRT]) | 216 |
| Arm V (RER With PD) | 11 |
| Arm VI (SER [DECA, ABVE-PC, IFRT]) | 62 |
| Arm VII (SER [ABVE-PC, IFRT]) | 45 |
Progression-Free Survival - Independent Review
The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. (NCT00060944)
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
| Intervention | months (Median) |
|---|
| Trabectedin 1.5 mg/m2 | 3.3 |
| Trabectedin 0.58 mg/m2 | 2.3 |
Overall Survival
The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression. (NCT00060944)
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
| Intervention | months (Median) |
|---|
| Trabectedin 1.5 mg/m2 | 13.9 |
| Trabectedin 0.58 mg/m2 | 11.8 |
Duration of Response - Independent Review
Duration of response based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response. (NCT00060944)
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
| Intervention | Months (Median) |
|---|
| Trabectedin 1.5 mg/m2 | 7.5 |
| Trabectedin 0.58 mg/m2 | NA |
Percentage of Participants Objective Response - Independent Review
Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. (NCT00060944)
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
| Intervention | Percentage of participants (Number) |
|---|
| Trabectedin 1.5 mg/m2 | 5.1 |
| Trabectedin 0.58 mg/m2 | 1.5 |
Time to Progression- Independent Review
Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease. (NCT00060944)
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
| Intervention | months (Median) |
|---|
| Trabectedin 1.5 mg/m2 | 3.7 |
| Trabectedin 0.58 mg/m2 | 2.3 |
Comparison of the Increase in Cure Rate of High Risk ALL Without Causing More Serious Side Effects Between Interventions
Event Free Probability. (NCT00075725)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 83.2 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 81.6 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 69.1 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 91.2 |
| Prednisone, Capizzi Methotrexate <10 Years | 82.1 |
| Prednisone, Capezzi Methotrexate >= 10 Years | 73.5 |
| Predisone and High Dose Methotrexate < 10 Yrs Old | 80.8 |
| Prenisone and High Dose Methotrexate >=10 Years | 75.8 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 77.0 |
| Prenisone, Capezzi Methotrexate (Down's Syndrome) | 61.8 |
| Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 44.4 |
Correlation of Early Marrow Response Status With MRD Negative.
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: Day 29
| Intervention | participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 182 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 72 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 198 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 188 |
| Prednisone, Capizzi Methotrexate <10 Years | 195 |
| Prednisone, Capezzi Methotrexate >= 10 Years | 471 |
| Prednisone and High Dose Methotrexate < 10 Yrs Old | 190 |
| Prednisone and High Dose Methotrexate >=10 Years | 479 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 208 |
| Prednisone, Capezzi Methotrexate (Down's Syndrome) | 25 |
| Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 3 |
| Prednisone and High Dose Methotrexate (Non Randomly Assigned) | 18 |
Correlation of Early Marrow Response Status With MRD Positive.
Bone marrow status is defined as: M1: < 5% lymphoblasts; M2: 5-25% lymphoblasts; M3: > 25% lymphoblasts. Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: Day 29
| Intervention | participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 26 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 12 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 43 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 14 |
| Prednisone, Capizzi Methotrexate <10 Years | 16 |
| Prednisone, Capezzi Methotrexate >= 10 Years | 95 |
| Prednisone and High Dose Methotrexate < 10 Yrs Old | 17 |
| Prednisone and High Dose Methotrexate >=10 Years | 98 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 39 |
| Prednisone, Capezzi Methotrexate (Down's Syndrome) | 3 |
| Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 3 |
| Prednisone and High Dose Methotrexate (Non Randomly Assigned) | 3 |
Correlation of Minimal Residual Disease (MRD) Negative With Event Free Survival (EFS).
Bone marrow MRD status is defined as negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 86.4 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 93.6 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 80.5 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 93.1 |
| Prednisone, Capizzi Methotrexate <10 Years | 86.5 |
| Prednisone, Capezzi Methotrexate >= 10 Years | 83.4 |
| Prednisone and High Dose Methotrexate < 10 Yrs Old | 84.2 |
| Prednisone and High Dose Methotrexate >=10 Years | 83.9 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 85.3 |
| Prednisone, Capezzi Methotrexate (Down's Syndrome) | 74.4 |
| Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 25 |
Correlation of Minimal Residual Disease (MRD) Negative With Overall Survival (OS).
Bone marrow MRD status is defined as negative with < .01 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 95.4 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 92.9 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 87.4 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 98.1 |
| Prednisone, Capizzi Methotrexate <10 Years | 93.3 |
| Prednisone, Capizzi Methotrexate >= 10 Years | 90.2 |
| Prednisone and High Dose Methotrexate < 10 Yrs Old | 94.5 |
| Prednisone and High Dose Methotrexate >=10 Years | 90.5 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 91.6 |
| Prednisone, Capizzi Methotrexate (Down's Syndrome) | 78.3 |
| Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random) | 25.0 |
Correlation of Minimal Residual Disease (MRD) Positive With Event Free Survival (EFS)
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 years
| Intervention | percentage of participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 66.5 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 43.3 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 35.4 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 80 |
| Prednisone, Capizzi Methotrexate <10 Years | 34.7 |
| Prednisone, Capizzi Methotrexate >= 10 Years | 39 |
| Prednisone and High Dose Methotrexate < 10 Yrs Old | 55 |
| Prednisone and High Dose Methotrexate >=10 Years | 47.8 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 49.4 |
Correlation of Minimal Residual Disease (MRD) Positive With Overall Survival (OS)
Bone marrow MRD status is defined as positive with >= 0.1 detectable leukemia cells, and negative with < 0.1 detectable leukemia cells. (NCT00075725)
Timeframe: 5 Years
| Intervention | percentage of participants (Number) |
|---|
| Dexamethasone and Capizzi Methotrexate Patients < 10 Years | 79.2 |
| Dexamethasone, High Dose Methotrexate (Non Randomly Assigned) | 69.9 |
| Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old | 65.6 |
| Dexamethasone, High Dose Methotrexate (IM) < 10 Years | 86.2 |
| Prednisone, Capizzi Methotrexate <10 Years | 93.8 |
| Prednisone, Capizzi Methotrexate >= 10 Years | 63.1 |
| Predisone and High Dose Methotrexate < 10 Yrs Old | 84.2 |
| Prednisone and High Dose Methotrexate >=10 Years | 73.6 |
| Dexamethasone, High Dose Methotrexate (IM) >= 10 Years | 74.6 |
Number of Patients With Hematologic Response With Single-agent CC-5013
"Complete response = Absence of detectable monoclonal protein in serum or urine by immunofixation electrophoresis, less than 5% plasma cells on bone marrow biopsy without clonal dominance of kappa or lambda isotype, and normal serum free light chain assay.~Partial response= For patients with detectable and quantifiable monoclonal marrow plasmacytosis= a reduction of 50% or more in plasma cells as a percentage of nucleated bone marrow cells. For patients with a detectable monoclonal peak on serum or urine protein electrophoresis= a reduction in the peak height of 50% or more.~For patients with quantifiable urinary kappa or lambda chain concentration= a 50% reduction in daily light chain excretion in 24 hour urine.~For patients with an elevated serum free light chain assay, a reduction of 50% or more." (NCT00091260)
Timeframe: 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Revlimid | 5 |
Number of Patients Who Received Both CC-5013 and Dexamethasone and Had a Hematologic Response
(NCT00091260)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Revlimid | 26 |
Number of Patients Removed From Study Treatment Due to Toxicities
(NCT00091260)
Timeframe: 1 year
| Intervention | participants (Number) |
|---|
| Revlimid | 31 |
Proportion of Patients With Objective Response (First Phase, Step 1)
"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only." (NCT00098475)
Timeframe: Assessed every 4 weeks for 16 weeks during Step 1
| Intervention | Proportion of patients (Number) |
|---|
| Arm I (Lenalidomide, Dexamethasone) | 0.79 |
| Arm II (Lenalidomide, Low-dose Dexamethasone) | 0.683 |
Proportion of Patients With Objective Response (First Phase, Step 2)
"Objective response is defined as either complete response (CR) or partial response (PR). Patients who have complete disappearance of an M-protein and no evidence of myeloma in the bone marrow are considered to have CR. PR requires all the following: (1) ≥50% reduction in the level of the serum monoclonal paraprotein. (2) Reduction in 24-hour urinary light chain excretion either by ≥90% or to <200 mg. (3)For patients with non-secretory (or oligosecretory) myeloma only, a ≥50% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy must be documented. (4)50% reduction in size of soft tissue plasmacytoma (by radiography or clinical examination). (5) No increase in the number or size of lytic bone lesions (development of a compression fracture does not exclude response).~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only." (NCT00098475)
Timeframe: Assessed every 4 weeks for 16 weeks during Step 2
| Intervention | Proportion of patients (Number) |
|---|
| Arm I (Lenalidomide, Dexamethasone) | 0 |
| Arm II (Lenalidomide, Low-dose Dexamethasone) | 0 |
Event-free Survival (EFS) for SR-Low Patients
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: 6 years
| Intervention | Percent probability (Number) |
|---|
| SR-low ALL, Arm I-combination Chemotherapy | 95.22 |
| SR-low ALL, Arm II-combination Chemotherapy | 93.96 |
Event-Free Survival Probability According to MRD Status End Induction (Day 29)
Event-Free survival by Day 29 MRD status (negative vs positive), Event Free Probability (time from study entry to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: MRD at Day 29 of therapy
| Intervention | Percent Probability (Number) |
|---|
| Induction Therapy, MRD Negative | 91.39 |
| Induction Therapy, MRD Positive | 79.86 |
Event-free Survival (EFS) for SR-Average ALL Patients
EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: 6 years
| Intervention | percent probability (Number) |
|---|
| Standard and Intensified therapy | Standard therapy |
|---|
| Group 2-SR-avg ALL, Arm I-combination Chemotherapy | 83.82 | 87.41 |
,| Group 2-SR-avg ALL, Arm II-combination Chemotherapy | 88.89 | 88.29 |
Event-free Survival (EFS) for SR-Average ALL Patients
EFS for SR-Average with standard and Intensified Consolidation. Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: 6 years
| Intervention | percent probability (Number) |
|---|
| Standard and Intensified therapy |
|---|
| Group 2-SR-avg ALL, Arm III-combination Chemotherapy | 88.34 |
,| Group 2-SR-avg ALL, Arm IV-combination Chemotherapy | 90.51 |
Overall Survival Probability (OS) According to Induction Day 29 MRD Status
Overall survival by Day 29 MRD status (negative vs positive), Overall survival defined as time from study entry to death or date of last contact for patients who are alive. (NCT00103285)
Timeframe: Overall Survival Probability of 6 years
| Intervention | percent probability (Number) |
|---|
| Induction Therapy, MRD Negative | 97.07 |
| Induction Therapy, MRD Positive | 90.47 |
Event-free Survival (EFS) for SR-High Patients.
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: 6 years
| Intervention | percent probability (Number) |
|---|
| Group 3-SR-high ALL, Combination Chemotherapy | 85.58 |
Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)
Event-free probability where EFS is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00103285)
Timeframe: 6 years
| Intervention | Percent probability (Number) |
|---|
| Group 1-SR-low ALL, Arm I-combination Chemotherapy | 95.22 |
| Group 2-SR-avg ALL, Arm I-combination Chemotherapy | 88.52 |
Early Marrow Status (EMS) by MRD Status End Induction (Day 29)
Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative) (NCT00103285)
Timeframe: Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.
| Intervention | Participants (Count of Participants) |
|---|
| All Patients for Induction, MRD Negative | 4378 |
| All Patients for Induction, MRD Positive | 258 |
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented. (NCT00168298)
Timeframe: Day 180
| Intervention | Number of Participants (Number) |
|---|
| 700 µg Dexamethasone | 53 |
| 350 µg Dexamethasone | 48 |
| Sham Injection | 38 |
Change From Baseline in Retinal Thickness in the Study Eye
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement. (NCT00168298)
Timeframe: Baseline, Day 90, Day 180
| Intervention | Microns (µm) (Mean) |
|---|
| Baseline | Change from Baseline at Day 90 | Change from Baseline at Day 180 |
|---|
| 350 µg Dexamethasone | 566.6 | -205.5 | -150.5 |
,| 700 µg Dexamethasone | 573.6 | -215.6 | -132.1 |
,| Sham Injection | 542.5 | -91.1 | -127.4 |
Percentage of Patients With a Change From Baseline in BCVA by Category
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening. (NCT00168298)
Timeframe: Baseline, Day 180
| Intervention | Percentage of Patients (Number) |
|---|
| ≥15 Letters Improvement | ≥5 and <15 Letters Improvement | No Change (Between -5 to +5 Letters) | ≥5 and <15 Letters Worsening | ≥15 Letters Worsening |
|---|
| 350 µg Dexamethasone | 21.6 | 33.9 | 28.9 | 10.6 | 5.0 |
,| 700 µg Dexamethasone | 23.5 | 35.0 | 27.0 | 8.0 | 6.6 |
,| Sham Injection | 17.0 | 28.6 | 28.6 | 13.8 | 12.1 |
Percentage of Patients With a Change From Baseline in BCVA by Category
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening. (NCT00168298)
Timeframe: Baseline, Day 90
| Intervention | Percentage of Patients (Number) |
|---|
| ≥15 Letters Improvement | ≥5 and <15 Letters Improvement | No Change (Between -5 to +5 Letters) | ≥5 and <15 Letters Worsening | ≥15 Letters Worsening |
|---|
| 350 µg Dexamethasone | 25.7 | 39.0 | 26.6 | 6.4 | 2.3 |
,| 700 µg Dexamethasone | 21.2 | 45.1 | 25.7 | 4.4 | 3.5 |
,| Sham Injection | 13.8 | 37.1 | 29.9 | 11.2 | 8.0 |
Percentage of Patients With a Change From Baseline in BCVA by Category
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening. (NCT00168324)
Timeframe: Baseline, Day 180
| Intervention | Percentage of Patients (Number) |
|---|
| ≥15 Letters Improvement | ≥5 and <15 Letters Improvement | No Change (Between -5 to +5 Letters) | ≥5 and <15 Letters Worsening | ≥15 Letters Worsening |
|---|
| 350 µg Dexamethasone | 16.3 | 37.8 | 25.5 | 10.7 | 9.7 |
,| 700 µg Dexamethasone | 19.4 | 34.8 | 29.4 | 10.9 | 5.5 |
,| Sham Injection | 18.3 | 27.7 | 30.2 | 14.9 | 8.9 |
Percentage of Patients With a Change From Baseline in BCVA by Category
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. Data are grouped into the following 5 categories based on change from baseline: ≥15 Letters Improvement, ≥5 and <15 Letters Improvement, No Change (Between -5 to +5 Letters), ≥5 and <15 Letters Worsening, and ≥15 Letters Worsening. (NCT00168324)
Timeframe: Baseline, Day 90
| Intervention | Percentage of Patients (Number) |
|---|
| ≥15 Letters Improvement | ≥5 and <15 Letters Improvement | No Change (Between -5 to +5 Letters) | ≥5 and <15 Letters Worsening | ≥15 Letters Worsening |
|---|
| 350 µg Dexamethasone | 20.9 | 42.3 | 23.5 | 9.2 | 4.1 |
,| 700 µg Dexamethasone | 22.4 | 39.8 | 27.4 | 7.0 | 3.5 |
,| Sham Injection | 12.4 | 34.2 | 34.7 | 13.4 | 5.4 |
Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye
BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye at each visit are presented. (NCT00168324)
Timeframe: Day 90, Day 180
| Intervention | Number of Participants (Number) |
|---|
| Day 90 | Day 180 |
|---|
| 350 µg Dexamethasone | 41 | 32 |
,| 700 µg Dexamethasone | 45 | 39 |
,| Sham Injection | 25 | 37 |
Change From Baseline in Retinal Thickness in the Study Eye
Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative change from baseline indicates an improvement. (NCT00168324)
Timeframe: Baseline, Day 90, Day 180
| Intervention | Microns (µm) (Mean) |
|---|
| Baseline | Change from Baseline at Day 90 | Change from Baseline at Day 180 |
|---|
| 350 µg Dexamethasone | 541.6 | -144.1 | -91.4 |
,| 700 µg Dexamethasone | 548.9 | -199.3 | -105.0 |
,| Sham Injection | 534.4 | -78.2 | -110.3 |
Cumulative Response Rate of 15 or More Letter Improvement
The cumulative response rate of 15 or more letter improvement was based on the Kaplan-Meier estimate. A Kaplan-Meier analysis takes into account patients who dropped out from the study prior to achieving the 15 letter improvement. Values ranged from 0-1, with a higher number indicating a higher probability of response. (NCT00168324)
Timeframe: Up to 180 Days
| Intervention | Kaplan-Meier Estimate (Number) |
|---|
| Day 30 | Day 60 | Day 90 | Day 180 |
|---|
| 350 µg Dexamethasone | 0.092 | 0.204 | 0.292 | 0.349 |
,| 700 µg Dexamethasone | 0.101 | 0.258 | 0.359 | 0.397 |
,| Sham Injection | 0.045 | 0.100 | 0.165 | 0.225 |
Overall Survival (OS)
OS is measured from the start of on-study to the date of death or to the last date of follow-up. Measurement is determined by Kaplan-Meyer estimate. The probability of survival at 5 years after diagnosis is given. (NCT00186875)
Timeframe: 2 years after last patient completes therapy (approximately 4 years after enrollment)
| Intervention | probability (Mean) |
|---|
| Standard Risk | 0.654 |
| High Risk | 0.357 |
Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)
The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block B is defined as the proportion of MRD positives. (NCT00186875)
Timeframe: End of Block B therapy (Day 19)
| Intervention | Participants (Count of Participants) |
|---|
| Negative <0.01% | Positive ≥0.01% |
|---|
| High Risk | 2 | 10 |
,| Standard Risk | 11 | 11 |
,| TOTXV Participants | 191 | 297 |
Minimal Residual Disease (MRD) Compared With Historical Data From TOTXV Protocol (NCT00137111)
The prevalence of MRD in children undergoing treatment for relapsed ALL and to compare the results to those obtained in children with newly diagnosed ALL. MRD is considered as positive (i.e., prevalent) if its level is >=0.01%. The prevalence of MRD after Block C is defined as the proportion of MRD positives. (NCT00186875)
Timeframe: End of Block Block C therapy (Day 46)
| Intervention | Participants (Count of Participants) |
|---|
| Negative <0.01% | Positive ≥0.01% |
|---|
| High Risk | 1 | 8 |
,| Standard Risk | 11 | 9 |
,| TOTXV Participants | 390 | 102 |
Response Rate
"The response rate is defined as the proportion of participants who attain morphological complete remission after the re-induction Block C, inclusive of all patients who begin re-induction. Morphological complete remission was defined as <5% blasts in bone marrow by morphology." (NCT00186875)
Timeframe: End of re-induction Block C (approximately 1 month after the start of therapy)
| Intervention | proportion of participants (Number) |
|---|
| Complete remission | Failure to reach complete remission |
|---|
| High Risk | 0.786 | 0.214 |
,| Standard Risk | 0.846 | 0.154 |
Number of Participants With Adverse Events
This outcome measure was to assess the safety and tolerability of bortezomib, dexamethasone and rituximab in patients with untreated Waldenstroms macroglobulinemia. (NCT00250926)
Timeframe: 33.2 months
| Intervention | participants (Number) |
|---|
| Bortezomib, Dexamethasone, Rituximab | 23 |
Response Rate
"This outcome measure was to determine the response rate along with attainment of stable disease and time to disease progression following treatment with this patient population. The response rates were defined as follows.~A complete response (CR) was defined as having resolution of all symptoms, normalization of serum IgM levels with complete disappearance of IgM paraprotein by immunofixation, absence of bone marrow disease by bone marrow biopsy and aspiration, and resolution of any adenopathy or splenomegaly. A near complete response (nCR) was defined as fulfilling all CR criteria in the presence of a positive immunofixation study. Patients with very good partial response (VGPR), partial response (PR), and minor response (MR) were defined as having a ≥ 90%, ≥ 50%, and 25% to 49% reduction in serum IgM levels, respectively. Progressive disease (PD) occurred when a more than 25% increase in serum IgM level or progression of clinically significant disease parameters was observed." (NCT00250926)
Timeframe: 33.2 months
| Intervention | participants (Number) |
|---|
| Complete Response (CR) | Near Complete Response (nCR) | Very Good Partial Response (VGPR) | Partial Response (PR) | Minor Response (MR) | Stable Disease |
|---|
| Bortezomib, Dexamethasone, Rituximab | 3 | 2 | 3 | 11 | 3 | 1 |
Time to Progression
Progressive Disease (PD) will be defined as a greater than 25% increase in serum IgM monoclonal protein levels from the lowest attained response value as determined by serum electrophoresis, confirmed by at least one other investigation, or progression of clinically significant disease related symptom(s). (NCT00250926)
Timeframe: 42 months
| Intervention | months (Median) |
|---|
| Bortezomib, Dexamethasone, Rituximab | NA |
Time to Best Response
(NCT00250926)
Timeframe: 33.2 months
| Intervention | Months (Median) |
|---|
| Bortezomib, Dexamethasone, Rituximab | 15 |
Toxicity Grade 3, 4, or 5
(NCT00293384)
Timeframe: at 0-120 hours
| Intervention | participants (Number) |
|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | 2 |
Proportion of Participants With Controlled Acute Vomiting
No episodes of vomiting and no rescue medication during first 24 hours after cyclophosphamide administration. (NCT00293384)
Timeframe: at 0-24 hours
| Intervention | participants (Number) |
|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | 20 |
Overall Nausea Controlled
(NCT00293384)
Timeframe: at 0-120 hours
| Intervention | participants (Number) |
|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | 31 |
Delayed Vomiting Controlled
(NCT00293384)
Timeframe: at 25-120 hours
| Intervention | participants (Number) |
|---|
| Aprepitant, Dexamethasone, Cytoxan & Kytril | 22 |
Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)
Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved. (NCT00333814)
Timeframe: Week 8
| Intervention | Percentage of Patients (Number) |
|---|
| Dexamethasone 350 µg | 39.5 |
| Dexamethasone 700 µg | 42.9 |
| Sham | 6.6 |
Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe). (NCT00333814)
Timeframe: Week 8
| Intervention | Percentage of Patients (Number) |
|---|
| Dexamethasone 350 µg | 35.5 |
| Dexamethasone 700 µg | 46.8 |
| Sham | 11.8 |
Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score
Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality). (NCT00333814)
Timeframe: Week 8
| Intervention | Percentage of Patients (Number) |
|---|
| Dexamethasone 350 µg | 40.8 |
| Dexamethasone 700 µg | 50.7 |
| Sham | 15.9 |
Complete Response Rate - Locally Reviewed
"Assessed by the ECOG-ACRIN data manager based upon local review of images and data sent by the local sites.~Treatment response was determined by calculating the sum of the maximal cross section in 2 separate axes using enhancing lesion(s) on CT or MRI imaging. The same imaging modality was to be used throughout assessment. Complete response was defined as the disappearance of all contrast enhancing tumor size on CT or MRI, patient was off all glucocorticoids, and resolution of all meningeal and vitreous involvement if present. Response must have lasted at least 4 weeks." (NCT00335140)
Timeframe: For the primary endpoint, complete response will be based on disease status at three weeks post the end of therapy (week 17).
| Intervention | percentage of participants (Number) |
|---|
| Rituximab + Standard Chemotherapy | 64 |
Number of Patients Who Reported No Vomiting
"The number of patients who reported No Vomiting in the overall phase in Cycle~1" (NCT00337727)
Timeframe: Overall phase (0-120 hours post initiation of MEC) in Cycle 1.
| Intervention | Participants (Number) |
|---|
| Aprepitant Regimen | 324 |
| Standard Regimen | 252 |
Number of Patients Who Reported Complete Response
The number of patients who reported Complete Response (no vomiting and no use of rescue medication) in the overall phase in Cycle 1. (NCT00337727)
Timeframe: Overall phase (0-120 hours post initiation of MEC) in Cycle 1
| Intervention | Participants (Number) |
|---|
| Aprepitant Regimen | 292 |
| Standard Regimen | 229 |
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| ARM I (Combination Chemotherapy) | 89.01 |
| ARM II (Combination Chemotherapy) | 90.53 |
| ARM III (Combination Chemotherapy) | 78.07 |
| ARM IV (Combination Chemotherapy) | 86.46 |
Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| Low Risk | Intermediate Risk | High Risk |
|---|
| ARM I (Combination Chemotherapy) | 1.85 | 1.16 | 3.64 |
,| ARM III (Combination Chemotherapy) | 1.92 | 9.1 | 6.52 |
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I vs. Arm II vs. Arm III vs. Arm IV)
Disease-free survival defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, remission death) or date of last contact for those who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| ARM I (Combination Chemotherapy) | 91.76 |
| ARM II (Combination Chemotherapy) | 90.53 |
| ARM III (Combination Chemotherapy) | 86.06 |
| ARM IV (Combination Chemotherapy) | 84.89 |
Disease-free Survival (DFS) for Randomized Methotrexate T-ALL Cohort (Arm I + Arm II vs. Arm III + Arm IV)
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| ARM I and ARM II (Combination Chemotherapy) | 91.45 |
| ARM III and ARM IV (Combination Chemotherapy) | 85.78 |
Cumulative Incidence of CNS Relapse for T-ALL by Risk Group
Cumulative incidence of CNS relapse adjusting for DFS events, was calculated using the method Gray et. al. High risk patients receive cranial radiation and low risk patients receive no cranial radiation. (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| Intermediate Risk | High Risk |
|---|
| ARM II (Combination Chemotherapy) | 1.08 | 0 |
,| ARM IV (Combination Chemotherapy) | 0.85 | 3.45 |
Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from end of induction
| Intervention | percent probability (Number) |
|---|
| High Risk | Induction Failure |
|---|
| ARM II (Combination Chemotherapy) | 85.0 | 100 |
Disease-free Survival (DFS) for T-cell Lymphoblastic Lymphoma (T-LLy) Cohort
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. (NCT00408005)
Timeframe: 4 years from end of induction
| Intervention | percent probability (Number) |
|---|
| Standard Risk | High Risk |
|---|
| ARM I (Combination Chemotherapy) | 87.4 | 85.1 |
Disease-free Survival (DFS) for Randomized Nelarabine T-ALL Cohort (Arm I + Arm III vs. Arm II + Arm IV)
Disease Free Probability where DFS time is defined as time from randomization end of induction to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event (NCT00408005)
Timeframe: 4 years from randomization at the end of induction
| Intervention | percent probability (Number) |
|---|
| ARM I and ARM III (Combination Chemotherapy) | 82.96 |
| ARM II and ARM IV (Combination Chemotherapy) | 88.30 |
Palonosetron Response Rate in the 10 Day Study Cycle
Number of participants with dose of palonosetron who experienced response (no emesis) during acute and delayed time period of the study (10 days) divided by number of participants. Complete response defined as no emesis and no rescue medicines in 10 days from the start of chemotherapy in the first chemotherapy cycle. (NCT00410488)
Timeframe: 10 days
| Intervention | percentage of participants (Number) |
|---|
| Palonosetron - 1 Dose | 31.25 |
| Palonosetron - 3 Doses | 50 |
Summary of Myeloma Response Rates Based on Best Response Assessment
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma. (NCT00424047)
Timeframe: Randomization to 03 August 2005; up to 24 months
| Intervention | percentage of participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluable (NE) those without response data |
|---|
| Lenalidomide Plus Dexamethasone | 15.3 | 43.8 | 29.0 | 2.8 | 9.1 |
,| Placebo Plus Dexamethasone | 4.0 | 19.4 | 56.6 | 14.3 | 5.7 |
Kaplan-Meier Estimate of Time to Tumor Progression (TTP) (Later Cut-off Date of 02 Mar 2008)
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia. (NCT00424047)
Timeframe: From randomization up to cut-off date of 02 March 2008; up to 51 months
| Intervention | weeks (Median) |
|---|
| Lenalidomide Plus Dexamethasone | 52.4 |
| Placebo Plus Dexamethasone | 20.1 |
Myeloma Response Rates Based on the Reviewers Best Response Assessment (Later Cut-off Date of 02 March 2008)
Complete Response (CR): Disappearance of monoclonal paraprotein and maintained for ≥ 6 weeks . Remission Response (RR):75-99% reduction in the level of the serum monoclonal paraprotein compared to baseline; 90-99% reduction in 24-hr urinary light chain excretion. Partial Response (PR): 50-74% reduction in the level of monoclonal paraprotein compared to baseline; 50-89% reduction in 24-hr urinary light chain excretion. Stable Disease (SD): Criteria for PR or PD have not been met. Plateau Phase: If PR, stable monoclonal paraprotein values (within 25% above or below nadir)/stable soft tissue plasmacytomas maintained for at least 3 months. Progressive Disease (PD): Reappearance of serum or urinary monoclonal paraprotein on immunofixation or electrophoresis on two consecutive occasions at least one week apart. Increase of percentage of plasma cells in bone marrow aspirate or biopsy to ≥ 5%. Development of at least one new lytic bone lesion or soft tissue plasmacytoma. (NCT00424047)
Timeframe: Randomization to data cut-off of 02 Mar 2008; up to 51 months
| Intervention | percentage of participants (Number) |
|---|
| Complete Response (CR) | Partial Response (PR) | Stable Disease (SD) | Progressive Disease (PD) | Not Evaluable (NE) those without response data |
|---|
| Lenalidomide Plus Dexamethasone | 17.0 | 42.6 | 28.4 | 3.4 | 8.5 |
,| Placebo Plus Dexamethasone | 4.0 | 19.4 | 56.6 | 14.3 | 5.7 |
Number of Participants With Adverse Events (AE)
"An AE is any sign, symptom, illness, or diagnosis that appears or worsens during the course of the study. Treatment-emergent AEs (TEAEs) are any AE occurring or worsening on or after the first treatment of the study drug and within 30 days after the last cycle end date of study drug. A serious AE = any AE which results in death; is life-threatening; requires or prolongs existing inpatient hospitalization; results in persistent or significant disability is a congenital anomaly/birth defect; constitutes an important medical event.~The severity of AEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE, Version 2.0): Grade 1 = Mild (no limitation in activity or intervention required); Grade 2 = Moderate (some limitation in activity; no/minimal medical intervention required); Grade 3 = Severe (marked limitation in activity; medical intervention required, hospitalization possible); Grade 4 = Life-threatening; Grade 5 = Death." (NCT00424047)
Timeframe: From first dose of study drug through to 30 days after the last dose, until the data cut-off date of 25 June 2013; up to 90 months
| Intervention | participants (Number) |
|---|
| ≥ 1 Adverse Event | ≥ 1 Serious Adverse Event | ≥ 1 AE leading to study drug discontinuation | ≥ 1 AE leading to dose reduction or interruption | ≥ 1 Drug-Related Adverse Event | ≥ 1 Drug-Related Serious Adverse Event | ≥Death within ≤ 30 days of last dose of study drug | ≥ 1 Grade 1 or Higher Adverse Event | ≥ 1 Grade 2 or Higher Adverse Event | ≥ 1 Grade 3 or Higher Adverse Event | ≥ 1 Grade 4 or Higher Adverse Event |
|---|
| Lenalidomide Plus Dexamethasone | 176 | 105 | 46 | 137 | 160 | 54 | 17 | 176 | 168 | 146 | 52 |
,| Placebo Plus Dexamethasone | 175 | 79 | 31 | 100 | 151 | 30 | 20 | 175 | 167 | 119 | 37 |
Kaplan-Meier Estimate of Overall Survival (OS) (Later Cut-off Date of 02 March 2008)
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. (NCT00424047)
Timeframe: Randomization to data cut off of 02 March 2008; up to 51 months
| Intervention | weeks (Median) |
|---|
| Lenalidomide Plus Dexamethasone | 161.9 |
| Placebo Plus Dexamethasone | 133.3 |
Kaplan-Meier Estimate of Time to Tumor Progression (TTP)
Time to progression was calculated as the time from randomization to the first occurrence of disease progression, as determined by a detailed review of all the myeloma response assessment data using the Bladé criteria (Bladé, 1998). Disease progression was also based on bone marrow findings, worsening lytic bone disease, progressively enlarging extramedullary plasmacytomas, or hypercalcemia. (NCT00424047)
Timeframe: From randomization up to cut-off date of 03 August 2005; up to 24 months
| Intervention | weeks (Median) |
|---|
| Lenalidomide Plus Dexamethasone | 52.1 |
| Placebo Plus Dexamethasone | 20.1 |
Kaplan-Meier Estimate of Overall Survival (OS)
OS was calculated as the time from randomization to death from any cause. OS was censored at the last date that the participant was known to be alive for participants who were alive at the time of analysis and for participants who were lost to follow-up before death was documented. (NCT00424047)
Timeframe: Randomization to data cut off of 03 August 2005; up to 24 months
| Intervention | weeks (Median) |
|---|
| Lenalidomide Plus Dexamethasone | NA |
| Placebo Plus Dexamethasone | NA |
Kaplan-Meier Estimate of Duration of Response (Cut-off at a Later Date of 03 March 2008)
Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression. (NCT00424047)
Timeframe: Up to data cut off of 03 Mar 2008; up to 51 months
| Intervention | weeks (Median) |
|---|
| Lenalidomide Plus Dexamethasone | 68.1 |
| Placebo Plus Dexamethasone | 33.3 |
Kaplan-Meier Estimate of Duration of Response
Duration of response was calculated for responders and defined as the time from the first observation of a response (e.g., the first time that the appropriate decrease in M-protein level was observed for confirmed responders) to the first documented progression or relapse. Response duration was censored at the last adequate assessment showing evidence of no progression. (NCT00424047)
Timeframe: Up to data cut off of 03 August 2005; up to 24 months
| Intervention | weeks (Median) |
|---|
| Lenalidomide Plus Dexamethasone | 67.6 |
| Placebo Plus Dexamethasone | 33.3 |
Time to Disease Progression
International Myeloma Working Group Uniform Response Criteria was used (NCT00445692)
Timeframe: Up to 10.25 years
| Intervention | months (Median) |
|---|
| Treatment (Clarithromycin, Dexamethasone, Lenalidomide) | 30.5 |
Episodes of Grade 3-4 Non Infectious, Non-dermatological or Non-neurological Toxicities, Episodes of Any Infections, Grade 3-4 Dermatological or Episodes of Grade 2-3 Peripheral Neuropathy Common Terminology Criteria for Adverse Events Version 3
(NCT00445692)
Timeframe: First year of therapy
| Intervention | episodes (Number) |
|---|
| Neutropenia | Thrombocytopenia | Deep venous thrombus/Pulmonary Embolism | Anemia | Pneumonia | Upper respiratory infections | Sinusitis/acute otitis media | Epiglottic appendagitis | Cellulitis | Clostridium difficile colitis | Vaginitis | Peripheral neuropathy | Dermal leukocytic vasculitis | Secondary cancer Acute Myeloid Leukemia | Re-occurrence of skin cancer |
|---|
| Treatment (Clarithromycin, Dexamethasone, Lenalidomide) | 6 | 1 | 1 | 1 | 4 | 12 | 3 | 1 | 3 | 1 | 3 | 10 | 1 | 1 | 1 |
Time to Failure (Phase II)
Failure will be defined as recurrence/progression of disease or death from either disease or toxicity. Bayesian toxicity monitoring schema will be used to monitor severe toxicity profile in combined therapy. Severe toxicity is defined as at least two episodes of neutropenic fever during treatment courses. (NCT00477412)
Timeframe: First date of diagnosis up to 5 years
| Intervention | months (Median) |
|---|
| Phase II- Treatment (Combination Chemotherapy) | 55 |
Overall Survival
Overall survival is the time in number of months from start of study treatment to date of death due to any cause. (NCT00477412)
Timeframe: Date of diagnosis to last known date of survival, up to 5 years
| Intervention | months (Median) |
|---|
| Phase II- Treatment (Combination Chemotherapy) | 44 |
Number of Participants With Overall Response Rate
Response rate is determined by CT scans of the chest, abdomen, and pelvis, unilateral BM biopsy and aspirate with lymphoma markers (if initially positive) and colonoscopy/endoscopy if applicable. (NCT00477412)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Phase II- Treatment (Combination Chemotherapy) | 87 |
Maximum Tolerated Dose of Bortezomib (Phase I)
Determine the safety and the maximum tolerated dose (MTD) of bortezomib when added to the combination of rituximab, methotrexate, and cytarabine alternating with bortezomib, rituximab-hyperCVAD in patients with untreated aggressive mantle cell lymphoma. (NCT00477412)
Timeframe: Cycle 1 Day 1 - End of Cycle 2 up to 60 days.
| Intervention | mg/m^2 (Number) |
|---|
| Phase 1 Maximum Tolerated Dose (MTD) | 1.3 |
Overall Survival
time from day of registration until day of death. (NCT00520767)
Timeframe: time from day of registration until 72 months.
| Intervention | month (Median) |
|---|
| Melphalan, Dexamethasone, Bortezomib, | 31.1 |
Time to Treatment Failure (TTF)
Time from start of treatment until date of documented disease progression, removal from protocol due to toxicity, or death from any cause. (NCT00520767)
Timeframe: start of treatment until 72 months
| Intervention | month (Median) |
|---|
| Melphalan, Dexamethasone, Bortezomib, | 18.1 |
Complete Hematologic Response
(NCT00520767)
Timeframe: Up to 12 months
| Intervention | participants (Number) |
|---|
| Melphalan, Dexamethasone, Bortezomib, | 16 |
Percent of Particpants Achieving Overall Combined Complete Response (CR) Following Induction
"Percent of Particpants Achieving Overall combined complete response (CR w/normalized serum κ:λ ratio + CR + near complete response (nCR)) following induction therapy.~CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~κ:λ ratio: normal free light chain (FLC) ratio~nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow." (NCT00531453)
Timeframe: all data included in clinical database as of 10 April 2009
| Intervention | percentage of participants (Number) |
|---|
| Three Drug Regimen (VDT) | 51 |
| Four Drug Regimen (VDTC) | 44 |
Percent of Participants Achieving Overall Combined Complete Response (CR) Following High-dose Chemotherapy (HDT)/Stem Cell Transplantation (SCT)
"Percent of Participants Achieving Overall Combined Complete Response (CR) (CR w/normalized serum κ:λ ratio + CR + Near Complete Response (nCR)) following stem cell transplantation.~CR criteria: negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow.~κ:λ ratio: normal free light chain (FLC) ratio~nCR criteria: positive immunofixation analysis of serum or urine as the only evidence of disease; disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow." (NCT00531453)
Timeframe: all data included in clinical database as of 10 April 2009
| Intervention | percentage of participants (Number) |
|---|
| Three Drug Regimen (VDT) | 76 |
| Four Drug Regimen (VDTC) | 78 |
Proportion of Participants With Minimal Residual Disease (MRD) at End of Remission Induction ≥ 0.01%
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol. (NCT00549848)
Timeframe: End of remission induction; day 42 in Total XVI and day 46 in Total XV
| Intervention | Participants (Count of Participants) |
|---|
| TOTXVI PEG 3500 | 7 |
| TOTXVI PEG 2500 | 12 |
| TOTXVI Not Randomized | 20 |
| All Eligible Patients in TOTXV | 44 |
Percentage of Participants With Continuous Complete Remission of Patients Receiving High-dose and Conventional Dose PEG-asparaginase.
"The primary objective of this study is to compare the distributions of continuous complete remission of patients randomized on the first day of the continuation phase to receive a higher dose of PEG-asparaginase or to receive the conventional dose (2,500 units/m2).~The randomization will occur on the starting day of the continuation phase, at which time all information necessary for performing the randomization should be available. In the rare case that immunophenotype and/or Day-15 MRD is not available, we will make the following assumptions: If immunophenotype is unknown at the time the randomization is to be executed, then it will be assumed B-lineage. If Day-15 MRD is unknown at the time of randomization, then it will be assumed negative (<0.01%). Past experience indicate that few patients will fall into these unknown categories." (NCT00549848)
Timeframe: 3.5 years after the last enrollment up to 12.5 years
| Intervention | Percentage of participants (Number) |
|---|
| PEG 3500 Units/m^2 | 91.6 |
| PEG 2500 Units/m^2 | 90.7 |
Probability of CNS Relapse
To assess whether intensification of CNS-directed intrathecal and systemic chemotherapy will improve outcome in patients at high-risk of CNS relapse. (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
| Intervention | Percentage of participants (Number) |
|---|
| TOTXVI PEG 3500 | 0.8 |
| TOTXVI PEG 2500 | 1.8 |
| TOTXVI Not Randomized | 2.7 |
| All Eligible Patients in TOTXV | 5.7 |
Proportion of Participants With Minimal Residual Disease (MRD) on the 15th Day of Remission Induction ≥ 5%
To study whether intensifying induction, including fractionated cyclophosphamide and thioguanine, in patients with day 15 MRD ≥ 5% will result in improved leukemia cytoreduction in this subgroup compared to therapy followed in the TOTXV protocol. (NCT00549848)
Timeframe: Middle of remission induction, Day 15 in Total XVI and Day 19 in Total XV
| Intervention | Participants (Count of Participants) |
|---|
| TOTXVI PEG 3500 | 22 |
| TOTXVI PEG 2500 | 26 |
| TOTXVI Not Randomized | 31 |
| All Eligible Patients in TOTXV | 55 |
Probability of Overall Survival
To estimate the overall survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV. (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
| Intervention | Percentage of participants (Number) |
|---|
| TOTXVI PEG 3500 | 97.5 |
| TOTXVI PEG 2500 | 95.6 |
| TOTVI Not Randomized | 90.8 |
| All Eligible Patients in TOTXV | 93.5 |
Probability of Event-free Survival
"To estimate the event-free survival of children with ALL who are treated with risk-directed therapy and to compare the EFS results of TOTXVI with that of TOTXV (NCT00137111).~EFS will be measured from the date of complete response to the date of initial failure for patients who fail. Failure includes the traditional endpoints of failure to achieve a complete remission, relapse in any site, secondary malignancy, and death during induction or remission. EFS time will be measured to the date of last contact for patients who are failure free at the time of analysis. The EFS time is defined to be zero (0) for patients who die during induction therapy or fail to achieve a complete remission." (NCT00549848)
Timeframe: For Total XVI: 3.5 years after the last enrollment, up to approximately 13.5 years For Total XV: patients are followed continuously, up to 20.5 years
| Intervention | Percentage of participants (Number) |
|---|
| TOTXVI PEG 3500 | 92.4 |
| TOTXVI PEG 2500 | 91.1 |
| TOTXVI Not Randomized | 86.3 |
| All Eligible Patients in TOTXV | 87.1 |
Percent Probability for Event-free Survival (EFS) of MLL-R Infants Treated With Combination Chemotherapy With or Without Lestaurtinib at DL2
Event Free Probability where EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. EFS will be compared between patients on treatment Arm C at DL2 to those on Arm B. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years.
| Intervention | percent probability (Number) |
|---|
| Arm B (IR/HR MLL-R Chemotherapy) | 38.89 |
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 35.82 |
Percent Probability of Event Free Survival (EFS) by MRD Status and Treatment Arm
Three-year EFS estimates and 90% CI will be reported by treatment arm and end-induction MRD status. (NCT00557193)
Timeframe: 3 Years from end of Induction)
| Intervention | percent probability (Number) |
|---|
| Arm A (MRD Negative) | 86.05 |
| Arm A (MRD Positive) | 87.5 |
| Arm B (MRD Negative) | 47.37 |
| Arm B (MRD Positive) | 22.73 |
| Arm C (MRD Negative) | 51.85 |
| Arm C (MRD Positive) | 27.03 |
Pharmacodynamics PIA Levels in Infants Given Lestaurtinib at DL2 in Combination With Chemotherapy
Summarized with mean and standard deviation for those with available data in Arm C (NCT00557193)
Timeframe: Sampled between weeks 6-12 from start of induction
| Intervention | Activity percentage (Mean) |
|---|
| Arm C (Safety/Efficacy Dose Level 2) | 69.00 |
Describe in Vitro Sensitivity as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in samples which have acquired resistance to lestaurtinib (NCT00557193)
Timeframe: At relapse (up to 3 years)
| Intervention | Proportion of cells that are viable (Mean) |
|---|
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 0.69 |
Describe FLT3 Protein Expression as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
Described via mean and standard deviation by group. (NCT00557193)
Timeframe: Sampled at the start of induction
| Intervention | qPCR fold expression ratio (Mean) |
|---|
| Arm A (Standard Risk MLL-G) | 1.25 |
| Arm B (IR/HR MLL-R Chemotherapy) | 7.85 |
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 5.83 |
Describe FLT3 Protein Expression as a Molecular Mechanism of Acquired Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in available Arm C relapse samples (NCT00557193)
Timeframe: At relapse (up to 3 years)
| Intervention | qPCR fold expression ratio (Mean) |
|---|
| Arm C (Safety/Efficacy Dose Level 2) | 5.73 |
Percent Probability for Event-free Survival (EFS) for Patients on Arm A
EFS time is defined as time from treatment assignment to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years
| Intervention | percentage probability (Number) |
|---|
| Arm A (Standard Risk MLL-G) | 86.67 |
Percent Probability for Event-free Survival (EFS) for Patients on Arm C at Dose Level 2 (DL2)
EFS time is defined as time from randomization to first event (relapse, second malignant neoplasm, death) or date of last contact for patients who are event-free. EFS is constructed using the Kaplan-Meier life table method with confidence interval based on standard errors computed using the method of Peto and Peto. (NCT00557193)
Timeframe: From start of post-induction therapy for up to 10 years
| Intervention | percentage probability (Number) |
|---|
| Arm C (Safety/Efficacy Dose Level 2) | 35.82 |
Describe in Vitro Sensitivity as a Molecular Mechanism of Primary Resistance to Lestaurtinib in Leukemic Blasts
Described via means and standard deviations in samples which have primary resistance to lestaurtinib (NCT00557193)
Timeframe: Sampled at the start of induction
| Intervention | Proportion of cells that are viable (Median) |
|---|
| Arm A (Standard Risk MLL-G) | 0.75 |
| Arm B (IR/HR MLL-R Chemotherapy) | 0.48 |
| Arm C (IR/HR MLL-R Chemotherapy and Lestaurtinib) | 0.47 |
Number of Participants in the Dose Escalation Phase Who Reached Maximum Tolerated Dose (MTD) of Dasatinib With Lenalidomide and Dexamethasone
The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than 33% of participants during the escalation and expansion phase. Please refer to outcome 2 for the complete definition of DLT. If the MTD was not reached at the highest dose administered as defined by protocol, the highest dose (dasatinib 140 mg QD + lenalidomide 25 mg QD) administered was selected for the dose expansion phase of the study. (NCT00560391)
Timeframe: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
| Intervention | participants (Number) |
|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 0 |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 |
Number of Participants With Minimal Response
Response criteria was based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Minimal Response was achieved when there was 25% to 49% reduction of serum M-Protein, 50% to 89% reduction in 24 hour urinary M-protein which still exceeded 200 mg/24 hour. If the serum and urine M-protein were unmeasurable, 25% to 49% reduction in plasma cells was required. In addition, if present at baseline, a 25% to 49% reduction in the size of soft tissue plasmacytomas was also required. (NCT00560391)
Timeframe: Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
| Intervention | participants (Number) |
|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 0 |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 |
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): High Calcium, Low Calcium, Low Magnesium, and Low Phosphorus
Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Calcium (low): GR1: ULN - 11.5 mg/dL, GR2: >11.5 - 12.5 mg/dL, GR3: >12.5 - 13.5 mg/dL, GR4: >13.5 mg/dL. Magnesium (Low): GR1: NCT00560391)
Timeframe: Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])
| Intervention | participants (Number) |
|---|
| High Calcium; GR 0 at BL, GR 0PBL | High Calcium; GR 0 at BL, GR 1 to 2 PBL | High Calcium; GR 0 at BL, GR 3 to 4 PBL | High Calcium; GR 1 to 2 at BL, GR 0 PBL | High Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | High Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | Low Calcium; GR 0 at BL, GR 0 PBL | Low Calcium; GR 0 at BL, GR 1 to 2 PBL | Low Calcium; GR 0 at BL, GR 3 to 4 PBL | Low Calcium; GR 1 to 2 at BL, GR 0 PBL | Low Calcium; GR 1 to 2 at BL, GR 1 to 2 PBL | Low Calcium; GR 1 to 2 at BL, GR 3 to 4 PBL | Low Magnesium; GR 0 at BL, GR 0 PBL | Low Magnesium; GR 0 at BL, GR 1 to 2 PBL | Low Magnesium; GR 0 at BL, GR 3 to 4 PBL | Low Magnesium; GR 1 to 2 at BL, GR 0 PBL | Low Magnesium; GR 1 to 2 at BL, GR 1 to 2 PBL | Low Magnesium; GR 1 to 2 at BL, GR 3 to 4 PBL | Low Magnesium; GR Not reported at BL | Low Phosphorus; GR 0 at BL, GR 0 PBL | Low Phosphorus; GR 0 at BL, GR 1 to 2 PBL | Low Phosphorus; GR 0 at BL, GR 3 to 4 PBL | Low Phosphorus; GR 1 to 2 at BL, GR 0 PBL | Low Phosphorus; GR 1 to 2 at BL, GR 1 to 2 PBL | Low Phosphorus; GR 1 to 2 at BL, GR 3 to 4 PBL | Low Phosphorus; GR 3 to 4 at BL, GR 0 PBL | Low Phosphorus; GR 3 to 4 at BL, GR 1 to 2 PBL | Low Phosphorus; GR 3 to 4 at BL, GR 3 to 4 PBL |
|---|
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 3 | 0 | 0 | 0 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 1 |
,| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 4 | 0 | 0 | 0 | 2 | 0 | 2 | 4 | 0 | 0 | 0 | 0 | 2 | 3 | 0 | 0 | 1 | 0 | 0 | 3 | 2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 15 | 1 | 0 | 0 | 1 | 0 | 1 | 12 | 2 | 0 | 1 | 1 | 7 | 6 | 1 | 0 | 3 | 0 | 0 | 8 | 2 | 6 | 0 | 0 | 1 | 0 | 0 | 0 |
,| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 4 | 1 | 0 | 0 | 0 | 1 | 2 | 3 | 0 | 0 | 1 | 0 | 2 | 3 | 0 | 0 | 1 | 0 | 0 | 1 | 3 | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
,| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 2 | 0 | 0 | 0 | 1 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Number of Participants With Dose-limiting Toxicity (DLT)
DLTs: At least possibly drug-related AEs occurring during the first cycle of treatment and are:GR4 neutropenia >5 days/neutropenic fever;platelet count <10000mm^3 on >1 occasion;GR4 fatigue,or 2-point decline in ECOG performance status;>=GR3 nausea,diarrhea,and vomiting despite medical intervention;Any other clinically significant non-hematologic toxicity of >=GR3 considered not related to underlying MM;Any GR3/4 laboratory abnormality requiring hospitalization;dose interruption of either dasatinib and/or lenalidomide for >15 days due to any toxicity related to treatment with the combination. (NCT00560391)
Timeframe: From the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
| Intervention | participants (Number) |
|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 1 |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 1 |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 |
Number of Participants With Serum Chemistry Abnormalities (Worst On-study Grade vs Baseline): Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Total Bilirubin (TB), and Serum Creatinine (SC)
Grading as per NCI CTCAE Version 3.0 criteria. GR1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. Aspartate aminotransferase (AST) and alanine aminotransferase(ALT): GR1=>ULN-2.5*ULN (upper limit of normal); GR2=>2.5-5.0*ULN; GR3=>5.0-20.0*ULN; GR4:>20.0*ULN; TB:GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3-10*ULN, GR4=>10*ULN; SC: GR1=>ULN-1.5*ULN, GR2=>1.5-3.0*ULN, GR3=>3.0-6.0*ULN, GR4=>6.0*ULN. BL=Baseline; PBL=post baseline. (NCT00560391)
Timeframe: Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])
| Intervention | participants (Number) |
|---|
| AST; GR 0 at BL, GR 0 PBL | AST; GR 0 at BL, GR 1 to 2 PBL | AST; GR 0 at BL, GR 3 to 4 PBL | AST; GR 1 to 2 at BL, GR 0 PBL | AST; GR 1 to 2 at BL, GR 1 to 2 PBL | AST; GR 1 to 2 at BL, GR 3 to 4 PBL | High ALT; GR 0 at BL, GR 0 PBL | ALT; GR 0 at BL, GR 1 to 2 PBL | ALT; GR 0 at BL, GR 3 to 4 PBL | ALT; GR 1 to 2 at BL, GR 0 PBL | ALT; GR 1 to 2 at BL, GR 1 to 2 PBL | ALT; GR 1 to 2 at BL, GR 3 to 4 PBL | Total Bilirubin; GR 0 at BL, GR 0 PBL | Total Bilirubin; GR 0 at BL, GR 1 to 2 PBL | Total Bilirubin; GR 0 at BL, GR 3 to 4 PBL | SC; GR 0 at BL, GR 0 PBL | SC; GR 0 at BL, GR 1 to 2 PBL | SC; GR 0 at BL, GR 3 to 4 PBL | SC; GR 1 to 2 at BL, GR 0 PBL | SC; GR 1 to 2 at BL, GR 1 to 2 PBL | SC; GR 1 to 2 at BL, GR 3 to 4 PBL |
|---|
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 2 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 2 | 1 | 0 | 1 | 2 | 0 | 0 | 0 | 0 |
,| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 5 | 0 | 0 | 0 | 1 | 0 | 2 | 3 | 0 | 0 | 1 | 0 | 4 | 2 | 0 | 6 | 0 | 0 | 0 | 0 | 0 |
,| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 5 | 8 | 0 | 0 | 3 | 1 | 5 | 9 | 0 | 0 | 2 | 1 | 13 | 4 | 0 | 12 | 3 | 1 | 0 | 0 | 1 |
,| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 4 | 2 | 0 | 0 | 0 | 0 | 2 | 4 | 0 | 0 | 0 | 0 | 5 | 1 | 0 | 4 | 2 | 0 | 0 | 0 | 0 |
,| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | 2 | 0 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 0 | 1 | 1 | 0 | 1 | 1 | 0 | 0 | 1 | 0 |
Recommended Phase II Dose (RP2D) of the Combination (Dasatinib + Lenalidomide + Dexamethasone)
The RP2D was based on the MTD which was defined as the maximum combined dose producing dose limiting toxicity (DLT) in < 33% of participants treated at the individual dose levels in the combination. The MTD is considered the last dose level combination tested just below the maximum administered dose (MAD) level combination and for which DLTs were observed in less than or equal to 33% of participants during the escalation and expansion phase. If MTD was not reached Please refer to Outcome Measure 2 for the complete definition of DLT. (NCT00560391)
Timeframe: From the date of first dose to end of treatment (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
| Intervention | mg (Number) |
|---|
| RP2D of dasatinib in the combination | RP2D of lenalidomide in the combination | RP2D dexamethasone in the combination |
|---|
| All Treated Participants | 140 | 25 | 40 |
Number of Participants With Hematology Abnormalities (Worst On-study Grade vs Baseline): Leukopenia, Neutropenia, Thrombocytopenia, and Anemia
As per NCI CTCAE Version 3.0 criteria. Grade (GR)1=Mild; GR2=Moderate; GR3=Severe; GR4=Life-threatening or disabling. White blood cell (WBC):GR1=NCT00560391)
Timeframe: Baseline (pretreatment); Cycles 1 and 2 (within 24 hours of Days 1, 4, 8, 11, 15, 18, 21, and 25); beyond Cycle 2 (within 24 hours of Days 1 and 15,off treatment visit ) (median duration of dasatinib treatment=5.2 mo [range 0 to 33 mo])
| Intervention | participants (Number) |
|---|
| Leukopenia; GR 0 at BL, GR 0 PBL | Leukopenia; GR 0 at BL, GR 1 to 2 PBL | Leukopenia; GR 0 at BL, GR 3 to 4 PBL | Leukopenia; GR 1 to 2 at BL, GR 0 PBL | Leukopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | Leukopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | Neutropenia; GR 0 at BL, GR 0 PBL | Neutropenia; GR 0 at BL, GR 1 to 2 PBL | Neutropenia; GR 0 at BL, GR 3 to 4 PBL | Neutropenia; GR 1 to 2 at BL, GR 0 | Neutropenia; GR 1 to 2 at BL, GR 1 to 2 PBL | Neutropenia; GR 1 to 2 at BL, GR 3 to 4 PBL | Thrombocytopenia; GR 0 at BL, GR 0 PBL | Thrombocytopenia; GR 0 at BL, GR 1 to 2 PBL | Thrombocytopenia; GR 0 at BL, GR 3 to 4 PBL | Thrombocytopenia; GR 1 to 2 at BL, GR 0 PBL | Thrombocytopenia; GR 1 to 2 at BL, GR 1 to 2 PBL | Thrombocytopenia; GR 1 to 2 at BL, GR 3 to 4 PBL | Anemia; GR 0 at BL, GR 0 PBL | Anemia; GR 0 at BL, GR 1 to 2 PBL | Anemia; GR 0 at BL, GR 3 to 4 PBL | Anemia; GR 1 to 2 at BL, GR 0 PBL | Anemia; GR 1 to 2 at BL, GR 1 to 2 PBL | Anemia; GR 1 to 2 at BL, GR 3 to 4 PBL | Anemia; GR 3 to 4 at BL, GR 0 PBL | Anemia; GR 3 to 4 at BL, GR 1 to 2 PBL | Anemia; GR 3 to 4 at BL, GR 3 to 4 PBL | Anemia; GR Not reported at BL |
|---|
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | 3 | 0 | 0 | 0 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 | 2 | 0 | 0 | 1 | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
,| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 1 | 2 | 0 | 0 | 0 | 3 | 0 | 3 | 0 | 0 | 0 | 3 | 1 | 3 | 0 | 0 | 1 | 1 | 0 | 3 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 |
,| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 2 | 6 | 3 | 0 | 1 | 5 | 1 | 3 | 8 | 0 | 1 | 4 | 2 | 5 | 2 | 0 | 3 | 5 | 0 | 6 | 1 | 0 | 5 | 5 | 0 | 0 | 0 | 0 |
,| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 0 | 1 | 2 | 0 | 0 | 3 | 0 | 2 | 3 | 0 | 0 | 1 | 0 | 3 | 0 | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 1 | 0 |
,| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 2 | 1 | 0 | 0 | 0 | 0 | 1 | 1 | 1 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 1 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
Number of Participants With Complete Response and Very Good Partial Response
Response criteria were based on The International Uniform Response Criteria for Multiple Myeloma (with a slight modification). Complete response was achieved when there was negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and ≤ 5% plasma cells in bone marrow. Very good partial response was achieved when serum and urine M-component was detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-component plus urine M-component < 100 mg per 24 hour. (NCT00560391)
Timeframe: Baseline, At the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
| Intervention | participants (Number) |
|---|
| Complete response | Very good partial response | No response | Not reported | Response Undetermined |
|---|
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | 0 | 1 | 0 | 0 |
,| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 | 1 | 1 | 0 | 0 |
,| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 0 | 3 | 11 | 0 | 0 |
,| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 0 | 0 | 4 | 1 | 0 |
,| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | 0 | 2 | 0 | 0 |
Number of Participants Who Died, Serious Adverse Events (SAEs), Adverse Events (AEs) and AEs Leading to Study Drug Discontinuation
AE: New untoward medical occurrence or worsening of a preexisting medical condition that does not have causal relationship with this treatment. SAE: Untoward medical event that at any dose: results in death, persistent or significant disability/incapacity, drug dependency/abuse; life-threatening, an important medical event, a congenital anomaly/birth defect; requires inpatient hospitalization/prolongs existing hospitalization. Grade 1= Mild; Grade 2= Moderate; Grade 3= Severe; Grade 4 = Life-threatening or disabling. (NCT00560391)
Timeframe: Baseline (pretreatment), from the date of first dose until at least 30 days after the last dose of study drug (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
| Intervention | participants (Number) |
|---|
| All deaths | Deaths within 30 days of last dose | All SAEs | Drug-related SAEs | AEs leading to discontinuation | Drug-related AEs leading to discontinuation | All AEs | Drug-related AEs |
|---|
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 0 | 0 | 2 | 1 | 1 | 0 | 3 | 3 |
,| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 1 | 0 | 5 | 1 | 1 | 0 | 6 | 6 |
,| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 3 | 2 | 9 | 4 | 8 | 7 | 17 | 17 |
,| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 3 | 1 | 3 | 1 | 2 | 2 | 6 | 6 |
,| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 2 | 1 | 2 | 1 | 1 | 0 | 3 | 3 |
Number of Participants With Partial Response
Partial response was achieved when there was ≥50% reduction of serum M-protein (Mpr)and reduction in 24 hour urinary Mpr by ≥90% or to <200 mg/24 hr. If the serum and urine Mpr were unmeasurable, a ≥50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the Mpr criteria. If serum, urine Mpr, and serum FLC assay were unmeasurable, ≥50% reduction in plasma cells was required in place of Mpr, provided baseline bone marrow plasma cell percentage was ≥30%; a ≥50% reduction in the size of soft tissue plasmacytomas was also required. (NCT00560391)
Timeframe: Baseline, at the end of the treatment period (median duration of dasatinib treatment=5.2 months [range 0 to 33 months]).
| Intervention | participants (Number) |
|---|
| Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg | 1 |
| Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 1 |
| Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg | 2 |
| Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 4 |
| Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg | 3 |
Area Under the Plasma Concentration-time Curve (AUC) 0-72 Hours
(NCT00608907)
Timeframe: Cycle 3 day 14 (72 hours post last dose)
| Intervention | ng*h/mL (Mean) |
|---|
| VELCADE + Rifampicin | 123 |
| VELCADE + Dexamethasone | 170 |
| VELCADE | 215 |
Proportion of Participants With Best Overall Tumor Response (Response Rate)
Response defined per Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Complete Response (CR)=disappearance of all target lesions; Partial Response (PR)=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria. Best Overall Tumor Response is complete response plus partial response. (NCT00609518)
Timeframe: Baseline until disease progression, new therapy initiated, or death from any cause, up to 12 months after enrollment.
| Intervention | proportion of patients (Mean) |
|---|
| Standard Vitamin and Steroid Schedule + Pemetrexed | 0.118 |
| Simplified Vitamin and Steroid Schedule + Pemetrexed | 0.064 |
Overall Survival
Overall survival is the duration from randomization to death. For patients who are alive, overall survival is censored at the date of last contact. (NCT00609518)
Timeframe: Randomization (≤4 weeks from baseline visit) to 12 months after randomization
| Intervention | months (Median) |
|---|
| Standard Vitamin and Steroid Schedule + Pemetrexed | 8.2 |
| Simplified Vitamin and Steroid Schedule + Pemetrexed | 9.2 |
Progression-free Survival (PFS)
Defined as the time from date of first dose to the first observation of disease progression, or death due to any cause. For patients who are alive and have not progressed, PFS is censored at the date of last radiological assessment. (NCT00609518)
Timeframe: Randomization (≤4 weeks from baseline visit) to 12 months after randomization
| Intervention | months (Median) |
|---|
| Standard Vitamin and Steroid Schedule + Pemetrexed | 3.7 |
| Simplified Vitamin and Steroid Schedule + Pemetrexed | 3.8 |
No Vomiting Overall (in the 120 Hours Following Initiation of Cisplatin)
The number of patients who reported No Vomiting in the 120 hours following initiation of cisplatin chemotherapy. (NCT00619359)
Timeframe: Overall (the 120 hours following initiation of cisplatin chemotherapy)
| Intervention | Participants (Number) |
|---|
| Fosaprepitant | 806 |
| Aprepitant | 844 |
A Complete Response (no Vomiting and no Use of Rescue Therapy) Overall (in the 120 Hours Following Initiation of Cisplatin).
The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 120 hours following initiation of cisplatin chemotherapy. (NCT00619359)
Timeframe: Overall (in the 120 hours following initiation of cisplatin chemotherapy).
| Intervention | Participants (Number) |
|---|
| Fosaprepitant | 795 |
| Aprepitant | 820 |
A Complete Response (no Vomiting and no Use of Rescue Therapy) in the Delayed Phase (25 to 120 Hours Following Initiation of Cisplatin).
The number of patients who reported No Vomiting and No Use of Rescue Therapy in the 25 to 120 hours following initiation of cisplatin chemotherapy. (NCT00619359)
Timeframe: Delayed phase (25 to 120 hours following initiation of cisplatin).
| Intervention | Participants (Number) |
|---|
| Fosaprepitant | 822 |
| Aprepitant | 841 |
Number of Patients Who Are Progression-free and Alive at 6 Months
"Disease stability was assessed by evaluating the proportion of participants who are progression free (and alive) at 6 months.~Progression was defined as any one or more of the following:~An increase of 25% from lowest confirmed response:~Serum M-component (absolute increase >=1.0 g/dL)~Urine M-component (absolute increase >=200 mg/24 hours)~An increase of 50% above the lowest remission value in bone marrow plasmacytosis (absolute increase 25% bone marrow plasma cells)~Development of new bone lesions or soft tissue plasmacytomas." (NCT00635154)
Timeframe: at 6 months
| Intervention | participants (Number) |
|---|
| Anakinra With/Without Dexamethasone | 49 |
Progression Free Survival (PFS) in Patients Treated With Anakinra Alone or in Combination With Dexamethasone
"PFS was defined as the time from registration to progression or death due to any cause.~Progression is defined the same as outcome measure #3." (NCT00635154)
Timeframe: Time from registration to progression or death (up to 5 years)
| Intervention | months (Median) |
|---|
| Anakinra With/Without Dexamethasone | 37.5 |
Patients With Confirmed Response (Complete Response, Very Good Partial Response, Partial Response, or Minimal Response) on 2 Consecutive Months During the First 6 Months of Treatment With Anakinra Alone
"Response Definitions:~Complete Response(CR):disappearance of M-Protein from serum & urine and immunofixation, <5% bone marrow(BM) plasma cells & disappearance of soft tissue plasmacytomas(STP);~Very Good Partial Response(VGPR):>=90% decrease in serum M-Protein, Urine M-protein <100 mg/24 hours, <=5% BM plasma cells, disappearance of STP;~Partial response(PR):>=50% reduction in serum M-protein, >=90% decrease in Urine M-protein or <200 mg/24 hours & >=50% decrease in STP;~Minor response(MR):25-49% decrease in serum M-protein, 50-89% decrease in urine M-protein & 25-49% decrease in STP" (NCT00635154)
Timeframe: 6 months
| Intervention | participants (Number) |
|---|
| Anakinra Without Dexamethasone | 1 |
Number of Patients With Severe Non-hematological Adverse Events in Patients Receiving Anakinra Alone or in Combination With Dexamethasone.
Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2. (NCT00635154)
Timeframe: Duration of treatment (up to 5 years)
| Intervention | participants (Number) |
|---|
| Anakinra With/Without Dexamethasone | 7 |
Number of Patients With Severe Non-hematological Adverse Events in Participants Receiving Anakinra in Combination With Dexamethasone
Severe non-hematologic adverse events were defined as adverse events grade 4 (life threatening or disabling) or grade 5 (death), regardless of attribution to study drug. Adverse events were graded according to the National Cancer Institute Common Toxicity Criteria (CTC) version 2. (NCT00635154)
Timeframe: every cycle during treatment (up to 5 years)
| Intervention | participants (Number) |
|---|
| Anakinra With Dexamethasone | 4 |
Number of Patients With Response to Treatment With Dexamethasone and Anakinra
"Response on 2 consecutive months during active treatment with anakinra alone or in combination with dexamethasone.~Response criteria is the same as in Primary Outcome Measure." (NCT00635154)
Timeframe: During Active treatment (up to 5 years)
| Intervention | participants (Number) |
|---|
| Anakinra With Dexamethasone | 14 |
Duration of Response
Duration of response is defined for all evaluable participants (receiving Anakinra alone or in combination with Dexamethasone) who have achieved an objective response as the date at which the participants status was first noted to be MR or better to the date progression is documented or the date of last follow-up. (NCT00635154)
Timeframe: From first documentation of response to progression or last follow-up (up to 5 years)
| Intervention | months (Median) |
|---|
| Anakinra With/Without Dexamethasone | 41.9 |
Overall Survival
Unstratified median overall survival in months. (NCT00644228)
Timeframe: Up to 6 years
| Intervention | Months (Median) |
|---|
| Arm I (Dexamethasone and Lenalidomide) | 64 |
| Arm II (Dexamethasone, Lenalidomide, Bortezomib) | 75 |
Response Rates ()
The response rate was calculated as the number of patients with documented confirmed partial response (PR) or better, which includes confirmed/unconfirmed stringent complete response (sCR), confirmed/unconfirmed complete response (CR), confirmed/unconfirmed very good partial response (VGPR), or confirmed partial response (PR), as best response divided by the total number of evaluable patients, in each arm. Patients with measurable disease, as defined in the protocol, are evaluable. Response rates were compared between the two treatment arms using a stratified Cochran-Mantel-Haenszel test. Response designations were based on the International Uniform Response Criteria for Multiple Myeloma. Due to the complexity of these criteria, the details of these criteria have been omitted. (NCT00644228)
Timeframe: Up to 6 years
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Dexamethasone and Lenalidomide) | 153 |
| Arm II (Dexamethasone, Lenalidomide, Bortezomib) | 176 |
Progression-free Survival
Unstratified median progression-free survival in months. (NCT00644228)
Timeframe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 6 years
| Intervention | Months (Median) |
|---|
| Arm I (Dexamethasone and Lenalidomide) | 30 |
| Arm II (Dexamethasone, Lenalidomide, Bortezomib) | 43 |
Overall Survival, Censoring Participants Who Receive a Stem Cell Transplant at the Time of the Transplant
Overall survival (OS) was defined as the time interval from randomization to death from any cause. Any participants who received a stem cell transplant were censored at the time of transplant. The median OS with 95% CI was estimated using the Kaplan-Meier method. (NCT00651261)
Timeframe: Duration of study (Up to 10 years)
| Intervention | months (Median) |
|---|
| Induction and Consolidation Chemotherapy Plus Midostaurin | NA |
| Induction and Consolidation Chemotherapy Plus Placebo | NA |
Overall Survival (OS)
Overall survival (OS) was defined as the time interval from randomization to death from any cause. The median OS with 95% CI was estimated using the Kaplan-Meier method. (NCT00651261)
Timeframe: Duration of study (Up to 10 years)
| Intervention | months (Median) |
|---|
| Induction and Consolidation Chemotherapy Plus Midostaurin | 74.7 |
| Induction and Consolidation Chemotherapy Plus Placebo | 25.6 |
Event- Free Survival
"Event free survival (EFS) was defined as the time from randomization until the earliest qualifying event, including: failure to obtain a CR on or before 60 days of initiation of protocol therapy; relapse; or death from any cause. Patients alive and event free at the time of analysis were censored on the date of last clinical assessment. The median EFS with 95% CI was estimated using the Kaplan-Meier method.~Due to a higher than expected transplant rate, EFS was promoted to be a key secondary endpoint." (NCT00651261)
Timeframe: Duration of study (Up to 10 years)
| Intervention | months (Median) |
|---|
| Induction and Consolidation Chemotherapy Plus Midostaurin | 8.2 |
| Induction and Consolidation Chemotherapy Plus Placebo | 3.0 |
Disease-free Survival (DFS)
Disease free survival (DFS) is defined as the time from documentation of first CR at any time to the first of relapse or death from any cause in participants who achieved a CR. (NCT00651261)
Timeframe: Duration of study (Up to 10 years)
| Intervention | months (Median) |
|---|
| Induction and Consolidation Chemotherapy Plus Midostaurin | 26.7 |
| Induction and Consolidation Chemotherapy Plus Placebo | 15.5 |
Complete Response Rate
Percentage of participants who achieved a complete response (CR). A CR was defined as normalization of blood counts and a marrow showing less than 5% blasts occurring on or before day 60. (NCT00651261)
Timeframe: Induction therapy (up to 60 days)
| Intervention | percentage of participants (Number) |
|---|
| Induction and Consolidation Chemotherapy Plus Midostaurin | 59 |
| Induction and Consolidation Chemotherapy Plus Placebo | 54 |
Number of Participants With Discontinuation of Treatment Due to Adverse Events, Deaths or Serious Adverse Events During the Study
Additional safety information can be found in the Adverse Event section. (NCT00663169)
Timeframe: 4 months
| Intervention | Participants (Number) |
|---|
| Discontinuation from treatment | Death | Serious Adverse Event |
|---|
| Canakinumab | 0 | 0 | 0 |
,| Dexamethasone | 0 | 0 | 1 |
ACZ885 (Canakinumab) Pharmacokinetics (PK) Serum Concentration During the Treatment Period
Blood was collected for ACZ885 (canakinumab) levels at baseline and Days 0.25, 1, 3, 6, 20, 34, 55 and 119. Serum was analyzed by means of a competitive Enzyme linked immunosorbant assay (ELISA). (NCT00663169)
Timeframe: Baseline, Days 0.25, 1, 3, 6, 20, 34, 55 and 119
| Intervention | μg/mL (Mean) |
|---|
| Baseline | Day 0.25 | Day 1 (n=2) | Day 3 (n=1) | Day 6 | Day 20 | Day 34 | Day 55 | Day 119 |
|---|
| Canakinumab | 0.0 | 221.5 | 276.5 | 92.3 | 136.6 | 72.37 | 52.87 | 31.67 | 7.643 |
Percentage of Participants With Improvement in Gout at 72 Hours Post-dose Using a Likert Scale
"72 hours following treatment, patients were asked the question: How would you rate the improvement in your gout since receiving the study medication? Patients rated their improvement on the Likert 5-point scale: 1=Excellent, 2=Good, 3=Acceptable,4=Slight and 5=Poor. Improvement was assessed by determining patients who scored a good or excellent response." (NCT00663169)
Timeframe: 72 hours
| Intervention | Percentage of participants (Number) |
|---|
| Canakinumab | 100 |
| Dexamethasone | 100 |
Number of Patients Who Took Rescue Medication
Patients who did not improve by 72 hours post-dose (i.e. patients who show a pain Visual Analog (VAS) decrease of less than 50 % from baseline (Day 1, pre-dose) would have been treated with rescue medication of methylprednisolone 80 mg intravenous or intramuscular once at the discretion of the clinical investigator. (NCT00663169)
Timeframe: 4 months
| Intervention | Participants (Number) |
|---|
| Canakinumab | 0 |
| Dexamethasone | 0 |
Change in Serum Amyloid A Protein (SAA) From Baseline at Month 4
Blood was collected at Baseline and Month 4 for SAA to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement. (NCT00663169)
Timeframe: Baseline, Month 4
| Intervention | mg/L (Mean) |
|---|
| Canakinumab | -579.980 |
| Dexamethasone | -260.327 |
Change in C-reactive Protein (CRP) From Baseline at Month 4
Blood was collected at Baseline and Month 4 for CRP to identify the presence of inflammation, to determine its severity, and to monitor response to treatment. A negative change from baseline indicates improvement. (NCT00663169)
Timeframe: Baseline, Month 4
| Intervention | mg/L (Mean) |
|---|
| Canakinumab | -22.23 |
| Dexamethasone | -30.30 |
Change From Baseline in Pain Using a Visual Analog Scale at Month 4
Patients rated their pain on a 100 millimeter (mm) visual analog scale, ranging from no pain (0) to unbearable pain (100). A negative change from baseline indicates improvement. (NCT00663169)
Timeframe: Baseline, Month 4
| Intervention | Score on a scale (Mean) |
|---|
| Canakinumab | -62.0 |
| Dexamethasone | -65.7 |
Percentage of Participants With Event-free Survival (EFS)
Percentage of participants who were event free. Event Free Probability defined as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignant neoplasm, remission death) or date of last contact for subjects who are event-free. (NCT00671034)
Timeframe: 5 Years
| Intervention | Percentage of participants (Number) |
|---|
| Arm I (Calaspargase Pegol 2100) | 72.35 |
| Arm II (Calaspargase Pegol 2500) | 80.8 |
| Arm III (Pegaspargase 2500) | 79.34 |
Percentage of Participants With Complete Remission at the End of Induction
Complete Remission (CR) rate; where CR is defined as M1 marrow (< 5% lymphoblasts in the bone marrow) (NCT00671034)
Timeframe: End of induction (Day 29)
| Intervention | Percentage of participants (Number) |
|---|
| Arm I (Calaspargase Pegol 2100) | 92.4 |
| Arm II (Calaspargase Pegol 2500) | 97.6 |
| Arm III (Pegaspargase 2500) | 94.1 |
Toxicities During Post Induction Intensification Therapy (All Grades)
The calculation of AE incidence will be based on the number of patients per AE category. For each patient who has multiple AEs classified to the same category, that patient will be tabulated under the worst toxicity grade for that AE category. The incidence of AEs will be tabulated by treatment arm and by organ class. Special attention will be paid to hypersensitivity, pancreatitis, coagulopathy, infection, neurologic dysfunction and thromboembolic events. (NCT00671034)
Timeframe: Up to 5 years
| Intervention | Percentage of participants (Number) |
|---|
| Alergic Reaction - Consolidation | Alergic Reaction - Delayed Intensification I | Alergic Reaction - Interim Maintenance I | CNS - Consolidation | CNS - Delayed Intensification I | CNS - Interim Maintenance I | Hyperbilirubinemia - Consolidation | Hyperbilirubinemia - Delayed Intensification I | Hyperbilirubinemia - Interim Maintenance I | Hyperglycemia - Consolidation | Hyperglycemia - Delayed Intensification I | Hyperglycemia - Interim Maintenance I | Hyperlipidemia - Consolidation | Hyperlipidemia - Delayed Intensification I | Hyperlipidemia - Interim Maintenance I | % patients w/INR increase - Consolidation | % pts w/INR increase - Delayed Intensification I | % patients w/INR increase - Interim Maintenance I | Pancreatitis - Consolidation | Pancreatitis -Delayed Intensification I | Pancreatitis - Interim Maintenance I | % pts w/prolongation of APT time - Consolidation | % pts w/prolongation APT time -Delayed Intension I | %pts w/prolongation APT time-Interim maintenance I | Thrombosis - Consolidation | Thrombosis - Delayed Intensification I | Thrombosis - Interim Maintenance I |
|---|
| Arm I (Calaspargase Pegol 2100) | 20.4 | 4.4 | 0.0 | 0.0 | 0.0 | 0.0 | 53.1 | 28.9 | 41.3 | 44.9 | 44.4 | 34.8 | 2.0 | 2.2 | 2.2 | 6.1 | 6.7 | 2.2 | 10.2 | 2.2 | 2.2 | 8.2 | 8.9 | 6.5 | 0.0 | 2.2 | 0.0 |
,| Arm II (Calaspargase Pegol 2500) | 27.3 | 0.0 | 0.0 | 0.0 | 3.8 | 0.0 | 45.5 | 38.5 | 27.6 | 42.4 | 61.5 | 44.8 | 3.0 | 0.0 | 3.4 | 3.0 | 3.8 | 0.0 | 6.1 | 7.7 | 3.4 | 9.1 | 26.9 | 6.9 | 0.0 | 0.0 | 0.0 |
,| Arm III (Pegaspargase 2500) | 23.3 | 0.0 | 2.1 | 0.0 | 2.6 | 0.0 | 30.2 | 10.5 | 33.3 | 46.5 | 36.8 | 33.3 | 7.0 | 0.0 | 2.6 | 7.0 | 0.0 | 2.6 | 7.0 | 0.0 | 2.6 | 7.0 | 18.4 | 7.7 | 2.3 | 0.0 | 0.0 |
Plasma and CSF Concentrations of Asparagine in ug/ml
The plasma and CSF concentrations of asparagine in ug/ml after administration of EZN-2285 compared to Oncaspar. (NCT00671034)
Timeframe: 25 Days Post-dose (Day 29)
| Intervention | ug/mL (Mean) |
|---|
| CSF asparagine concentration (ug/mL) | Plasma asparagine concentration (ug/mL) |
|---|
| Arm I (Calaspargase Pegol 2100) | 0.2 | 0.2 |
,| Arm II (Calaspargase Pegol 2500) | 0.19 | 0.25 |
,| Arm III (Pegaspargase 2500) | 0.26 | 0.83 |
Immunogenicity
Number of Patients with Positive Immunogenicity tests (NCT00671034)
Timeframe: 25 Days Post-dose (Day 29)
| Intervention | Participants (Count of Participants) |
|---|
| Arm I (Calaspargase Pegol 2100) | 2 |
| Arm II (Calaspargase Pegol 2500) | 2 |
| Arm III (Pegaspargase 2500) | 4 |
Percentage of Participants With Minimal Residual Disease (MRD)<0.01% at the End of Induction
Percentage of participants with Negative MRD (MRD<0.01%). (NCT00671034)
Timeframe: End of induction (Day 29)
| Intervention | Percentage of participants (Number) |
|---|
| Arm I (Calaspargase Pegol 2100) | 65.2 |
| Arm II (Calaspargase Pegol 2500) | 81 |
| Arm III (Pegaspargase 2500) | 72.5 |
Asparaginase Level
The proportion of patients with an asparaginase level of at least 0.1 IU/mL and the proportion with at least 0.4 IU/mL on Days 4, 15, 22 and 29 of Induction compared to Oncaspar (NCT00671034)
Timeframe: Days 4, 15, 22 and 29 of Induction
| Intervention | percentage of patients (Number) |
|---|
| Level at least 0.1 IU/mL day 4 | Level at least 0.1 IU/mL day 15 | Level at least 0.1 IU/mL day 22 | Level at least 0.1 IU/mL day 29 | Level at least 0.4 IU/mL day 4 | Level at least 0.4 IU/mL day 15 | Level at least 0.4 IU/mL day 22 | Level at least 0.4 IU/mL day 29 |
|---|
| Arm I (Calaspargase Pegol 2100) | 0 | 98.4 | 98.2 | 94.9 | 0 | 75.8 | 37.5 | 13.6 |
,| Arm II (Calaspargase Pegol 2500) | 0 | 100 | 100 | 95.0 | 0 | 95.0 | 62.5 | 27.5 |
,| Arm III (Pegaspargase 2500) | 0 | 100 | 95.1 | 28.6 | 0 | 93.0 | 14.6 | 0 |
Pharmacodynamics (PD)
Plasma Asparaginase Concentration During consolidation and induction. (NCT00671034)
Timeframe: Day 29 of consolidation and induction
| Intervention | mIU/mL (Median) |
|---|
| Plasma Asparaginase Concentration- Consolidation | Plasma Asparaginase Concentration- Induction |
|---|
| Arm I (Calaspargase Pegol 2100) | 575.9 | 271.6 |
,| Arm II (Calaspargase Pegol 2500) | 617.2 | 339.6 |
,| Arm III (Pegaspargase 2500) | 562.1 | 72.8 |
Pharmacokinetics (PK) (Half-life of SC-PEG E. Coli L-asparaginase (EZN-2285) Compared to Pegaspargase During Induction and Consolidation Therapy)
Mean half-life of plasma asparaginase during consolidation and Induction; half-life is defined as the time taken for drug concentration to decrease by half. (NCT00671034)
Timeframe: Post Day 29 of Induction and Post Day 22 of Consolidation
| Intervention | hours (Mean) |
|---|
| Asparaginase half-life during Consolidation | Asparaginase half-life during Induction |
|---|
| Arm I (Calaspargase Pegol 2100) | 415.8 | 305.1 |
,| Arm II ( Calaspargase Pegol 2500) | 355.9 | 321.5 |
,| Arm III (Pegaspargase 2500) | 117.2 | 126.9 |
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Disease Symptoms Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score indicates more severe disease symptom(s). (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | -4.1 | -10.0 | -9.9 | -8.7 | -6.2 | -4.5 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.0 | -9.1 | -8.8 | -7.8 | -8.7 | -3.5 |
,| Melphalan + Prednisone + Thalidomide (MPT) | -4.4 | -7.0 | -7.9 | -6.5 | -7.9 | -3.7 |
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Future Perspective Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the future perspective scale, a higher score indicates a better perspective of the future. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | 3.9 | 9.2 | 12.3 | 12.1 | 11.7 | 8.8 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 4.7 | 8.5 | 9.8 | 10.8 | 12.7 | 5.8 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 3.3 | 6.3 | 8.0 | 10.0 | 9.5 | 3.2 |
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Side Effects Treatment Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; a higher score represents a more severe overall side effect of treatment. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | 4.0 | 1.2 | -0.4 | 1.2 | 2.3 | -1.0 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.5 | 1.0 | 1.7 | 1.9 | 2.2 | 0.6 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 5.6 | 3.5 | 2.9 | 4.7 | 4.3 | 3.8 |
Change From Baseline in the European Quality of Life-5 Dimensions (EQ-5D) Health Utility Index Score
EQ-5D is a self-administered questionnaire that assesses health-related quality of life. The EQ-5D descriptive health profile comprises five dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Each dimension has 3 levels of response: No problem (1), some problems (2), and extreme problems (3). A unique EQ-5D health state is defined by combining one level from each of the five dimensions into a single utility index score. EQ-5D index values range from -0.59 to 1.00 where higher EQ-5D scores represent better health status. A positive change from baseline score indicates improvement in health status and better health state. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | -0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 0.0 | 0.1 | 0.1 | 0.1 | 0.1 | 0.0 |
Shift From Baseline to Most Extreme Postbaseline Value in Absolute Neutrophil Count During the Active Treatment Phase
Neutrophil counts was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | participants (Number) |
|---|
| Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade 1 Baseline to Normal postbaseline | Grade1 Baseline to Grade 1 postbaseline | Grade 1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade3 Baseline to Grade 4 postbaseline | Grade 4 Baseline to Normal postbaseline Grade | Grade 4 Baseline to Grade 1 postbaseline Grade | Grade 4 Baseline to Grade 2 postbaseline | Grade 4 Baseline Grade to Grade 3 postbaseline | Grade 4 Baseline to Grade 4 postbaseline |
|---|
| Lenalidomide and Dexamethasone Rd18 | 133 | 85 | 109 | 71 | 30 | 6 | 11 | 15 | 30 | 4 | 0 | 1 | 11 | 18 | 5 | 0 | 0 | 1 | 2 | 2 | 0 | 0 | 0 | 0 | 0 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 103 | 96 | 121 | 70 | 21 | 7 | 8 | 17 | 25 | 9 | 1 | 1 | 14 | 18 | 9 | 0 | 0 | 2 | 2 | 0 | 0 | 1 | 0 | 0 | 0 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 37 | 79 | 128 | 141 | 45 | 2 | 2 | 11 | 20 | 21 | 0 | 1 | 7 | 21 | 10 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
Shift From Baseline to Most Extreme Postbaseline Value in Creatinine Clearance (CrCl) During the Active Treatment Phase
Renal function was assessed for participants from baseline to the most extreme value in creatinine clearance calculated using the Cockcroft-Gault estimation. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | participants (Number) |
|---|
| CrCl< 30 mL/min to CrCl< 30 mL/min | CrCl < 30 mL/min to CrCl ≥ 30 but < 50 mL/min | CrCl < 30 mL/min to CrCl ≥ 50 but < 80 mL/min | CrCl< 30 mL/min to ≥ 80 mL/min | CrCl≥ 30 but < 50 mL/min to < 30 mL/min | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 30 but < 50 mL | CrCl ≥ 30 but < 50 mL/min to CrCl ≥ 50 but < 80 mL | CrCl ≥ 30 but < 50 mL/min to ≥ 80 mL/min | CrCl ≥ 50 but < 80 mL to CrCl< 30 mL/min | CrCl ≥ 50 but < 80 mL to CrCl ≥ 30 but < 50 mL/min | CrCl ≥ 50 but < 80 mL to CrCl ≥ 50 but < 80 mL/min | CrCl ≥ 50 but < 80 mL to ≥ 80 mL/min | CrCl ≥ 80 mL/min to CrCl< 30 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 30 but < 50 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 50 but < 80 mL/min | CrCl ≥ 80 mL/min to CrCl ≥ 80 mL/min |
|---|
| Lenalidomide and Dexamethasone Rd18 | 17 | 14 | 8 | 2 | 2 | 41 | 55 | 12 | 0 | 1 | 130 | 99 | 1 | 0 | 10 | 114 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 15 | 18 | 7 | 2 | 1 | 37 | 67 | 9 | 0 | 4 | 112 | 107 | 0 | 0 | 6 | 109 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 19 | 19 | 5 | 0 | 0 | 41 | 65 | 2 | 0 | 4 | 102 | 97 | 0 | 0 | 9 | 121 |
Shift From Baseline to Most Extreme Postbaseline Value in Hemoglobin During the Active Treatment Phase
Hemoglobin was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | participants (Number) |
|---|
| Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade 1 Baseline to Normal postbaseline | Grade 1 Baseline to Grade 1 postbaseline | Grade1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade 3 Baseline to Grade 4 postbaseline | Grade 4 Baseline to Normal postbaseline | Grade 4 Baseline to Grade 1 postbaseline | Grade 4 Baseline to Grade 2 postbaseline | Grade 4 Baseline to Grade 3 postbaseline | Grade 4 Baseline to Grade 4 postbaseline |
|---|
| Lenalidomide and Dexamethasone Rd18 | 10 | 30 | 8 | 1 | 0 | 0 | 126 | 123 | 17 | 5 | 0 | 12 | 135 | 41 | 9 | 0 | 1 | 4 | 8 | 3 | 0 | 0 | 0 | 1 | 1 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 6 | 39 | 8 | 0 | 0 | 0 | 106 | 128 | 25 | 2 | 0 | 8 | 125 | 48 | 4 | 0 | 0 | 12 | 10 | 5 | 0 | 0 | 0 | 0 | 1 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 9 | 25 | 4 | 1 | 0 | 0 | 110 | 123 | 20 | 4 | 0 | 14 | 133 | 47 | 11 | 0 | 0 | 10 | 10 | 2 | 0 | 0 | 1 | 0 | 2 |
Percentage of Participants With a Myeloma Response by Favorable Hyperdiploidy Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | percentage of participants (Number) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.4 |
| Lenalidomide and Dexamethasone Rd18 | 81.6 |
| Melphalan + Prednisone + Thalidomide (MPT) | 70.6 |
Kaplan Meier Estimates for Time to Second-line Anti-myeloma Treatment (AMT)
Time to second-line anti-myeloma therapy was defined as time from randomization to the start of another non-protocol anti-myeloma therapy. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 23.0 months
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 39.1 |
| Lenalidomide and Dexamethasone Rd18 | 28.5 |
| Melphalan + Prednisone + Thalidomide (MPT) | 26.7 |
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by an Investigator Assessment at Time of Final Analysis
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median follow-up for responders was 19.9 months
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 31.5 |
| Lenalidomide and Dexamethasone Rd18 | 21.5 |
| Melphalan + Prednisone + Thalidomide (MPT) | 22.1 |
Kaplan Meier Estimates of Duration of Myeloma Response as Determined by the IRAC
Duration of response was defined as the duration from the time when the response criteria were first met for CR or VGPR or PR based on IMWG criteria until the first date the response criteria were met for progressive disease or until the participant died from any cause, whichever occurred first. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median follow-up for responders was 20.1 months
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 35.0 |
| Lenalidomide and Dexamethasone Rd18 | 22.1 |
| Melphalan + Prednisone + Thalidomide (MPT) | 22.3 |
Kaplan Meier Estimates of Overall Survival at the Time of Final Analysis (OS)
Overall survival was defined as the time between randomization and death. Participants, who died, regardless of the cause of death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the participant was known to be alive. (NCT00689936)
Timeframe: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 48.3 months
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 59.1 |
| Lenalidomide and Dexamethasone Rd18 | 62.3 |
| Melphalan + Prednisone + Thalidomide (MPT) | 49.1 |
Kaplan Meier Estimates of Time to Second Line Therapy AMT at the Time of Final Analysis
Time to second-line anti-myeloma therapy is defined as time from randomization to the start of another non-protocol anti-myeloma therapy. Those who do not receive another anti-myeloma therapy were censored at the last assessment or follow-up visit known to have received no new therapy. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of date 21 January 2016; median follow-up for all participants was 23.0 months
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 36.7 |
| Lenalidomide and Dexamethasone Rd18 | 28.5 |
| Melphalan + Prednisone + Thalidomide (MPT) | 26.7 |
Kaplan Meier Estimates of Time to Treatment Failure (TTF)
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by IRAC based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. (NCT00689936)
Timeframe: From date of randomization until the data cut-off of 24 May 2013; median follow-up for all participants was 16.1 months.
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 16.9 |
| Lenalidomide and Dexamethasone Rd18 | 17.2 |
| Melphalan + Prednisone + Thalidomide (MPT) | 14.1 |
Kaplan Meier Estimates of Time to Treatment Failure (TTF) at the Time of Final Analysis
TTF is defined as the time between the randomization and discontinuation of study treatment for any reason, including disease progression (determined by the investigators assessment based on the IMWG response criteria), treatment toxicity, start of another anti-myeloma therapy (AMT) or death. (NCT00689936)
Timeframe: From date of randomization until the data cut-off date of 21 January 2016; median follow up for all participants was 16.1 months.
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 16.9 |
| Lenalidomide and Dexamethasone Rd18 | 17.2 |
| Melphalan + Prednisone + Thalidomide (MPT) | 14.1 |
Kaplan-Meier Estimates of PFS Based on the Response Assessment by the Investigator At the Time of Final Analysis
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). (NCT00689936)
Timeframe: From date of randomization to date of data cut-off date of 21 January 2016; median follow-up for all participants was 17.7 months
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 26.0 |
| Lenalidomide and Dexamethasone Rd18 | 21.0 |
| Melphalan + Prednisone + Thalidomide (MPT) | 21.9 |
Kaplan-Meier Estimates of Progression-free Survival (PFS) Based on the Response Assessment by the Independent Review Adjudication Committee (IRAC)
PFS was calculated as the time from randomization to the first documented PD or death due to any cause during the study, which ever occurred first based on the International Myeloma Working Group Uniform Response criteria (IMWG). Those who withdrew for any reason or received another anti-myeloma therapy without documented PD were censored on the date of their last response assessment, prior to receiving any other anti-myeloma therapy. Censoring rules for PFS: - No baseline assessments and no progression or death documented within the 2 scheduled assessments; Death within the lst two assessments without any adequate response assessment; Progression documented between scheduled assessments; Death between adequate assessments; no progression; study discontinuations for reasons other than PD or death; new anti-myeloma started prior to PD; death or PD after an extended lost to follow-up time period (2 or more missed scheduled assessment's). (NCT00689936)
Timeframe: From date of randomization until the data cut-off date of 24 May 2013. Median follow-up time for all participants was 17.1 months.
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 25.5 |
| Lenalidomide and Dexamethasone Rd18 | 20.7 |
| Melphalan + Prednisone + Thalidomide (MPT) | 21.2 |
Shift From Baseline to Most Extreme Postbaseline Value in Platelet Count During the Active Treatment Phase.
Improvement in platelets was assessed for participants from baseline grade to most extreme severity grade using the NCI CTCAE v 3.0 grading scale. (NCT00689936)
Timeframe: Randomization to end of treatment or the data cut off of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | participants (Number) |
|---|
| Normal Baseline Grade to Normal Postbaseline Grade | Normal Baseline Grade to Grade 1 postbaseline | Normal Baseline Grade to Grade 2 postbaseline | Normal Baseline Grade to Grade 3 postbaseline | Normal Baseline Grade to Grade 4 postbaseline | Grade1 Baseline to Normal postbaseline Grade | Grade 1 Baseline to Grade 1 postbaseline | Grade 1 Baseline to Grade 2 postbaseline | Grade 1 Baseline to Grade 3 postbaseline | Grade 1 Baseline to Grade 4 postbaseline | Grade 2 Baseline to normal postbaseline Grade | Grade 2 Baseline to Grade 1 postbaseline | Grade 2 Baseline to Grade 2 postbaseline | Grade 2 Baseline to Grade 3 postbaseline | Grade 2 Baseline to Grade 4 postbaseline | Grade 3 Baseline to Normal postbaseline Grade | Grade 3 Baseline to Grade 1 postbaseline | Grade 3 Baseline to Grade 2 postbaseline | Grade 3 Baseline to Grade 3 postbaseline | Grade 3 Baseline to Grade 4 postbaseline |
|---|
| Lenalidomide and Dexamethasone Rd18 | 197 | 211 | 30 | 12 | 5 | 3 | 38 | 19 | 12 | 1 | 0 | 1 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 1 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 197 | 216 | 24 | 15 | 4 | 1 | 34 | 15 | 10 | 2 | 0 | 0 | 3 | 3 | 1 | 0 | 0 | 0 | 0 | 2 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 165 | 208 | 27 | 31 | 11 | 6 | 51 | 7 | 10 | 1 | 0 | 2 | 1 | 2 | 2 | 0 | 0 | 1 | 1 | 0 |
Percentage of Participants With a Myeloma Response by Adverse Risk Cytogenetic Risk Category Based on IRAC Review.
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | Percentage of participants (Number) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 70.0 |
| Lenalidomide and Dexamethasone Rd18 | 69.7 |
| Melphalan + Prednisone + Thalidomide (MPT) | 58.2 |
Percentage of Participants With a Myeloma Response by Normal Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | percentage of particpants (Number) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.4 |
| Lenalidomide and Dexamethasone Rd18 | 74.8 |
| Melphalan + Prednisone + Thalidomide (MPT) | 61.0 |
Percentage of Participants With a Myeloma Response by Uncertain Risk Cytogenetic Risk Category Based on IRAC Review
Participants were placed in adverse and non-adverse cytogenetic risk categories at baseline and response rates evaluated. Adverse Risk: t(4;14), t(14;16), del(13q) or monosomy 13, del(17p), 1q gain Favorable Hyperdiploidy: : t(11;14), gains of 5/9/15; Normal: a normal result, gains other than 5/9/15, IgH deletion Uncertain risk: probes used for analysis cannot place participant in any of the other risk categories. Objective response = best overall response including CR, VGPR or PR based on the IRAC Review; A CR is negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPRis serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | percentage of participants (Number) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 60.5 |
| Lenalidomide and Dexamethasone Rd18 | 76.8 |
| Melphalan + Prednisone + Thalidomide (MPT) | 57.5 |
Percentage of Participants With an Objective Response After Second-line Anti-myeloma Treatment at the Time of Final Analysis
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment; data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | percentage of participants (Number) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 46.2 |
| Lenalidomide and Dexamethasone Rd18 | 53.1 |
| Melphalan + Prednisone + Thalidomide (MPT) | 45.7 |
Number of Participants With Adverse Events (AEs) During the Active Treatment Phase
A TEAE is any AE occurring or worsening on or after the first treatment of any study drug, and within 30 days after the last dose of the last study drug. Severity grades according to Common Terminology Criteria for Adverse Events v3.0 (CTCAE) on a 1-5 scale: Grade 1= Mild AE, Grade 2= Moderate AE, Grade 3= Severe AE, Grade 4= Life-threatening or disabling AE, Grade 5=Death related to AE. A serious AE is any AE occurring at any dose that: • Results in death; • Is life-threatening; • Requires or prolongs existing inpatient hospitalization; • Results in persistent or significant disability/incapacity; • Is a congenital anomaly/birth defect; • Constitutes an important medical event. (NCT00689936)
Timeframe: From first dose of study drug through 28 days following the discontinuation visit from active treatment phase; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | Participants (Number) |
|---|
| ≥ 1 adverse event (AE) | ≥ 1 grade (Gr) 3 or 4 AE | ≥ 1 grade (Gr) 5 AE | ≥ 1 serious adverse event (SAE) | ≥ 1 AE related to Lenalidomide/Dex/Mel/Pred/Thal | ≥ 1 AE related to Lenalidomide | ≥ 1 AE related to dexamethasone | ≥ 1 AE related to melphalan | ≥ 1 AE related to prednisone | ≥ 1 AE related to thalidomide | ≥1 AE related to Lenalidomide/Dex or Mel/Pred/Thal | ≥ 1 Gr 3 or 4 AE related to Len/Dex/Mel/Pred/Thal | ≥ 1 grade 3 or 4 AE related to Lenalidomide | ≥ 1 grade 3 or 4 AE related to dexamethasone | ≥ 1 grade 3 or 4 AE related to melphalan | ≥ 1 grade 3 or 4 AE related to prednisone | ≥ 1 grade 3 or 4 AE related to Thalidomide | ≥1Gr 3 or 4 AE related to Len/Dex or Mel/Pred/Thal | ≥ 1 Grade 5 AE related to Len/Dex/Mel/Pred/Thal | ≥ 1 Grade 5 AE related to Lenalidomide | ≥ 1 Grade 5 AE related to Dexamethasone | ≥ 1 Grade 5 AE related to melphalan | ≥ 1 Grade 5 AE related to prednisone | ≥ 1 Grade 5 AE related to Thalidomide | ≥1 Grade 5 AE related to Len/Dex or Mel/Pred/Thal | ≥1 SAE related to Len/Dex/Mel/Pred/Thal | ≥1 SAE related to Lenalidomide | ≥1 SAE related to dexamethasone | ≥1 SAE related to melphalan | ≥1 SAE related to prednisone | ≥1 SAE related to thalidomide | ≥1 SAE related to Len/Dex or Mel/Pred/Thal | ≥1AE leading to Len/Dex/Mel/Pred/Thal Withdrawal | ≥1 AE leading to Lenalidomide withdrawal | ≥1 AE leading to dexamethasone withdrawal | ≥1 AE leading to melphalan withdrawal | ≥1 AE leading to prednisone withdrawal | ≥1 AE leading to Thalidomide withdrawal | ≥1AE leading to Len/DexOR Mel/Pred/Thal Withdrawal | ≥1AE leading to Len/Dex/Mel/Pred/Thal reduction | ≥1 AE leading to Lenalidomide reduction | ≥1 AE leading to dexamethasone reduction | ≥1 AE leading to melphalan reduction | ≥1 AE leading to prednisone reduction | ≥1 AE leading to thalidomide reduction | ≥1AE leading to Len/Dex or Mel/Pred/Thal reduction | ≥1 AE leading to Rd or MPT interruption | ≥1 AE leading to Lenalidomide interruption | ≥1 AE leading to dexamethasone interruption | ≥1 AE leading to melphalan interruption | ≥1 AE leading to prednisone interruption | ≥1 AE leading to Thalidomide interruption | ≥1 AE leading to Len and Dex or MPT interruption |
|---|
| Lenalidomide and Dexamethasone Rd18 | 536 | 433 | 36 | 308 | 501 | 481 | 410 | 0 | 0 | 0 | 269 | 326 | 290 | 177 | 0 | 0 | 0 | 104 | 11 | 9 | 7 | 0 | 0 | 0 | 5 | 158 | 130 | 97 | 0 | 0 | 0 | 64 | 109 | 93 | 104 | 0 | 0 | 0 | 84 | 214 | 155 | 118 | 0 | 0 | 0 | 20 | 321 | 301 | 280 | 0 | 0 | 0 | 241 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 529 | 453 | 50 | 359 | 506 | 482 | 429 | 0 | 0 | 0 | 269 | 373 | 342 | 229 | 0 | 0 | 0 | 131 | 17 | 12 | 16 | 0 | 0 | 0 | 11 | 195 | 165 | 130 | 0 | 0 | 0 | 95 | 157 | 109 | 152 | 0 | 0 | 0 | 96 | 279 | 203 | 170 | 0 | 0 | 0 | 30 | 368 | 353 | 319 | 0 | 0 | 0 | 290 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 539 | 480 | 38 | 270 | 527 | 0 | 0 | 441 | 326 | 493 | 145 | 423 | 0 | 0 | 307 | 118 | 316 | 49 | 10 | 0 | 0 | 6 | 5 | 5 | 2 | 142 | 0 | 0 | 75 | 62 | 94 | 27 | 153 | 0 | 0 | 83 | 78 | 146 | 71 | 348 | 0 | 0 | 199 | 47 | 254 | 2 | 419 | 0 | 0 | 328 | 324 | 388 | 249 |
Percentage of Participants With an Objective Response Based on Investigator Assessment at Time of Final Analysis
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined s: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | percentage of participants (Number) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 80.7 |
| Lenalidomide and Dexamethasone Rd18 | 78.6 |
| Melphalan + Prednisone + Thalidomide (MPT) | 67.5 |
Percentage of Participants With an Objective Response Based on IRAC Review
Objective response according to IMWG Uniform Response Criteria was defined as a best overall response including a complete response (CR), very good partial response (VGPR) or partial response (PR) based on the IRAC Review. A CR is defined as: negative serum and urine on immunofixation, disappearance of any soft tissue plasmacytomas and ≤5% plasma cells in BM; A VGPR is serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours; A PR is: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. If present at baseline a ≥50% reduction in size of soft tissue plasmacytomas. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | percentage of participants (Number) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 75.1 |
| Lenalidomide and Dexamethasone Rd18 | 73.4 |
| Melphalan + Prednisone + Thalidomide (MPT) | 62.3 |
Time to First Response Based on the Investigator Assessment at the Time of Final Analysis
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria assessed by the investigator. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 21 January 2016; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm.
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 |
| Lenalidomide and Dexamethasone Rd18 | 1.8 |
| Melphalan + Prednisone + Thalidomide (MPT) | 2.8 |
Time to First Response Based on the Review by the IRAC
The time to first myeloma response was defined as the time from randomization to the time when the response criteria for at least a PR was first met based on the IMWG criteria. (NCT00689936)
Timeframe: Disease response was assessed every 28 days until end of treatment or the data cut-off date of 24 May 2013; median duration of treatment was 80.2 weeks in the Rd arm; 72 weeks in the Rd18 arm and 67.1 weeks in the MPT arm
| Intervention | months (Median) |
|---|
| Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 |
| Lenalidomide and Dexamethasone Rd18 | 1.8 |
| Melphalan + Prednisone + Thalidomide (MPT) | 2.8 |
Change From Baseline in the EORTC QLQ-C30 Appetite Loss Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Appetite Loss Scale is scored between 0 and 100, with a high score indicating a higher level of appetite loss. Negative change from Baseline values indicate improvement in appetite and positive values indicate worsening of appetite. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | 2.9 | -3.3 | -8.6 | -6.4 | -5.1 | -7.5 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.3 | -5.9 | -9.8 | -7.3 | -8.1 | -1.0 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | -6.2 | -13.5 | -10.5 | -12.2 | -2.6 |
Change From Baseline in the EORTC QLQ-C30 Cognitive Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Cognitive Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1, (Baseline) then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | -1.7 | 1.8 | 0.9 | -1.2 | -2.8 | -2.6 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | -1.2 | -0.7 | -0.9 | -1.6 | -2.2 | -4.9 |
,| Melphalan + Prednisone + Thalidomide (MPT) | -1.8 | -1.5 | -0.3 | -0.6 | -0.7 | -7.1 |
Change From Baseline in the EORTC QLQ-C30 Constipation Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Constipation Scale is scored between 0 and 100, with a high score indicating a higher level of constipation. Negative change from Baseline values indicate improvement in constipation and positive values indicate worsening of constipation. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | 6.3 | 0.0 | -5.1 | -5.2 | -5.9 | -7.5 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 8.3 | 1.8 | -2.4 | -2.4 | -4.5 | -7.9 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 18.4 | 13.9 | 6.8 | 3.7 | 0.0 | -2.2 |
Change From Baseline in the EORTC QLQ-C30 Diarrhea Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Diarrhea Scale is scored between 0 and 100, with a high score indicating a higher level of diarrhea. Negative change from Baseline values indicate improvement in diarrhea and positive values indicate worsening of diarrhea. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | 2.3 | 3.4 | 6.0 | 9.1 | 10.9 | 6.4 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 3.8 | 3.7 | 8.2 | 11.8 | 14.8 | 10.8 |
,| Melphalan + Prednisone + Thalidomide (MPT) | -0.6 | -2.4 | -2.2 | -2.5 | -1.7 | -0.5 |
Change From Baseline in the EORTC QLQ-C30 Dyspnea Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Dyspnoea Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | 3.6 | -1.9 | -2.9 | -1.6 | 2.9 | 0.8 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.9 | -0.8 | -2.3 | -3.5 | -1.8 | -1.0 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 4.2 | 2.0 | 0.1 | -1.6 | 0.4 | 7.8 |
Change From Baseline in the EORTC QLQ-C30 Emotional Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Emotional Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | 0.1 | 3.9 | 5.8 | 4.9 | 3.1 | 3.7 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.6 | 3.8 | 4.6 | 4.6 | 5.8 | 2.6 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | 2.1 | 5.5 | 5.1 | 5.1 | -0.0 |
Change From Baseline in the EORTC QLQ-C30 Social Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Social Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | -2.2 | 2.0 | 5.2 | 3.8 | 3.2 | 2.7 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.3 | 0.7 | 4.0 | 2.9 | 4.2 | -1.2 |
,| Melphalan + Prednisone + Thalidomide (MPT) | -1.4 | 2.4 | 3.4 | 5.8 | 6.0 | -3.5 |
Change From Baseline in the EORTC QLQ-C30 Fatigue Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Fatigue Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | 4.4 | -3.4 | -5.9 | -2.3 | 0.1 | -1.6 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.6 | -2.5 | -3.7 | -4.3 | -3.1 | 0.3 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 2.8 | -1.8 | -4.5 | -3.9 | -4.3 | 2.7 |
Change From Baseline in the EORTC QLQ-C30 Financial Difficulties Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Financial Difficulties Scale is scored between 0 and 100, with a high score indicating a higher level of financial difficulties. Negative change from Baseline values indicate improvement in financial difficulties and positive values indicate worsening of financial difficulties. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | -0.3 | -0.4 | -0.3 | 1.6 | 1.8 | 0.5 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.1 | 1.9 | 1.4 | 0.4 | 2.0 | 1.9 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 0.5 | 1.9 | 0.7 | 1.1 | 0.4 | 5.0 |
Change From Baseline in the EORTC QLQ-C30 Insomnia Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Insomnia Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | 3.2 | -1.3 | -1.9 | 1.1 | 1.4 | -1.6 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 2.1 | 0.2 | -1.2 | -1.0 | -0.5 | -5.2 |
,| Melphalan + Prednisone + Thalidomide (MPT) | -10.5 | -8.9 | -11.6 | -9.6 | -6.0 | -4.5 |
Change From Baseline in the EORTC QLQ-C30 Nausea/Vomiting Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Nausea/Vomiting Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | -0.5 | -2.5 | -4.0 | -3.6 | -2.7 | -4.2 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 1.8 | -1.1 | -1.3 | -2.2 | -2.3 | 0.4 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 4.0 | -1.2 | -3.9 | -3.9 | -3.9 | 1.0 |
Change From Baseline in the EORTC QLQ-C30 Pain Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Pain Scale is scored between 0 and 100, with a high score indicating a higher level of symptoms. Negative change from Baseline values indicate improvement in symptoms and positive values indicate worsening symptoms. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | -4.4 | -13.1 | -16.1 | -14.7 | -12.4 | -7.9 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | -5.4 | -13.4 | -14.4 | -14.0 | -14.4 | -8.0 |
,| Melphalan + Prednisone + Thalidomide (MPT) | -7.8 | -12.1 | -13.4 | -14.3 | -14.7 | -6.0 |
Change From Baseline in the EORTC QLQ-C30 Physical Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Physical Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | -1.4 | 4.7 | 7.6 | 7.4 | 6.8 | 3.0 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | -1.7 | 3.4 | 4.7 | 5.0 | 6.9 | -0.1 |
,| Melphalan + Prednisone + Thalidomide (MPT) | -0.9 | 2.2 | 5.3 | 6.9 | 8.3 | -0.1 |
Change From Baseline in the EORTC QLQ-C30 Role Functioning Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used in clinical research to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Role Functioning Scale is scored between 0 and 100, with a high score indicating better functioning/support. Negative change from Baseline values indicate deterioration in functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | -4.6 | 6.3 | 8.6 | 9.4 | 9.1 | 3.8 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | -2.7 | 2.4 | 6.3 | 7.8 | 8.0 | -0.3 |
,| Melphalan + Prednisone + Thalidomide (MPT) | -2.4 | 4.1 | 8.2 | 11.8 | 14.5 | -1.0 |
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Cancer (EORTC QLQ-C30) Global Health Status Domain
The European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life (QOL) questionnaire (EORTC QLQ-C30) is a 30-question tool used to assess the overall quality of life in cancer patients. It consists of 15 domains: 1 global health status (GHS) scale, 5 functional scales (Physical, Role, Cognitive, Emotional, Social), and 9 symptom scales/items (Fatigue, Nausea and Vomiting, Pain, Dyspnea, Sleep Disturbance, Appetite Loss, Constipation, Diarrhea, Financial Impact). The EORTC QLQ-C30 Global Health Status/QOL scale is scored between 0 and 100, with a high score indicating better Global Health Status/QOL. Negative change from Baseline values indicate deterioration in QOL or functioning and positive values indicate improvement. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Study discontinuation |
|---|
| Lenalidomide and Dexamethasone Rd18 | -1.3 | 4.7 | 5.4 | 3.2 | 5.7 | 5.0 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | 0.4 | 4.8 | 5.9 | 4.8 | 6.4 | -0.1 |
,| Melphalan + Prednisone + Thalidomide (MPT) | 1.0 | 4.3 | 6.1 | 6.5 | 4.8 | 0.3 |
Change From Baseline in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Patients With Multiple Myeloma (EORTC QLQ-MY20) Body Image Scale
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in patients with multiple myeloma. EORTC QLQ-MY20 includes four scales: disease symptoms, treatment side-effects, future perspective, and body image. Questions used a 4-point scale (from 1 'Not at All' to 4 'Very Much'). Scores were averaged, and transformed to a 0-100 scale; for the body image scale, a higher score indicates a better body image. (NCT00689936)
Timeframe: Cycle 1 Day 1 (Baseline), then Months 1, 3, 6, 12, 18 and Discontinuation visit
| Intervention | units on a scale (Mean) |
|---|
| Month 1 | Month 3 | Month 6 | Month 12 | Month 18 | Discontinuation Visit |
|---|
| Lenalidomide and Dexamethasone Rd18 | -1.5 | 0.8 | 1.5 | -0.4 | -0.3 | 1.8 |
,| Lenalidomide and Low-Dose Dexamethasone (Rd) | -4.5 | -1.7 | -1.4 | -1.4 | -2.3 | -5.6 |
,| Melphalan + Prednisone + Thalidomide (MPT) | -1.6 | -3.0 | -2.8 | -2.6 | -1.1 | -5.6 |
Contribution of Dasatinib on Minimal Residual Disease (MRD) After Induction Therapy
Percent of patients MRD Positive (MRD > 0.01%) at End of Induction. (NCT00720109)
Timeframe: At the end of induction therapy (at 5 weeks)
| Intervention | Percentage of participants (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 40.7 |
| Standard-risk | 29.2 |
| High-risk | 100.0 |
Event-Free Survival (EFS) of Patients With Standard-risk Disease Treated With Dasatinib in Combination With Intensified Chemotherapy
Event-Free Survival (EFS) curves will be constructed using the Kaplan-Meier life table method with standard errors computed using the method of Peto and Peto. A 1-sided 95% confidence interval for EFS will be constructed. (NCT00720109)
Timeframe: At 3 years
| Intervention | Percent probability (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 79.8 |
| Standard-risk | 83.2 |
| High-risk | 66.7 |
Feasibility and Toxicity of an Intensified Chemotherapeutic Regimen Incorporating Dasatinib for Treatment of Children and Adolescents With Ph+ ALL Assessed by Examining Adverse Events
Number of patients in safety cohort with dose limiting toxicity (DLT)(including treatment delay) (NCT00720109)
Timeframe: Weeks 3 through 23 of treatment (From week 3 Induction through Intensification Block 1)
| Intervention | Pts with DLTs (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 1 |
Overall EFS Rate for the Combined Cohort of Standard- and High-Risk Patients (Who Receive the Final Chosen Dose of Dasatinib)
An event is defined as: Induction failure, relapse at any site, secondary malignancy, or death. (NCT00720109)
Timeframe: From the time entry on study to first event or date of last follow-up, assessed up to 7 years
| Intervention | percentage of patients (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 79.8 |
| Standard-risk | 83.2 |
| High-risk | 66.7 |
Percent of Patients MRD Positive (MRD > 0.01%) at End of Consolidation
A 1-sample Z-test of proportions (alpha=5%, 1-sided test) will be used. (NCT00720109)
Timeframe: At end of consolidation (at 11 weeks)
| Intervention | Percentage of participants (Number) |
|---|
| Treatment Induction (Enzyme Inhibitor Therapy & Chemotherapy) | 10.5 |
| Standard-risk | 0 |
| High-risk | 66.7 |
Cumulative Incidence of Emesis
Any vomiting or retching (NCT00734929)
Timeframe: 48 h
| Intervention | participants (Number) |
|---|
| Aprepitant | 8 |
| Ondansetron | 20 |
"Number of Participants Who Rated Their Satisfaction With Antiemetic Management as Very Satisfied"
Participants rated their satisfaction with antiemetic management on a 5 points scale: very satisfied, somewhat satisfied, neither satisfied nor dissatisfied, somewhat dissatisfied, very dissatisfied) (NCT00734929)
Timeframe: 48 hour
| Intervention | participants (Number) |
|---|
| Aprepitant | 36 |
| Ondansetron | 32 |
Average Nausea Score
Participants verbally rated their nausea on a scale of 0-10. 0 = No nausea, 10 = worst nausea imaginable (NCT00734929)
Timeframe: Post OP hours 0-2, 24 h, 48 h
| Intervention | units on a scale (Mean) |
|---|
| 0-2 hours post op | 24 hours post op | 48 hours post op |
|---|
| Aprepitant | 0.4 | 0.8 | 0.9 |
,| Ondansetron | 0.6 | 1.3 | 1.1 |
Number of Participants With a Complete Response Rate
complete response rate: defined as no Postoperative nausea and vomiting (PONV) and no need for rescue antiemetics. (NCT00734929)
Timeframe: 24 hours Post OP, 48 hours Post OP
| Intervention | participants (Number) |
|---|
| 24 Hours Post OP | 48 Hours Post OP |
|---|
| Aprepitant | 14 | 11 |
,| Ondansetron | 21 | 19 |
Incidence of Nausea
operative procedure (NCT00734929)
Timeframe: Post operative procedure (OP) hours (0-2, 24, 48)
| Intervention | participants (Number) |
|---|
| 0-2 hours Post OP | 24 Hours Post Op | 48 Hours Post Op |
|---|
| Aprepitant | 27 | 33 | 35 |
,| Ondansetron | 27 | 30 | 32 |
Use of Rescue Antiemetics (Post OP)
(NCT00734929)
Timeframe: Post OP (0 - 2 hours)
| Intervention | participants (Number) |
|---|
| Aprepitant | 20 |
| Ondansetron | 24 |
Use of Rescue Antiemetics (48 Hours)
(NCT00734929)
Timeframe: 48 hour
| Intervention | participants (Number) |
|---|
| Aprepitant | 33 |
| Ondansetron | 32 |
Use of Rescue Antiemetics (24 Hours)
(NCT00734929)
Timeframe: 24 h
| Intervention | participants (Number) |
|---|
| Aprepitant | 31 |
| Ondansetron | 30 |
Time to First Vomiting
(NCT00734929)
Timeframe: 48 h
| Intervention | hours (Median) |
|---|
| Aprepitant + Dexamethasone | 13.5 |
| Ondansetron + Dexamethasone | 2 |
Number of Vomiting Episodes
(NCT00734929)
Timeframe: 48 hours
| Intervention | vomiting episodes (Mean) |
|---|
| Aprepitant | 0 |
| Ondansetron | 0 |
Incidence of Vomiting (Post OP)
(NCT00734929)
Timeframe: Post OP (0 - 2 hours)
| Intervention | participants (Number) |
|---|
| Aprepitant | 3 |
| Ondansetron | 11 |
Incidence of Vomiting (24 Hours)
Any vomiting or retching (NCT00734929)
Timeframe: 24 h
| Intervention | participants (Number) |
|---|
| Aprepitant | 7 |
| Ondansetron | 19 |
Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Lenalidomide and Dexamethasone (Phase 1)
MTD was determined by testing increasing doses up to 20 mg/kg once daily dose escalation cohorts 1 to 3 with 3 patients each. MTD reflects highest dose of drug that did not cause an unacceptable side effect (dose limiting toxicity [DLT]) in more than 30% of patients; e.g., hematologic toxicities like Common Toxicity Criteria for Adverse Events (CTCAE) Grade 4 neutropenia in specific conditions, platelets < 10,000 cells/mm^3 that do not recover to 25,000 cells/mm^3; and specific non-hematologic/biochemical toxicities CTCAE Grade 3 or 4 (except fatigue and Grade 3 infections); CTCAE version 3.0 were used. (NCT00742560)
Timeframe: 4 weeks
| Intervention | mg/kg (Number) |
|---|
| Phase 1 Elotuzumab + Lenalidomide and Dexamethasone | 20 |
Duration of Response
Duration of response is defined as the time from the initial objective response to disease progression or death, whichever occurs first. The distribution of duration of response was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the duration of response distribution are provided. (NCT00742560)
Timeframe: From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
| Intervention | months (Median) |
|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 4.47 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 9.92 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | NA |
| Total (Phase 1) | NA |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 34.83 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 29.01 |
| Total (Phase 2) | 29.24 |
Time to Progression (TTP)
TTP is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression. The distribution of TTP was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the TTP distribution are provided. (NCT00742560)
Timeframe: From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
| Intervention | months (Median) |
|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 6.08 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 11.53 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 52.93 |
| Total (Phase 1) | 52.93 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 32.49 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 19.94 |
| Total (Phase 2) | 28.16 |
Percentage of Participants With Treatment-emergent Anti-elotuzumab Antibody (ADA)
Treatment-emergent (post-dose) positive elotuzumab-specific ADA is differentiated from pre-existing (positive at the predose time point) positive elotuzumab-specific ADA. The percentage of participants with confirmed treatment-emergent ADA overall by dose is provided. (NCT00742560)
Timeframe: From screening through 60-day follow up period (up to 101 months)
| Intervention | percentage of participants (Number) |
|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone | 0 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone | 6 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone | 5 |
Progression-free Survival (PFS)
PFS is defined as the time from first dose (phase 1) or time from randomization (phase 2) to disease progression or death. The distribution of PFS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the median for the PFS distribution are provided. (NCT00742560)
Timeframe: From first dose of elotuzumab (phase 1) or randomization (phase 2) until 60 days following the last infusion (or before initiation of new therapy), up to 101 months
| Intervention | months (Median) |
|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 6.08 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 22.23 |
| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | NA |
| Total (Phase 1) | 32.92 |
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 32.49 |
| Elotuzumab 10 mg/kg Administered as an IV Infusion in Combinat | 25.00 |
| Total (Phase 2) | 28.62 |
Mean Serum Concentrations of Elotuzumab During Cycle 1
Blood samples were collected during Phase 1, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours) and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). Blood samples were collected during Phase 2, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) and 2 hours post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). The samples were analyzed for the concentration of elotuzumab using validated analytical methods. Mean serum concentrations on Cycle 1, Days 1, 8, 15, and 22 (measured in μg/mL) are reported overall (across Phase 1 and Phase 2) by dose. (NCT00742560)
Timeframe: Cycle 1: Days 1 (pre-infusion and 0.5, 2 and 4 hours post-infusion), 8 (pre-infusion and 0.5 and 2 hours post-infusion), 15 (pre-infusion and 0.5 hours and 2 hours post-infusion), and 22 (pre-infusion and 0.5, 2, and 4 hours post-infusion)
| Intervention | μg/mL (Mean) |
|---|
| Day 1: 0 hours | Day 1: 0.5 hours | Day 1: 4 hours | Day 8: 0 hours | Day 8: 0.5 hours | Day 15: 0 hours | Day 15: 0.5 hours | Day 22: 0 hours | Day 22: 0.5 hours | Day 22: 2 hours | Day 22: 4 hours |
|---|
| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone | 0.00 | 78.48 | 85.56 | 32.44 | 133.37 | 49.84 | 140.09 | 61.93 | 168.61 | 268.53 | 128.94 |
Mean Serum Concentrations of Elotuzumab During Cycle 1
Blood samples were collected during Phase 1, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours) and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). Blood samples were collected during Phase 2, Cycle 1, prior to elotuzumab infusion (time 0 hours) and 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 1), 30 minutes (0.5 hours) and 2 hours post-infusion (Day 8 and Day 15), or 30 minutes (0.5 hours), 2 hours, and 4 hours post-infusion (Day 15). The samples were analyzed for the concentration of elotuzumab using validated analytical methods. Mean serum concentrations on Cycle 1, Days 1, 8, 15, and 22 (measured in μg/mL) are reported overall (across Phase 1 and Phase 2) by dose. (NCT00742560)
Timeframe: Cycle 1: Days 1 (pre-infusion and 0.5, 2 and 4 hours post-infusion), 8 (pre-infusion and 0.5 and 2 hours post-infusion), 15 (pre-infusion and 0.5 hours and 2 hours post-infusion), and 22 (pre-infusion and 0.5, 2, and 4 hours post-infusion)
| Intervention | μg/mL (Mean) |
|---|
| Day 1: 0 hours | Day 1: 0.5 hours | Day 1: 2 hours | Day 1: 4 hours | Day 8: 0 hours | Day 8: 0.5 hours | Day 8: 2 hours | Day 15: 0 hours | Day 15: 0.5 hours | Day 22: 0 hours | Day 22: 0.5 hours | Day 22: 2 hours | Day 22: 4 hours |
|---|
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone | 0.00 | 217.90 | 213.31 | 251.34 | 92.47 | 281.53 | 268.35 | 111.11 | 282.29 | 135.92 | 310.03 | 298.85 | 538.88 |
,| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone | 0.00 | 434.20 | 388.58 | 525.98 | 168.55 | 593.80 | 520.97 | 298.82 | 661.91 | 308.02 | 699.70 | 704.48 | 981.16 |
Number of Participants With Infusion Reactions
During Phase 1, a list of 118 pre-defined MedDRA preferred terms that had been adjudicated to be clinically relevant to infusion reactions by a safety committee was used to search for TEAEs that could potentially be associated with an infusion reaction following elotuzumab administration. Examples of these terms included angioedema, bronchospasm, chills, flushing, pyrexia, rash and urticaria. During Phase 2, the method for capturing TEAEs associated with an infusion reaction was modified to include investigators' designation of AEs judged as clinically relevant infusion reactions. The number of participants infusion reactions are provided overall and by highest toxicity grade (CTCAE v 3.0). (NCT00742560)
Timeframe: Cycles 1 and 2: Days 1, 8, 15, and 22 (day of infusion of elotuzumab) and Days 2, 9, 16, and 23 (day following infusion); and Cycles 3 and greater: Days 1 and 15 (day of infusion) and Days 2 and 16 (day after infusion) (up to 95 months)
| Intervention | participants (Number) |
|---|
| Any reaction | Grade 5 | Grade 4 | Grade 3 | Grade 2 | Grade 1 |
|---|
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 | 0 | 0 | 0 | 1 | 2 |
,| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 5 | 0 | 0 | 1 | 1 | 3 |
,| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 20 | 0 | 1 | 2 | 5 | 12 |
,| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 3 | 0 | 0 | 0 | 1 | 2 |
,| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 2 | 0 | 0 | 0 | 0 | 2 |
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either definitely related, probably related, possibly related or unrelated. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent events (TEAEs/TESAEs) are defined as any event that began or worsened in severity after the first dose of study drug. For more details on adverse events please see the Adverse Event section. (NCT00742560)
Timeframe: Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from first dose of study drug until 60 days after the last dose of study drug (up to 95 months)
| Intervention | participants (Number) |
|---|
| Any TEAE | Any TESAE | TEAEs ≥ Grade 3 | TEAEs related to study drug | TESAEs related to study drug |
|---|
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 | 3 | 3 | 3 | 0 |
,| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 36 | 21 | 32 | 29 | 2 |
,| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 22 | 12 | 19 | 16 | 2 |
,| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 37 | 21 | 25 | 26 | 5 |
,| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 3 | 0 | 2 | 3 | 0 |
Plasma Cell Myeloma Cytogenetic Subtype
Plasma cell myeloma cytogenetic subtype was assessed at the screening visit using standard karyotyping and/or fluorescence in situ hybridization. The number of participants in each cytogenetic risk category are provided: High Risk (International Staging System [ISS] stage II or III and t(4;14) or del(17p) abnormality); Standard Risk (not high or low risk); and Low Risk (ISS stage I or II and absence of t(4;14), del(17p) and 1q21 abnormalities AND age < 55). (NCT00742560)
Timeframe: Screening (up to 14 days prior to dosing)
| Intervention | participants (Number) |
|---|
| High Risk | Standard Risk | Low Risk | Not Reported |
|---|
| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | 3 | 0 | 0 |
,| Elotuzumab 10 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 1 | 30 | 2 | 3 |
,| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 0 | 17 | 3 | 2 |
,| Elotuzumab 20 mg/kg + Lenalidomide and Dexamethasone (Phase 2) | 3 | 24 | 3 | 7 |
,| Elotuzumab 5 mg/kg + Lenalidomide and Dexamethasone (Phase 1) | 1 | 2 | 0 | 0 |
Response Rate to Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphoma With Rituximab Resistance
Response rate is defined as a complete response or partial response using anatomic criteria of the International Workshop Response Critieria (Cheson, 1999). (NCT00783367)
Timeframe: 3 months
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1 | 14 |
| Cohort 2 | 13 |
Time Until Progression After Lenalidomide-dexamethasone + Rituximab Therapy in Relapsed Small B-cell Lymphomas With Rituximab Resistance
Progression free survival time in months (NCT00783367)
Timeframe: 9 years from enrollment of first subject
| Intervention | months (Median) |
|---|
| Cohort 1 | 22.2 |
| Cohort 2 | 22.4 |
Overall Survival (OS)
OS will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: From the date of initial registration on the study until death from any cause, assessed up to 5 years
| Intervention | Probability of surviving 12 months (Number) |
|---|
| Treatment | 0.88 |
Relapse-free Survival (RFS) After Allogeneic Stem Cell Transplantation
Will be estimated using the method of Kaplan-Meier. (NCT00792948)
Timeframe: 12 months
| Intervention | Probability of 12-month RFS (Number) |
|---|
| Treatment | 0.83 |
Continuous Complete Remission (CCR) Rate
Will be testing using an exact binomial test (NCT00792948)
Timeframe: 18 months
| Intervention | percentage of participants (Number) |
|---|
| Treatment | 57 |
Progression Free Survival (PFS) as Assessed by Central Independent Review
"Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier).~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve." (NCT00806819)
Timeframe: From randomisation until cut-off date 9 July 2012
| Intervention | months (Median) |
|---|
| Nintedanib Plus Pemetrexed | 4.4 |
| Placebo Plus Pemetrexed | 3.6 |
Overall Survival (Key Secondary Endpoint)
Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | months (Median) |
|---|
| Nintedanib Plus Pemetrexed | 12.0 |
| Placebo Plus Pemetrexed | 12.7 |
Duration of Confirmed Objective Tumour Response
"The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | Months (Median) |
|---|
| central independent reviewer (N=32, 30) | Investigator assessment (N=53, 48) |
|---|
| Nintedanib Plus Pemetrexed | 6.9 | 6.5 |
,| Placebo Plus Pemetrexed | 4.4 | 7.2 |
Disease Control
"Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0.~This endpoint was analysed based on the central independent reviewer as well as the investigator." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | % of participants (Number) |
|---|
| Central independent review (N=215, 192) | Investigator assessment (N=233, 217) |
|---|
| Nintedanib Plus Pemetrexed | 60.9 | 66.0 |
,| Placebo Plus Pemetrexed | 53.3 | 60.3 |
Change From Baseline in Tumour Size
Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (adenocarcinoma vs. non-adenocarcinoma), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator. (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | percentage of change in tumor size in mm (Mean) |
|---|
| Central independent review (N=298, 305) | Investigator assessment (N=322, 325) |
|---|
| Nintedanib Plus Pemetrexed | -10.10 | -15.60 |
,| Placebo Plus Pemetrexed | -7.53 | -11.28 |
Clinical Improvement.
"Clinical improvement was defined as the time from randomisation to deterioration in body weight and/or Eastern Cooperative Oncology group performance score (ECOG PS) whichever occurred first.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | Months (Median) |
|---|
| Nintedanib Plus Pemetrexed | 7.2 |
| Placebo Plus Pemetrexed | 7.5 |
Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review
Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | Months (Median) |
|---|
| Nintedanib Plus Pemetrexed | 4.4 |
| Placebo Plus Pemetrexed | 3.4 |
Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator
Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | Months (Median) |
|---|
| Nintedanib Plus Pemetrexed | 5.3 |
| Placebo Plus Pemetrexed | 4.3 |
Incidence and Intensity of Adverse Events
"Incidence and intensity of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. The worst CTCAE grade per patient is reported and MedDRA version 15.1 used.~Serious signs and symptoms of progressive disease were reported as an adverse event in analysis of this endpoint." (NCT00806819)
Timeframe: From the first drug administration until 28 days after the last drug administration, up to 36 months
| Intervention | % of participants (Number) |
|---|
| CTCAE grade 1 | CTCAE grade 2 | CTCAE grade 3 | CTCAE grade 4 | CTCAE grade 5 |
|---|
| Nintedanib Plus Pemetrexed | 4.9 | 22.2 | 46.1 | 12.4 | 9.8 |
,| Placebo Plus Pemetrexed | 9.2 | 30.5 | 34.5 | 7.8 | 12.0 |
Time to Confirmed Objective Tumour Response
"Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | Months (Median) |
|---|
| Central independent review (N=32, 30) | Investigator assessment (N=53, 48) |
|---|
| Nintedanib Plus Pemetrexed | 2.6 | 2.6 |
,| Placebo Plus Pemetrexed | 2.7 | 2.8 |
Quality of Life (QoL)
"QoL was measured by standardised questionnaires (EQ-5D, EORTC QLQ-C30, EORTC QLQ-LC13). The EORTC QLQ-C30 comprises of 30 questions, using both multi-item scales and single-item measures. EORTC LC-13 comprises of 13 questions incorporating 1 multi-item scale and a series of single items. The following were the main points of interest: Time to deterioration of cough (QLQ-LC13 question 1), Time to deterioration of dyspnoea (QLQ-LC13, composite of questions 3 to 5), Time to deterioration of pain (QLQ- C30, composite of questions 9 and 19). Time to deterioration of cough, dyspnoea and pain was defined as the time to a 10-point increase from the baseline score.~Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | Months (Median) |
|---|
| Time to deterioration of cough | Time to deterioration of dyspnoea | Time to deterioration of pain |
|---|
| Nintedanib Plus Pemetrexed | 6.0 | 2.4 | 2.8 |
,| Placebo Plus Pemetrexed | 4.3 | 2.0 | 2.7 |
Objective Tumor Response
Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. This endpoint was analysed based on the central independent reviewer as well as the investigator (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | % of participants (Number) |
|---|
| Central independent reviewer | Investigator assessment |
|---|
| Nintedanib Plus Pemetrexed | 9.1 | 15.0 |
,| Placebo Plus Pemetrexed | 8.3 | 13.3 |
Duration of Disease Control
"The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve.~This endpoint was analysed based on the central independent reviewer as well as the investigator." (NCT00806819)
Timeframe: From randomisation until data cut-off (15 February 2013), Up to 30 months
| Intervention | Months (Median) |
|---|
| Central independent review (N=215, 192) | Investigator assessment (N=233, 217) |
|---|
| Nintedanib Plus Pemetrexed | 7.4 | 6.9 |
,| Placebo Plus Pemetrexed | 6.8 | 6.8 |
Overall Survival
(NCT00807599)
Timeframe: up to 4 years
| Intervention | percentage of participants alive (Number) |
|---|
| Continue Lenalidomide and Dexamethasone | 95.7 |
| Stem Cell Transplant x 1 or x 2 | 90.6 |
Progression Free Survival (PFS) Rate at 2 Years After Enrollment in Untreated Patients With Multiple Myeloma.
(NCT00807599)
Timeframe: 2 years
| Intervention | percentage of participants (Number) |
|---|
| Continue Lenalidomide and Dexamethasone | 84.6 |
| Stem Cell Transplant x 1 or x 2 | 83.3 |
Phase 2: Kaplan-Meier Estimates of Progression-free Survival (PFS) as of the 01 April 2011 Cut-off
"Progression free survival (PFS) is the time from randomization to the first documentation of disease progression or death from any cause during study, whichever occurs earlier. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~For the primary PFS analysis, participants who withdrew for any reason or received another antimyeloma therapy (except adding dexamethasone to the Phase 2: Pomalidomide arm) without documented PD (as determined by the IRAC review) were censored on the date of their last adequate response assessment, prior to receiving any other anti-myeloma therapy. Subjects who were still active at the time of the data cut-off date without PD (as determined by the IRAC) were censored on the date of their last adequate response assessment.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 67 weeks
| Intervention | weeks (Median) |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 16.6 |
| Phase 2: Pomalidomide | 10.7 |
Phase 1: Participants With Dose-Limiting Toxicities (DLT) in Cycle 1
"The maximum tolerated dose was defined as the highest dose level at which no more than 1 of 6 participants experiences a DLT within the first 28-day cycle.~DLTs were defined as:~Grade 4 neutropenia or thrombocytopenia~Febrile neutropenia~Grade 3 or 4 nausea, vomiting or diarrhea despite optimal symptomatic treatment~Serum transaminase > 20 * upper limit of normal (ULN)~Serum transaminase > 5 * ULN for >= 7 days~Delay of the start of cycle 2 by >7 days due to pomalidomide-related adverse event" (NCT00833833)
Timeframe: Up to Day 28 (Cycle 1)
| Intervention | participants (Number) |
|---|
| Phase 1: 2 mg Pomalidomide | 1 |
| Phase 1: 3 mg Pomalidomide | 1 |
| Phase 1: 4 mg Pomalidomide | 2 |
| Phase 1: 5 mg Pomalidomide | 4 |
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Single-Agent Pomalidomide as of the 01 April 2011 Cut-off
"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: Up to week 104
| Intervention | percentage of participants (Number) |
|---|
| 1 or more (1+) AE | 1+ AE related to pomalidomide | 1+ severity grade 3-4 AE | 1+ severity grade 3-4 AE related to pomalidomide | 1+ serious AE (SAE) | 1+ SAE related to pomalidomide | 1+ AE leading to discontinuation of pomalidomide | 1+AE-dose reduction/interruption of pomalidomide | 1+related AE-reduction/interruption of pomalidomid |
|---|
| Phase 1: 2 mg Pomalidomide | 100.0 | 66.7 | 83.3 | 33.3 | 50.0 | 0.0 | 16.7 | 16.7 | 0.0 |
,| Phase 1: 3 mg Pomalidomide | 100.0 | 75.0 | 37.5 | 25.0 | 12.5 | 12.5 | 0.0 | 75.0 | 37.5 |
,| Phase 1: 4 mg Pomalidomide | 100.0 | 85.7 | 78.6 | 42.9 | 42.9 | 7.1 | 21.4 | 42.9 | 28.6 |
,| Phase 1: 5 mg Pomalidomide | 100.0 | 100.0 | 80.0 | 70.0 | 30.0 | 10.0 | 0.0 | 80.0 | 70.0 |
Phase 2: Kaplan-Meier Estimates of Overall Survival as of the 01 April 2011 Cut-off
"Overall survival was defined as the time between randomization and death. Participants who die, regardless of the cause of the death, were considered to have had an event. All participants who were lost to follow-up prior to the end of the trial or who were withdrawn from the trial were censored at the time of last contact. Participants who were still being treated were censored at the last available date the subject was known to be alive, or clinical cut-off date if it was earlier.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 70 weeks
| Intervention | weeks (Median) |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 62.6 |
| Phase 2: Pomalidomide | 59.3 |
Phase 2: Kaplan-Meier Estimates of Duration of Response as of the 01 April 2011 Cut-off
"Duration of myeloma response is defined as the time from when the response criteria are first met for partial response (PR) or better, until the first date the response criteria are met for progressive disease (PD) or until the participant dies from any cause, whichever occurs first. Duration of response for participants last known to be alive with no progression after a complete response (CR) or PR was censored at the date of last adequate response assessment. Participants with confirmed responses that occur after receiving any other anti-myeloma therapy (except for adding dexamethasone to the pomalidomide treatment arm), including radiation therapy initiated after baseline, was censored at the last adequate assessment prior to the initiation of such treatment.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described in the previous outcome." (NCT00833833)
Timeframe: up to 70 weeks
| Intervention | weeks (Median) |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 32.1 |
| Phase 2: Pomalidomide | NA |
Phase 2: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) as of the 01 April 2011 Cut-off
"Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: Up to week 70
| Intervention | percentage of participants (Number) |
|---|
| 1 or more (1+) AE | 1+ AE related to pomalidomide | 1+ severity grade 3-4 AE | 1+ severity grade 3-4 AE related to pomalidomide | 1+ serious AE (SAE) | 1+ SAE related to pomalidomide | 1+ AE leading to discontinuation of pomalidomide | 1+related AE --discontinuation of pomalidomide | 1+AE - reduction of pomalidomide | 1+ AE - interruption of pomalidomide | 1+ related AE - interruption of pomalidomide | 1+related AE - reduction of pomalidomide |
|---|
| Phase 2: Pomalidomide (Overall) | 100.0 | 88.8 | 89.7 | 67.3 | 67.3 | 20.6 | 12.1 | 3.7 | 29.9 | 58.9 | 32.7 | 24.3 |
,| Phase 2: Pomalidomide (Pom + Dex Only) | 93.4 | 68.9 | 70.5 | 44.3 | 47.5 | 19.7 | 3.3 | 1.6 | 9.8 | 36.1 | 21.3 | 8.2 |
,| Phase 2: Pomalidomide (Pom Only) | 99.1 | 87.9 | 84.1 | 58.9 | 46.7 | 9.3 | 10.3 | 2.8 | 25.2 | 47.7 | 24.3 | 20.6 |
,| Phase 2: Pomalidomide + Dexamethasone | 100.0 | 89.3 | 88.4 | 62.5 | 61.6 | 17.9 | 8.0 | 1.8 | 20.5 | 63.4 | 27.7 | 17.9 |
Phase 2: Summary of Best Myeloma Response As Assessed by Independent Response Adjudication Committee (IRAC) Using European Group for Blood and Bone Marrow Transplant (EBMT) Criteria as of the 01 April 2011 Cut-off
"IRAC used EBMT criteria to assess myeloma response:~Complete Response (CR)-absence of serum and urine monoclonal paraprotein for 6 weeks, plus no increase in size or number of lytic bone lesions, plus other factors)~Partial Response (PR)-not all CR criteria, plus >=50% reduction in serum monoclonal paraprotein plus others~Minimal Response (MR)- 25-49% reduction in serum monoclonal paraprotein plus others~Stable Disease (SD)- not MR or progressive disease (PD)~Progressive Disease (PD)- reappearance of monoclonal paraprotein, lytic bone lesions, other~Not Evaluable (NE).~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 70 weeks
| Intervention | percentage of participants (Number) |
|---|
| Complete response (CR) | Partial response (PR) | Minimal response (MR) | Stable disease (SD) | Progressive disease (PD) | Not evaluable |
|---|
| Phase 2: Pomalidomide | 0.0 | 9.3 | 15.7 | 46.3 | 15.7 | 13.0 |
,| Phase 2: Pomalidomide + Dexamethasone | 0.9 | 29.2 | 15.0 | 35.4 | 6.2 | 13.3 |
Phase 2: Percentage of Participants With Progression-Free Survival (PFS) Events as of the 01 April 2011 Cut-off
"Percentage of participants with the progression-free survival events: disease progression and death. Disease progression was assessed by the Independent Response Adjudication Committee (IRAC).~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 67 weeks
| Intervention | percentage of participants (Number) |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 76.1 |
| Phase 2: Pomalidomide | 75.0 |
Phase 2: Time to Response as of the 01 April 2011 Cut-off
"Time to myeloma response is defined as the time from randomization to the time the response criteria for complete response (CR) or partial response (PR) are first met.~Response was assessed by the Independent Response Adjudication Committee (IRAC) using European Group for Blood and Bone Marrow Transplant (EBMT) criteria as described previously.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: up to 70 weeks
| Intervention | weeks (Median) |
|---|
| Phase 2: Pomalidomide + Dexamethasone | 8.1 |
| Phase 2: Pomalidomide | 8.9 |
Phase 1: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) While on Both Pomalidomide and Dexamethasone as of the 01 April 2011 Cut-off
"TEAEs that occurred during Phase 1 after dexamethasone was added to pomalidomide treatment.~Relation to study drug was assessed by the Investigator as either suspected or not suspected. Counts represent the suspected relationship. Severity was assessed using National Cancer Institute Common Toxicity Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0): 1= Mild 2= Moderate 3= Severe 4= Life-threatening and 5= Death related to AE. Serious AEs (SAEs) are those that resulted in death, were life-threatening, required or prolonged inpatient hospitalization, resulted in persistent or significant disability/incapacity, congenital anomaly, or resulted in an important medical event that may have jeopardized the patient or required medical or surgical intervention to prevent one of the outcomes listed above.~Data collection is ongoing and future data results will be included as available." (NCT00833833)
Timeframe: Up to week 126
| Intervention | percentage of participants (Number) |
|---|
| 1 or more (1+) AE | 1+ AE related to pomalidomide | 1+ AE related to dexamethasone | 1+ severity grade 3-4 AE | 1+ severity grade 3-4 AE related to pomalidomide | 1+ severity grade 3-4 AE related to dexamethasone | 1+ serious AE (SAE) | 1+ SAE related to pomalidomide | 1+ SAE related to dexamethasone | 1+ AE leading to discontinuation of pomalidomide | 1+ AE -- discontinuation of dexamethasone | 1+AE -dose reduction/interruption of pomalidomide | 1+ AE-dose reduction/interruption of dexamethasone | 1+related AE-reduction/interruption of pomalidomid | 1+related AE-reduction/interruption of dexamethaso |
|---|
| Phase 1: 2 mg Pomalidomide | 100.0 | 100.0 | 100.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 | 0.0 |
,| Phase 1: 3 mg Pomalidomide | 100.0 | 75.0 | 75.0 | 75.0 | 75.0 | 75.0 | 75.0 | 25.0 | 50.0 | 25.0 | 25.0 | 50.0 | 75.0 | 25.0 | 75.0 |
,| Phase 1: 4 mg Pomalidomide | 90.0 | 80.0 | 70.0 | 70.0 | 20.0 | 20.0 | 40.0 | 20.0 | 10.0 | 20.0 | 20.0 | 40.0 | 60.0 | 20.0 | 20.0 |
,| Phase 1: 5 mg Pomalidomide | 100.0 | 100.0 | 85.7 | 57.1 | 42.9 | 0.0 | 28.6 | 0.0 | 0.0 | 0.0 | 0.0 | 71.4 | 71.4 | 57.1 | 42.9 |
AALL08P1 Safety Outcome
Percentage of Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol. (NCT00866307)
Timeframe: Consolidation through Delayed Intensification
| Intervention | percentage of participants (Number) |
|---|
| Group B (High Risk-High) | 50.0 |
AALL08P1 Feasibility Outcome
Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol. (NCT00866307)
Timeframe: Consolidation through Delayed Intensification
| Intervention | percentage of participants (Number) |
|---|
| Group B (High Risk-High) | 53.3 |
Duration of Response
Assessed as the median value for the time from first partial response until progression; death; or last follow-up. (NCT00890552)
Timeframe: 32 months
| Intervention | months (Median) |
|---|
| Lenalidomide, Melphalan and Dexamethasone (MDR) | 9.1 |
Event-free Survival (EFS)
Assessed as the median value for EFS 12 months after starting MDR treatment (NCT00890552)
Timeframe: 12 months
| Intervention | months (Median) |
|---|
| Lenalidomide, Melphalan and Dexamethasone (MDR) | 3.15 |
Overall Survival (OS)
Participants alive 12 months after starting MDR treatment. (NCT00890552)
Timeframe: 12 months
| Intervention | percentage of participants (Number) |
|---|
| Lenalidomide, Melphalan and Dexamethasone (MDR) | 58 |
Hematologic Response Rate
At the end of each treatment cycle (4 weeks), hematologic response rate as assessed. Hematologic response was considered to be amyloid complete response (normal FLC ratio and negative serum and urine immunofixation); very good partial response (difference between involved and uninvolved FLCs [dFLC] < 40 mg/L); or partial response (dFLC decrease > 50%). (NCT00890552)
Timeframe: 8 weeks
| Intervention | participants (Number) |
|---|
| Complete Response (CR) | Very good Partial Response (VGPR) | Partial Response (PR) | No Response (NR) | Response not evaluable |
|---|
| Lenalidomide, Melphalan and Dexamethasone (MDR) | 2 | 4 | 8 | 9 | 1 |
Occurrence of a Dose-Limiting Toxicity
The MTD in each stratum will be the highest dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy. (NCT00928200)
Timeframe: Beginning with the first dose of investigational product until 30 days following the last dose of Erwinase
| Intervention | Participants (Count of Participants) |
|---|
| Single Arm | 0 |
Complete Response Rate
A Complete Response (CR): defined as no nausea, no vomiting/retching, no rescue medication and no withdrawal of consent from the time of administration of the study drug(s) until 72 hours post emergence from anesthesia. (NCT00952133)
Timeframe: Pre-op through 72 hours post emergence from anesthesia
| Intervention | participants (Number) |
|---|
| 0-2 Hours - no rescue medication | 0-6 Hours - no rescue medication | 0-72 Hours - no rescue medication |
|---|
| Palonosetron Only | 38 | 32 | 26 |
,| Palonosetron With Dexamethasone | 38 | 32 | 32 |
Number of Participants Who Experienced no or Reduced Post-Operative Nausea Vomiting (PONV) the First 96 Hours After Surgery
Participants with no or reduced post operative nausea over a 96 hour period after surgery. questionnaires answered after surgery at 2 hour, 6 hour, 12 hour 72 hour and 96 hours post surgery. (NCT00952133)
Timeframe: Pre-op through 96 hours post-op
| Intervention | participants (Number) |
|---|
| Dexamethasone | 32 |
| Placebo | 26 |
Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1
"Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy." (NCT00952341)
Timeframe: 25 to 120 hours
| Intervention | Proportion of participants (Number) |
|---|
| Aprepitant (MK-0869) | 0.740 |
| Placebo | 0.594 |
Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1
"Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy." (NCT00952341)
Timeframe: 0 to 120 hours
| Intervention | Proportion of participants (Number) |
|---|
| Aprepitant (MK-0869) | 0.696 |
| Placebo | 0.570 |
Proportion of Participants With No Impact on Daily Life in Cycle 1
"The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best)." (NCT00952341)
Timeframe: 0 to 120 hours
| Intervention | Proportion of participants (Number) |
|---|
| Aprepitant (MK-0869) | 0.705 |
| Placebo | 0.683 |
Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1
Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy (NCT00952341)
Timeframe: 25 to 120 hours
| Intervention | Proportion of participants (Number) |
|---|
| Aprepitant (MK-0869) | 0.740 |
| Placebo | 0.594 |
Proportion of Participants With Complete Response in the Acute Phase of Cycle 1
"Acute phase was defined as 0 to 24 hours following initiation of chemotherapy.~Complete response was defined as no vomiting with no rescue therapy." (NCT00952341)
Timeframe: 0 to 24 hours
| Intervention | Proportion of participants (Number) |
|---|
| Aprepitant (MK-0869) | 0.794 |
| Placebo | 0.793 |
Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1
Acute Phase was defined as 0 to 24 hours following initiation of chemotherapy. (NCT00952341)
Timeframe: 0 to 24 hours
| Intervention | Proportion of participants (Number) |
|---|
| Aprepitant (MK-0869) | 0.804 |
| Placebo | 0.798 |
Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1
"Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.~No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy)." (NCT00952341)
Timeframe: 0 to 120 hours
| Intervention | Proportion of participants (Number) |
|---|
| Aprepitant (MK-0869) | 0.706 |
| Placebo | 0.570 |
Time to First Vomiting Episode in Cycle 1
Time from administration of chemotherapy to first vomiting episode. (NCT00952341)
Timeframe: 0 to 120 hours
| Intervention | Hours (Mean) |
|---|
| Aprepitant (MK-0869) | 77.0 |
| Placebo | 76.0 |
Incidence of Adverse Events
Linear regression was utilized to assess the effect of patient prognostic factors on the toxicity rate. (NCT00966693)
Timeframe: Up to 9 years
| Intervention | Participants (Count of Participants) |
|---|
| RTD (Cohort 1, Phase 1) | 0 |
| RTD (Cohort 2, Phase 1) | 0 |
| RTD (Cohort 3, Phase 1) | 2 |
| RTD (Cohort 2, Phase 2) | 10 |
Progression Free Survival
Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups was made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes. (NCT00966693)
Timeframe: Up to 9 years
| Intervention | Months (Mean) |
|---|
| RTD (Cohort 1, Phase 1) | 32.74 |
| RTD (Cohort 2, Phase 1) | 9.04 |
| RTD (Cohort 3, Phase 1) | 14.61 |
| RTD (Cohort 2, Phase 2) | 10.02 |
Number of Participants With Dose Limitations Toxicities of the Combination of Lenalidomide and Thalidomide and Dexamethasone (LTD) in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)
To determine the dose limitations toxicities of the combination of lenalidomide and thalidomide and dexamethasone (LTD) in patients with relapsed/refractory multiple myeloma (RRMM). (NCT00966693)
Timeframe: After one 28-day cycle
| Intervention | Participants (Count of Participants) |
|---|
| RTD (Cohort 1, Phase 1) | 1 |
| RTD (Cohort 2, Phase 1) | 0 |
| RTD (Cohort 3, Phase 1) | 3 |
| RTD (Cohort 2, Phase 2) | 0 |
Time to Best Response
Estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups was made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes. (NCT00966693)
Timeframe: Up to 9 years
| Intervention | months (Mean) |
|---|
| RTD (Cohort 1, Phase 1) | 19 |
| RTD (Cohort 2, Phase 1) | 5 |
| RTD (Cohort 3, Phase 1) | 5.16 |
| RTD (Cohort 2, Phase 2) | 3.3 |
Time to Next Therapy
Estimated using the method of Kaplan and Meier. (NCT00966693)
Timeframe: Up to 4.5 years
| Intervention | months (Median) |
|---|
| RTD (Cohort 1, Phase 1) | 52.4 |
| RTD (Cohort 2, Phase 1) | 14.3 |
| RTD (Cohort 3, Phase 1) | 10.5 |
| RTD (Cohort 2, Phase 2) | 6.47 |
Complete Response(CR) and Very Good Partial Response(VGPR)
To determine the best overall response (CR+VGPR+PR) of the lenalidomide, thalidomide, dexamethasone combination based on IMWG criteria at nadir. (NCT00966693)
Timeframe: Evaluated each 28-day cycle and nadir of criteria is considered best overall response (median time to best response for this study was 2 cycles (range for best overall response was 1-21 cycles).
| Intervention | Participants (Count of Participants) |
|---|
| Partial Remission | Progressive Disease | Very Good Partial Remission | Minimal Residual Disease | Stringent Complete Remission | Non Evaluable | Stable Disease |
|---|
| RTD (Cohort 1, Phase 1) | 2 | 0 | 0 | 0 | 0 | 1 | 0 |
,| RTD (Cohort 2, Phase 1) | 0 | 2 | 3 | 0 | 0 | 0 | 0 |
,| RTD (Cohort 2, Phase 2) | 13 | 6 | 8 | 9 | 3 | 7 | 7 |
,| RTD (Cohort 3, Phase 1) | 2 | 2 | 1 | 1 | 0 | 3 | 0 |
Time to Progression
Time to Progression was estimated using Kaplan Meier analysis. (NCT00966693)
Timeframe: Up to 9 years
| Intervention | Months (Mean) |
|---|
| RTD (Cohort 1, Phase 1) | 32.74 |
| RTD (Cohort 2, Phase 1) | 9.04 |
| RTD (Cohort 3, Phase 1) | 14.61 |
| RTD (Cohort 2, Phase 2) | 10.02 |
Major Perioperative Morbidity
Our primary outcome was a collapsed composite endpoint (any versus none) defined as the occurrence of at least one of sixteen major complications before hospital discharge, including sepsis, severe surgical site infection, myocardial infarction, heart failure, stroke, unstable ventricular arrhythmias, pulmonary embolism, pneumonia, respiratory failure, dialysis dependent renal failure, large pleural or peritoneal effusions, major bleeding, major wound and surgical site healing complications, vascular graft thrombosis, and 30-day mortality. (NCT00995501)
Timeframe: 30 day after surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intensive Glucose Control, Dexamethasone, Light Anesthesia | 10 |
| Intensive Glucose Control, Dexamethasone, Deep Anesthesia | 10 |
| Intensive Glucose Control, Placebo, Light Anesthesia | 8 |
| Conventional Glucose Control, Dexamethasone, Light Anesthesia | 9 |
| Intensive Glucose Control, Placebo, Deep Anesthesia | 10 |
| Conventional Glucose Control, Dexamethasone, Deep Anesthesia | 8 |
| Conventional Glucose Control, Placebo, Light Anesthesia | 11 |
| Conventional Glucose Control, Placebo, Deep Anesthesia | 9 |
1 Year Mortality
All-cause mortality (NCT00995501)
Timeframe: 1 year after surgery
| Intervention | Participants (Count of Participants) |
|---|
| Intensive Glucose Control, Dexamethasone, Light Anesthesia | 1 |
| Intensive Glucose Control, Dexamethasone, Deep Anesthesia | 7 |
| Intensive Glucose Control, Placebo, Light Anesthesia | 9 |
| Conventional Glucose Control, Dexamethasone, Light Anesthesia | 7 |
| Intensive Glucose Control, Placebo, Deep Anesthesia | 7 |
| Conventional Glucose Control, Dexamethasone, Deep Anesthesia | 7 |
| Conventional Glucose Control, Placebo, Light Anesthesia | 5 |
| Conventional Glucose Control, Placebo, Deep Anesthesia | 2 |
The Percentage of Patients Alive Without Progression
"The Progression Free Survival (PFS) rate will be determined at 12 and 24 months post treatment.~Progressive Disease (PD) is defined as an increase of greater than or equal to 25% from lowest response level in serum M-component and/ or urine M-component and/ or the difference between involved or uninvolved SFLC levels and/ or bone marrow % plasma cells. PD may also be the development of new bone lesions or soft tissue plasmacytomas or the increase in size of existing lesions. PD may also be the development of hypercalcemia." (NCT01029054)
Timeframe: 12 Months and 24 Months Post Treatment
| Intervention | percentage of patients (Number) |
|---|
| Percentage of Patients Without Progression at 12 m | Percentage of Patients Without Progression at 24 m |
|---|
| Carfilzomib, Lenalidomide w/Dexamethasone | 97 | 92 |
The Maximum Tolerated Dose (MTD) of Carfilzomib
Determine the MTD of Carfilzomib when combined with Lenalidomide and Dexamethasone. The estimated time to determine the MTD is 6 months. (NCT01029054)
Timeframe: 6 Months
| Intervention | mg/m^2 (Number) |
|---|
| Carfilzomib, Lenalidomide w/Dexamethasone | 36 |
The Percentage of Patients That Achieve a Response to Treatment
"The percentage of patients that achieve at least a sCR (Stringent Complete Response), at least a VGPR (Very Good Partial Response) and at least a PR (Partial Response) will be determined.~sCR is defined as:~Negative immunofixation on the serum and urine and~Disappearance of any soft tissue plasmacytomas and~< 5% plasma cells in bone marrow and~Normal SFLC ratio and~Absence of clonal cells in bone marrow~VGPR is defined as:~Serum and urine M-protein detectable by immunofixation but not on electrophoresis or~≥ 90% reduction in serum M-component with urine M-component < 100 mg per 24 hours~PR is defined as:~≥ 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hours~If present at baseline, a ≥ 50% reduction in the size of soft tissue plasmacytomas is also required" (NCT01029054)
Timeframe: 4 Months After Treatment Start
| Intervention | percentage of patients (Number) |
|---|
| % of patients that achieve at least a sCR | % of patients that achieve at least a VGPR | % of patients that achieve at least a PR |
|---|
| Carfilzomib, Lenalidomide w/Dexamethasone | 42 | 81 | 98 |
Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) at Baseline
(NCT01033825)
Timeframe: Baseline
| Intervention | mcg•h/dL (Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 83.4 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 76.2 |
| HFA Nasal Aerosol Placebo | 81.1 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 80.9 |
| AQ Nasal Spray Placebo | 81.8 |
The Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) From Baseline to Week 6 of the Double Blind Treatment Period
Change is calculated as week 6 minus baseline. AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE). (NCT01033825)
Timeframe: week 6
| Intervention | mcg•h/dL (Least Squares Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | -4.6 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | -2.6 |
| HFA Nasal Aerosol Placebo | -5.0 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | -11.4 |
| Placebo Aqueous Nasal Spray | -1.0 |
Time to Maximal Effect Over 6 Weeks of Double-blind Treatment.
The time to maximal effect is defined as the number of days until the first treatment day on which the estimated difference between each active treatment group and corresponding placebo is at least 90% of the largest estimated difference. This is based on the analyses of change from baseline in the average of AM and PM reflective TNSS scores for each day. The evaluation is made separately for each dose level of Ciclesonide HFA compared to placebo. Difference is calculated as placebo - ciclesonide. Analysis of HFA data and AQ data were conducted separately. (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | Number of days (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 15 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 29 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 7 |
Baseline Daily Subject-reported Individual AM and PM Reflective NSS
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Baseline Nasal Sneezing | Baseline Runny Nose | Baseline Nasal Itching | Baseline Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | 1.66 | 2.11 | 1.96 | 2.27 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | 1.51 | 2.29 | 1.89 | 2.33 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | 1.76 | 2.18 | 1.95 | 2.31 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | 1.69 | 2.01 | 1.73 | 2.26 |
,| HFA Nasal Aerosol Placebo | 1.62 | 2.13 | 1.82 | 2.26 |
Baseline Daily Subject-reported Individual AM Instantaneous NSS
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Baseline Nasal Sneezing | Baseline Runny Nose | Baseline Nasal Itching | Baseline Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | 1.30 | 1.93 | 1.76 | 2.20 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | 1.15 | 2.08 | 1.76 | 2.25 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | 1.43 | 2.08 | 1.85 | 2.27 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | 1.24 | 1.83 | 1.61 | 2.24 |
,| HFA Nasal Aerosol Placebo | 1.34 | 2.01 | 1.76 | 2.27 |
Baseline Daily Subject-reported Individual PM Instantaneous NSS
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Baseline Nasal Sneezing | Baseline Runny Nose | Baseline Nasal Itching | Baseline Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | 1.47 | 2.01 | 1.84 | 2.12 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | 1.30 | 2.13 | 1.79 | 2.16 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | 1.51 | 2.03 | 1.88 | 2.19 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | 1.42 | 1.80 | 1.60 | 2.02 |
,| HFA Nasal Aerosol Placebo | 1.40 | 1.98 | 1.64 | 2.11 |
Baseline Daily Subject-reported AM and PM Reflective TNSS
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 7.68 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 8.20 |
| HFA Nasal Aerosol Placebo | 7.82 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 8.01 |
| AQ Nasal Spray Placebo | 8.01 |
Baseline Daily Subject-reported AM and PM Instantaneous TNSS
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 6.87 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 7.62 |
| HFA Nasal Aerosol Placebo | 7.26 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 7.30 |
| AQ Nasal Spray Placebo | 7.33 |
Number of Subjects Experiencing Adverse Events (AEs)
(NCT01033825)
Timeframe: Weeks 0-6
| Intervention | participants (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 23 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 17 |
| HFA Nasal Aerosol Placebo | 23 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 19 |
| Placebo Aqueous Nasal Spray | 29 |
Baseline Daily Subject-reported Individual AM and PM Instantaneous NSS
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Baseline Nasal Sneezing | Baseline Runny Nose | Baseline Nasal Itching | Baseline Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | 1.38 | 1.98 | 1.80 | 2.16 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | 1.22 | 2.10 | 1.78 | 2.20 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | 1.47 | 2.05 | 1.87 | 2.23 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | 1.33 | 1.81 | 1.61 | 2.13 |
,| HFA Nasal Aerosol Placebo | 1.37 | 2.00 | 1.70 | 2.19 |
Change From Baseline in Daily Subject-reported AM and PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | -1.45 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | -1.67 |
| HFA Nasal Aerosol Placebo | -0.19 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | -1.15 |
| AQ Nasal Spray Placebo | -0.75 |
Change From Baseline in Daily Subject-reported AM and PM Reflective TNSS Averaged Over Each Week, and Averaged Over the 6 Weeks of Double-blind Treatment
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | -1.78 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | -1.82 |
| HFA Nasal Aerosol Placebo | -0.33 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | -1.16 |
| AQ Nasal Spray Placebo | -1.06 |
Baseline Daily Subject-reported Individual AM Reflective NSS
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Baseline Nasal Sneezing | Baseline Runny Nose | Baseline Nasal Itching | Baseline Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | 1.57 | 2.06 | 1.92 | 2.29 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | 1.42 | 2.27 | 1.85 | 2.36 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | 1.65 | 2.16 | 1.89 | 2.32 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | 1.56 | 1.99 | 1.71 | 2.30 |
,| HFA Nasal Aerosol Placebo | 1.54 | 2.15 | 1.83 | 2.29 |
Percentage of Subjects Experiencing Adverse Events (AEs)
(NCT01033825)
Timeframe: Weeks 0-6
| Intervention | percentage of subjects (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 45.1 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 28.3 |
| HFA Nasal Aerosol Placebo | 30.7 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 39.6 |
| AQ Nasal Spray Placebo | 38.2 |
Ratio (Percentage) of Correct Advances of the Dose Indicator Out of Expected Advances.
Ratio of correct advance is defined as the (number of doses actuated/number of dose reported). (NCT01033825)
Timeframe: Weeks 1-2, 2-4
| Intervention | percentage of correct advances (Mean) |
|---|
| Weeks 1-2 (n=49,58,75) | Weeks 2-4 (n=46,52,71) |
|---|
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 106.2 | 105.9 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | 106.3 | 105.6 |
,| HFA Nasal Aerosol Placebo | 105.3 | 105.8 |
Change From Baseline in Daily Subject-reported Individual PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Nasal Sneezing | Runny Nose | Nasal Itching | Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | -0.27 | -0.37 | -0.34 | -0.21 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | -0.23 | -0.37 | -0.32 | -0.20 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | -0.48 | -0.48 | -0.46 | -0.44 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | -0.45 | -0.49 | -0.38 | -0.44 |
,| HFA Nasal Aerosol Placebo | -0.13 | -0.09 | -0.05 | -0.04 |
Change From Baseline in Daily Subject-reported Individual PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Nasal Sneezing | Runny Nose | Nasal Itching | Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | -0.22 | -0.30 | -0.25 | -0.12 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | -0.24 | -0.33 | -0.35 | -0.15 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | -0.37 | -0.45 | -0.44 | -0.39 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | -0.33 | -0.41 | -0.32 | -0.34 |
,| HFA Nasal Aerosol Placebo | -0.07 | -0.08 | 0.02 | 0.02 |
Percentage of Subjects Experiencing Local Nasal AEs
Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions. (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | percentage of subjects (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 41.2 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 18.3 |
| HFA Nasal Aerosol Placebo | 14.0 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 33.3 |
| AQ Nasal Spray Placebo | 19.0 |
| Placebo HFA Plus 6 mg Dexamethasone | 27.8 |
| Placebo AQ Plus 6 mg Dexamethasone | 5.6 |
Percentage of Subjects Experiencing Serious Adverse Events (SAEs).
(NCT01033825)
Timeframe: Weeks 0-6
| Intervention | percentage of subjects (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 0 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 0 |
| HFA Nasal Aerosol Placebo | 0 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 0 |
| AQ Nasal Spray Placebo | 0 |
Percentage of Subjects Who Discontinue Due to AEs
(NCT01033825)
Timeframe: Weeks 0-6
| Intervention | percentage of subjects (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 0 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 0 |
| HFA Nasal Aerosol Placebo | 0 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 2.1 |
| AQ Nasal Spray Placebo | 0 |
Change From Baseline in Daily Subject-reported AM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | -1.52 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | -1.62 |
| HFA Nasal Aerosol Placebo | -0.26 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | -1.23 |
| AQ Nasal Spray Placebo | -0.60 |
Change From Baseline in Daily Subject-reported AM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | -1.80 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | -1.75 |
| HFA Nasal Aerosol Placebo | -0.35 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | -1.18 |
| AQ Nasal Spray Placebo | -0.91 |
Percentage of Devices With Actuation Consistency
Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration. (NCT01033825)
Timeframe: Weeks 1-4
| Intervention | percentage of devices (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 91.3 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 92.3 |
| HFA Nasal Aerosol Placebo | 95.8 |
Change From Baseline in Daily Subject-reported PM Instantaneous TNSS Averaged Over the 6 Weeks of Double-blind Treatment
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | -1.39 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | -1.67 |
| HFA Nasal Aerosol Placebo | -0.10 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | -1.09 |
| AQ Nasal Spray Placebo | -0.88 |
Change From Baseline in Daily Subject-reported PM Reflective TNSS Averaged Over the 6 Weeks of Double-blind Treatment
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | -1.77 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | -1.88 |
| HFA Nasal Aerosol Placebo | -0.31 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | -1.14 |
| AQ Nasal Spray Placebo | -1.19 |
Change From Baseline in Daily Subject-reported Individual AM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Nasal Sneezing | Runny Nose | Nasal Itching | Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | -0.25 | -0.29 | -0.25 | -0.13 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | -0.28 | -0.36 | -0.33 | -0.20 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | -0.41 | -0.50 | -0.40 | -0.42 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | -0.41 | -0.50 | -0.40 | -0.49 |
,| HFA Nasal Aerosol Placebo | -0.09 | -0.17 | -0.05 | -0.05 |
Change From Baseline in Daily Subject-reported Individual AM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Nasal Sneezing | Runny Nose | Nasal Itching | Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | -0.17 | -0.23 | -0.14 | -0.06 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | -0.24 | -0.36 | -0.40 | -0.20 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | -0.37 | -0.47 | -0.40 | -0.37 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | -0.32 | -0.43 | -0.38 | -0.41 |
,| HFA Nasal Aerosol Placebo | -0.06 | -0.12 | -0.03 | -0.05 |
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) From Baseline After 6 Weeks of Treatment
(NCT01033825)
Timeframe: Weeks 0-6
| Intervention | mcg•h/dL (Least Squares Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | -1.0 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | -1.3 |
| HFA Nasal Aerosol Placebo | 0.5 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | -5.8 |
| AQ Nasal Spray Placebo | -2.9 |
Change in Serum Cortisol Area Under the Concentration-time Curve (AUC)(12-24h) From Baseline After 6 Weeks of Treatment
(NCT01033825)
Timeframe: Weeks 0-6
| Intervention | mcg•h/dL (Least Squares Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | -3.9 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | -2.0 |
| HFA Nasal Aerosol Placebo | -5.9 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | -6.1 |
| AQ Nasal Spray Placebo | 2.2 |
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-12h) at Baseline
(NCT01033825)
Timeframe: Baseline
| Intervention | mcg•h/dL (Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 99.8 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 95.1 |
| HFA Nasal Aerosol Placebo | 92.0 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 91.9 |
| AQ Nasal Spray Placebo | 97.2 |
Change From Baseline in Daily Subject-reported Individual AM and PM Reflective NSS Averaged Over the 6 Weeks of Double-blind Treatment Period
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Nasal Sneezing | Runny Nose | Nasal Itching | Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | -0.26 | -0.33 | -0.30 | -0.17 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | -0.25 | -0.37 | -0.32 | -0.20 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | -0.45 | -0.50 | -0.43 | -0.43 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | -0.43 | -0.50 | -0.39 | -0.47 |
,| HFA Nasal Aerosol Placebo | -0.11 | -0.13 | -0.05 | -0.04 |
Change From Baseline in Daily Subject-reported Individual AM and PM Instantaneous NSS Averaged Over the 6 Weeks of Double-blind Treatment
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Instantaneous NSS measures these symptoms over the previous 10 minute time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | units on a scale (Least Squares Mean) |
|---|
| Nasal Sneezing | Runny Nose | Nasal Itching | Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | -0.20 | -0.27 | -0.20 | -0.09 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | -0.23 | -0.35 | -0.37 | -0.17 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | -0.37 | -0.47 | -0.42 | -0.39 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | -0.32 | -0.42 | -0.35 | -0.37 |
,| HFA Nasal Aerosol Placebo | -0.06 | -0.10 | -0.01 | -0.01 |
Baseline Daily Subject-reported Individual PM Reflective NSS
"NSS is the assessment of the individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptoms on a scale of 0-3 where: 0 = absent (no sign/symptom evident);~= mild~= moderate~= severe Reflective NSS measures these symptoms over the previous 12-hour time interval. Difference was calculated by subtracting baseline value from the 6-week DB average. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Baseline Nasal Sneezing | Baseline Runny Nose | Baseline Nasal Itching | Baseline Nasal Congestion |
|---|
| AQ Nasal Spray Placebo | 1.74 | 2.16 | 2.00 | 2.25 |
,| Ciclesonide Aqueous Nasal Spray 200 Mcg | 1.59 | 2.30 | 1.93 | 2.31 |
,| Ciclesonide HFA Nasal Aerosol 160 Mcg | 1.87 | 2.20 | 2.02 | 2.30 |
,| Ciclesonide HFA Nasal Aerosol 320 Mcg | 1.82 | 2.03 | 1.75 | 2.23 |
,| HFA Nasal Aerosol Placebo | 1.69 | 2.11 | 1.80 | 2.23 |
Baseline Daily Subject-reported AM Instantaneous TNSS
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 6.91 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 7.63 |
| HFA Nasal Aerosol Placebo | 7.37 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 7.24 |
| AQ Nasal Spray Placebo | 7.19 |
Baseline Daily Subject-reported AM Reflective TNSS
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 7.55 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 8.03 |
| HFA Nasal Aerosol Placebo | 7.81 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 7.91 |
| AQ Nasal Spray Placebo | 7.84 |
Baseline Daily Subject-reported PM Instantaneous TNSS
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, iTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Instantaneous TNSS measures these symptoms over the previous 10 minute time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 6.84 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 7.60 |
| HFA Nasal Aerosol Placebo | 7.13 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 7.38 |
| AQ Nasal Spray Placebo | 7.44 |
Baseline Daily Subject-reported PM Reflective TNSS
"TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where:~0 = absent~= mild~= moderate~= severe Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval. Difference was calculated as the six week treatment average - baseline. Greater reductions in the change from baseline score indicate greater improvement." (NCT01033825)
Timeframe: Baseline
| Intervention | units on a scale (Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 7.82 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 8.39 |
| HFA Nasal Aerosol Placebo | 7.83 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 8.13 |
| AQ Nasal Spray Placebo | 8.16 |
Serum Cortisol Area Under the Concentration-time Curve (AUC)(0-24h) at Baseline
AUC(0-24h) will be computed using the linear trapezoidal rule based on the actual time of serum cortisol drawing. AUC(0-24) is then approximated by the sum of the areas of trapezoids. The trapezoid for each time interval is based on the actual times of non-missing cortisol values, and is defined by the actual time interval as the base, the line connecting the two cortisol values, and the two vertical sides at the two time points. Raw data is presented for baseline values (i.e. mean/SD), while inferential statistics are presented for week 6 values (i.e. LS mean/SE). (NCT01033825)
Timeframe: Baseline
| Intervention | mcg•h/dL (Mean) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 183.2 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 171.7 |
| HFA Nasal Aerosol Placebo | 173.1 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 172.8 |
| Placebo Aqueous Nasal Spray | 179.0 |
Number of Devices With Major Discrepancies
A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration. (NCT01033825)
Timeframe: Week 6
| Intervention | Devices (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 0 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 2 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 1 |
Number of Subjects Experiencing Local Nasal AEs
Local Nasal adverse events are defined as adverse events occurring in the middle ear, nose, throat, and upper respiratory tract down to the larynx, anatomic regions. (NCT01033825)
Timeframe: Weeks 0-6
| Intervention | participants (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 21 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 11 |
| HFA Nasal Aerosol Placebo | 8 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 16 |
| AQ Nasal Spray Placebo | 11 |
| Placebo HFA Plus 6 mg Dexamethasone | 5 |
| Placebo AQ Plus 6 mg Dexamethasone | 1 |
Number of Subjects Experiencing Serious Adverse Events (SAEs).
(NCT01033825)
Timeframe: Weeks 0-6
| Intervention | participants (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 0 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 0 |
| HFA Nasal Aerosol Placebo | 0 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 0 |
| AQ Nasal Spray Placebo | 0 |
Number of Subjects Who Discontinue Due to AEs
(NCT01033825)
Timeframe: Weeks 0-6
| Intervention | participants (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 0 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 0 |
| HFA Nasal Aerosol Placebo | 0 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 1 |
| AQ Nasal Spray Placebo | 0 |
Percentage of Devices With Major Discrepancies
A major discrepancy is defined as a discrepancy of >20 actuations between the dose indicator and subject self report of study medication administration. (NCT01033825)
Timeframe: Week 6
| Intervention | percentage of devices (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 0 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 3.8 |
| HFA Nasal Aerosol Placebo | 1.4 |
Number of Devices With Actuation Consistency
Actuation consistency is defined as a dose indicator count within ±20% of the subject self report of study medication administration. (NCT01033825)
Timeframe: Weeks 1-4
| Intervention | Devices (Number) |
|---|
| Ciclesonide HFA Nasal Aerosol 320 Mcg | 42 |
| Ciclesonide HFA Nasal Aerosol 160 Mcg | 48 |
| Ciclesonide Aqueous Nasal Spray 200 Mcg | 68 |
Number of Participants Who Achieved a Second Decline in Prostate Specific Antigen (PSA) Following Progression on First Regimen
The number of participants who experience a ≥30% decline in PSA between the time of first progression on ketoconazole and hydrocortisone and eight weeks after dexamethasone therapy was initiated. (NCT01036594)
Timeframe: Up to 5 years
| Intervention | Participants (Count of Participants) |
|---|
| Ketoconazole + Dexamethasone | 0 |
Subjects Assessment of Sore Throat Pain at 24 Hours
The reported score for sore throat on a 1 to 5 scale where 1 is a severe sore throat and 5 is no sore throat. This evaluation was made by investigator initiated phone conversation at 24 hours following surgery. (NCT01052038)
Timeframe: 24 hours
| Intervention | units on a scale (1 to 5) (Median) |
|---|
| Group 1 Placebo | 4 |
| Group 2: Dexamethasone 0.05mg/kg | 4 |
| Group 3:Dexamethasone 0.1mg/kg | 5 |
Number of Subjects With Sore Throat at 3 Hours Post Surgery.
Subjects were asked at 3 hours post surgery if they were experiencing a sore throat. (NCT01052038)
Timeframe: 3 hours.
| Intervention | participants (Number) |
|---|
| Group 1 Placebo | 24 |
| Group 2: Dexamethasone 0.05mg/kg | 17 |
| Group 3:Dexamethasone 0.1mg/kg | 10 |
Hoarseness at 24 Hours
Self assessment of the degree of hoarseness 24 hours after surgery and intratracheal intubation on a 1 to 1 Likert scale. 0 = no hoarseness and 3= hoarseness easily noted at time of interview. (NCT01052038)
Timeframe: 24 hours
| Intervention | participants (Number) |
|---|
| No hoarseness | No hoarseness at interview but present during 24h | Hoarseness at interview noted by patient | Hoarseness easily noted by interviewer |
|---|
| Group 1 Placebo | 5 | 10 | 15 | 6 |
,| Group 2: Dexamethasone 0.05mg/kg | 11 | 6 | 11 | 6 |
,| Group 3:Dexamethasone 0.1mg/kg | 18 | 8 | 6 | 4 |
Quality of Recovery at 24 Hours
The quality of recovery (QoR-40) questionnaire assess the subjects perceived quality of recovery following surgery. The tool assess pain, physical and psychological well being as well as ability to ability for self-care. Questions are scored on a 1 to 5 point scale with a higher value indication a better outcome. The scores or the individual questions are summed to obtain a total score. The minimum total score is 30 and the maximum is 200. The higher the score the better the recovery (NCT01052038)
Timeframe: 24 hours
| Intervention | units on a scale (30 to 200) higher scod (Median) |
|---|
| Group 1 Placebo | 171 |
| Group 2: Dexamethasone 0.05mg/kg | 179 |
| Group 3:Dexamethasone 0.1mg/kg | 193 |
Opioid Consumption at 24 Hours
The cumulative use of an opioid analgesic pain medication taken during the first 24 hours for pain and discomfort. Data reported as equivalent dose of oral morphine. (NCT01052038)
Timeframe: 24 hours
| Intervention | mg of oral morphine equivalents (Median) |
|---|
| Group 1 Placebo | 20 |
| Group 2: Dexamethasone 0.05mg/kg | 20 |
| Group 3:Dexamethasone 0.1mg/kg | 10 |
PK Assessment: Phase 1: Maximum Observed Plasma Concentration (Cmax) of Isatuximab
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population. (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
| Intervention | mcg/mL (Geometric Mean) |
|---|
| Cycle 1 Day 1 |
|---|
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 154 |
,| Phase 1: Isatuximab 0.3 mg/kg Q2W | 2.00 |
,| Phase 1: Isatuximab 1 mg/kg Q2W | 12.4 |
,| Phase 1: Isatuximab 20mg/kg Q2W | 457 |
,| Phase 1: Isatuximab 3mg/kg Q2W | 53.7 |
,| Phase 1: Isatuximab 5mg/kg Q2W | 126 |
,| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 181 |
PK Assessment: Phase 1: Maximum Observed Plasma Concentration (Cmax) of Isatuximab
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population. (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
| Intervention | mcg/mL (Geometric Mean) |
|---|
| Cycle 1 Day 1 | Cycle 3 Day 1 |
|---|
| Phase 1: Isatuximab 10mg/kg QW | 181 | 265 |
,| Phase 1: Isatuximab 20mg/kg QW | 343 | 712 |
PK Assessment: Phase 1: Plasma Concentration of Isatuximab at Week 1, 2 and 3
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). (NCT01084252)
Timeframe: Week 1, 2 and 3
| Intervention | mcg/mL (Geometric Mean) |
|---|
| Week 1 | Week 2 | Week 3 |
|---|
| Phase 1: 5mg/kg Q2W | 15.3 | 1.39 | 42.7 |
,| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 44.2 | 8.31 | 18.6 |
,| Phase 1: Isatuximab 1 mg/kg Q2W | 0.00223 | 0.000800 | 0.000283 |
,| Phase 1: Isatuximab 10 mg/kg QW | 20.7 | 55.1 | 75.9 |
,| Phase 1: Isatuximab 20mg/kg Q2W | 113 | 63.9 | 91.0 |
,| Phase 1: Isatuximab 20mg/kg QW | 108 | 194.8 | 347.3 |
,| Phase 1: Isatuximab 3mg/kg Q2W | 1.44 | 0.181 | 0.460 |
,| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 27.6 | 1.97 | 4.18 |
PK Assessment: Phase 1: Time to Reach Maximum Plasma Concentration Observed (Tmax) of Isatuximab
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population. (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
| Intervention | hours (Median) |
|---|
| Cycle 1 Day 1 |
|---|
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 4.92 |
,| Phase 1: Isatuximab 0.3 mg/kg Q2W | 2.49 |
,| Phase 1: Isatuximab 1 mg/kg Q2W | 4.35 |
,| Phase 1: Isatuximab 5mg/kg Q2W | 7.65 |
,| Phase 1: Isatuximab 20mg/kg Q2W | 5.87 |
,| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 4.28 |
,| Phase 1: Isatuximab 3mg/kg Q2W | 6.99 |
PK Assessment: Phase 1: Time to Reach Maximum Plasma Concentration Observed (Tmax) of Isatuximab
Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population. (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
| Intervention | hours (Median) |
|---|
| Cycle 1 Day 1 | Cycle 3 Day 1 |
|---|
| Phase 1: Isatuximab 10mg/kg QW | 2.25 | 4.30 |
,| Phase 1: Isatuximab 20mg/kg QW | 6.83 | 8.07 |
Clinical Assessment: Phase 1: Duration of Response (DOR)
DOR: time from first response (PR or better) to first documented tumor progression/death. Progression as per EBMT: >25% increase in serum monoclonal paraprotein level, which must also be an absolute increase of >= 5 g/l: confirmed by >=1 repeated investigation; >25% increase in 24h urinary light chain excretion, which must also be an absolute increase of >=200 mg/24 h:confirmed by >=1 repeated investigation; >25% increase in plasma cells in a bone marrow aspirate/on trephine biopsy, which must also be an absolute increase of >= 10%; definite increase in size of existing bone lesions/soft tissue plasmacytomas; development of new bone lesions/soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11·5 mg/dl or 2·8 mmol/l) not attributable to any other cause. PR: >=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size/number of lytic bone lesions. (NCT01084252)
Timeframe: From the date of first response to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)
| Intervention | months (Mean) |
|---|
| Phase 1: Isatuximab 1mg/kg Q2W | 20.21 |
| Phase 1: Isatuximab 5mg/kg Q2W | 7.16 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 5.76 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 10.70 |
| Phase 1: Isatuximab 10mg/kg QW | 14.31 |
| Phase 1: Isatuximab 20mg/kg Q2W | 3.94 |
| Phase 1: Isatuximab 20mg/kg QW | 8.82 |
Clinical Assessment: Phase 1: Time to First Response (TTR)
TTR was defined as the time from first dose of isatuximab to first response (PR or better). PR: >=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions. (NCT01084252)
Timeframe: From the date of first dose administration to the date of first response or death (due to any cause) (maximum duration: 120 weeks)
| Intervention | months (Mean) |
|---|
| Phase 1: Isatuximab 1mg/kg Q2W | 0.95 |
| Phase 1: Isatuximab 5mg/kg Q2W | 6.41 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 2.52 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 1.96 |
| Phase 1: Isatuximab 10mg/kg QW | 1.38 |
| Phase 1: Isatuximab 20mg/kg Q2W | 1.18 |
| Phase 1: Isatuximab 20mg/kg QW | 1.46 |
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 1 Week Interval
(NCT01084252)
Timeframe: Pre-dose, at the end of infusion, 1 hour and 168 hours post dose on Day 1 of Cycle 1
| Intervention | mcg*hour/mL (Geometric Mean) |
|---|
| Phase 2 Stage 2: Isatuximab Alone | 37096 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 35423 |
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 2 Weeks Interval
(NCT01084252)
Timeframe: Cycle 1, Day 1: pre-dose, at the end of infusion, 168 and 336 hours post-infusion
| Intervention | mcg*hour/mL (Geometric Mean) |
|---|
| Phase 2 Stage 2: Isatuximab Alone | 91271 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 86761 |
Pharmacokinetic Assessment: Phase 2 Stage 2: Area Under the Plasma Concentration Versus Time Curve of Isatuximab Over 4 Weeks Interval
(NCT01084252)
Timeframe: Cycle 1, Day 1: pre-dose, at the end of infusion, 168, 336, and 672 hours post-infusion
| Intervention | mcg*hour/mL (Geometric Mean) |
|---|
| Phase 2 Stage 2: Isatuximab Alone | 236360 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 226372 |
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
DLTs were assessed using the national cancer institute common terminology criteria for adverse events (NCI-CTCAE) version 4.03. DLTs were defined as any Grade 3 or higher non-hematological toxicity (with the exception of allergic reaction/hypersensitivity), Grade 4 neutropenia and/or Grade 4 thrombocytopenia lasting longer than 5 days, attributed to isatuximab. Any other toxicity that the Investigator and the Sponsor deemed to be dose-limiting, regardless of the grade, was also considered as DLT. (NCT01084252)
Timeframe: Day 1 of Cycle 1 up to Day 14 of Cycle 2
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1:Isatuximab <=1 mg/kg Q2W | 1 |
| Phase 1: Isatuximab 3mg/kg Q2W | 1 |
| Phase 1: Isatuximab 5mg/kg Q2W | 0 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 0 |
| Phase 1: Isatuximab 10 mg/kg QW | 0 |
| Phase 1: Isatuximab 20mg/kg Q2W | 0 |
| Phase 1: Isatuximab 20mg/kg QW | 0 |
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment. (NCT01084252)
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 120 weeks )
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1: Isatuximab <=1mg/kg Q2W | 16 |
| Phase 1: Isatuximab 3mg/kg Q2W | 6 |
| Phase 1: Isatuximab 5mg/kg Q2W | 3 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 26 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 18 |
| Phase 1: Isatuximab 10 mg/kg QW | 6 |
| Phase 1: Isatuximab 20mg/kg Q2W | 7 |
| Phase 1: Isatuximab 20mg/kg QW | 6 |
Phase 2 Stage 1: Duration of Response
DOR:Time from date of 1st IAC determined response (>= PR) that was subsequently confirmed, to date of first IAC determined PD/death, whichever happened earlier. updated IMWG criteria- PR:>=50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or a >=50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline a >=50% reduction in size of soft tissue plasmacytomas; PD: Increase of 25% from lowest response value in any of following: Serum M-protein >=0.5 g/dL absolute increase and/or urine M-protein >=200 mg/24 hours absolute increase and/or >10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, >=10% bone marrow plasma cells (PCs), development of new bone lesions/soft tissue plasmacytomas or definite increase in size of existing bone lesions/soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium >11·5 mg/dl) attributed to PC proliferation disorder. (NCT01084252)
Timeframe: From the date of first response until disease progression or death or data cut-off (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | months (Mean) |
|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 1.91 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 11.17 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | 7.31 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 8.11 |
Phase 2 Stage 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment. (NCT01084252)
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | Participants (Count of Participants) |
|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 22 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 24 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | 25 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 25 |
Phase 2 Stage 1: Overall Survival (OS)
OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method. (NCT01084252)
Timeframe: From the date of randomization to date of death from any cause (maximum duration 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | months (Median) |
|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 15.277 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 18.628 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | NA |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | NA |
Phase 2 Stage 1: Percentage of Participants With Clinical Benefit
Clinical benefit: participants with sCR, CR, VGPR, PR or MR as per IMWG criteria, determined by IAC. CR: negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytomas,<5% PCs in bone marrow aspirates. sCR: CR + normal FLC ratio (0.26-1.65), absence of clonal cells in bone marrow biopsy. VGPR: serum & urine M-component detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-component plus urine M-component level <100mg/24hours; PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours, ≥50% decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria or a ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline, ≥50% size reduction in soft tissue plasmacytomas. MR:>=25 but <49% reduction in serum M-protein, reduction in 24h urine M-protein by 50-89%, 25-49% size reduction in soft tissue plasmacytomas. (NCT01084252)
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 4.3 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 41.7 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | 32.0 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 36.0 |
Phase 2 Stage 1: Progression Free Survival (PFS)
PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression (PD) or date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of > 25% from lowest response value in any one or more of the following: Serum M-component and/or (the absolute increase must be > 0.5 g/dL), Urine M-component and/or (the absolute increase must be > 200 mg/24 h), > 10mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, >10% absolute percentage of bone marrow plasma cell, definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas, development of hypercalcemia (corrected serum calcium > 11.5 mg/dL or 2.65 mmol/L) that attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method. (NCT01084252)
Timeframe: From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | months (Median) |
|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 2.1 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 9.6 |
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | 4.4 |
| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 3.6 |
Phase 2 Stage 2: Duration of Response
DOR: Time from date of 1st IAC determined response (>= PR) that was subsequently confirmed, to date of 1st IAC determined PD or death, whichever happened earlier. As per updated IMWG criteria-PR: ≥50% reduction of serum M-Protein and reduction in urinary M-protein by ≥90% or to <200 mg/24 hours. ≥50% decrease in difference between involved and uninvolved FLC levels in place of M-protein criteria or ≥50% reduction in plasma cells in place of M-protein if baseline was ≥30%. If present at baseline ≥50% reduction in size of soft tissue plasmacytomas; PD: Increase of >25% from lowest response value in any one of following: Serum M-component (absolute increase must be >0.5 g/dL)4 and/or Urine M-component (absolute increase must be >200 mg/24 h) and/or >10 mg/dL absolute increase in difference between involved and uninvolved FLC levels, >=10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to plasma cell proliferative disorder. (NCT01084252)
Timeframe: From the date of first response until disease progression or death or data cut-off (maximum duration: 97 weeks)
| Intervention | months (Mean) |
|---|
| Phase 2 Stage 2: Isatuximab Alone | 8.6 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 10.9 |
Phase 2 Stage 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. TEAEs were defined as AEs that developed or worsened during the on-treatment period which was defined as the period from the time of first dose of study treatment until 30 days after the last dose of study treatment. (NCT01084252)
Timeframe: From Baseline up to 30 days after the last dose (maximum duration: 97 weeks)
| Intervention | Participants (Count of Participants) |
|---|
| Phase 2 Stage 2: Isatuximab Alone | 100 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 51 |
Phase 2 Stage 2: Overall Survival
OS was defined as the time interval from the date of first Isatuximab administration to death from any cause. Analysis was performed by Kaplan-Meier method. (NCT01084252)
Timeframe: From the date of randomization to date of death from any cause (maximum duration: 97 weeks)
| Intervention | months (Median) |
|---|
| Phase 2 Stage 2: Isatuximab Alone | 18.92 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 17.25 |
Phase 2 Stage 2: Percentage of Participants With Clinical Benefit
Clinical benefit:participants with sCR, CR, VGPR, PR or MR, per IMWG criteria, determined by IAC. CR:negative immunofixation on serum & urine, disappearance of any soft tissue plasmacytomas,<5% plasma cells in bone marrow aspirates,normal FLC ratio(0.26-1.65) in participants with only FLC disease.sCR:CR+normal FLC ratio, absence of clonal cells in bone marrow biopsy.VGPR:serum & urine M-component detectable by immunofixation, not on electrophoresis/,>=90% reduction in serum M-component plus urine M-component level <100mg/24h/,>=90% decrease in difference between involved and uninvolved FLC levels; PR:>=50% reduction of serum M-protein, reduction in 24h urinary M-protein by >=90%/<200mg/24h,>50% decrease in difference between involved and uninvolved FLC in place of M-protein criteria, >=50% reduction in size/number of soft tissue plasmacytomas. MR:>=25 but <49% reduction in serum M-protein,reduction in 24h urine M-protein by 50-89%, 25-49% reduction in size of soft tissue plasmacytomas (NCT01084252)
Timeframe: From the date of randomization to the date of first documentation of progression or death (maximum duration: 97 weeks )
| Intervention | percentage of participants (Number) |
|---|
| Phase 2 Stage 2: Isatuximab Alone | 43.1 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 54.5 |
Phase 2 Stage 2: Percentage of Participants With Overall Response According to Updated IMWG Response Criteria
OR: participants with sCR or CR or VGPR or PR. As per updated IMWG, CR: Negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas and <=5% plasma cells in bone marrow; normal FLC ratio of 0.26-1.65 in participants with only FLC disease; sCR: CR and normal FLC ratio and no clonal cells in bone marrow; VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >=90% reduction in serum M-protein and urine M-protein level <100 mg/24 hours, >90% decrease in the difference between involved and uninvolved FLC levels; PR: >=50% reduction of serum M-Protein and reduction in urinary M-protein by >=90% or to <200 mg/24 hours; >=50% decrease in the difference between involved and uninvolved FLC levels in place of M-protein criteria or >=50% reduction in plasma cells in place of M-protein if present at baseline. (NCT01084252)
Timeframe: From the date of randomization to date of death from any cause (maximum duration: 97 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Phase 2 Stage 2: Isatuximab Alone | 23.9 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 43.6 |
Phase 2 Stage 2: Progression Free Survival
PFS was defined as the time interval from the date of first isatuximab administration to the date of the first IAC-confirmed disease progression or the date of death due to any cause, whichever came first. As per IMWG criteria, PD: Increase of >25% from lowest response value in any one of the following: Serum M-component (the absolute increase must be >0.5 g/dL)4 and/or Urine M-component (the absolute increase must be >200 mg/24 h) and/or >10 mg/dL decrease in the difference between involved and uninvolved FLC levels in place of the M-protein criteria, ≥10% bone marrow plasma cell, development of hypercalcemia (corrected serum calcium >11.5 mg/dL) attributed solely to the plasma cell proliferative disorder. Analysis was performed by Kaplan-Meier method. (NCT01084252)
Timeframe: From the date of the first dose administration until progression or death, whichever occurred first (maximum duration: 97 weeks)
| Intervention | months (Median) |
|---|
| Phase 2 Stage 2: Isatuximab Alone | 4.86 |
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 10.15 |
PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First 2 Weeks (0-336 Hours) (AUC2W)
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 336 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 336 hr post-infusion
| Intervention | mcg*hour/mL (Geometric Mean) |
|---|
| Phase 1: Isatuximab 1 mg/kg Q2W | 222 |
| Phase 1: Isatuximab 3mg/kg Q2W | 3076 |
| Phase 1: Isatuximab 5mg/kg Q2W | 9546 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 14876 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 18967 |
| Phase 1: Isatuximab 10mg/kg QW | 30187 |
| Phase 1: Isatuximab 20mg/kg Q2W | 48003 |
| Phase 1: Isatuximab 20mg/kg QW | 71174 |
PK Assessment: Phase 1: Predicted Cumulative Area Under the Plasma Concentration Curve (AUC) of Isatuximab Over the First Week (0-168 Hours) (AUC1W)
Data for this outcome measure was planned to be collected and analyzed only for dose 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03, 0.1 and 0.3 mg/kg dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). (NCT01084252)
Timeframe: For Q2W:Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 3, 7, 24, 48 and 168 hr post-infusion; For QW: Cycle 1,Day 1: pre-dose, 15 min after start of infusion, at the end of infusion, 4, 24, 48, 72 and 168 hr post-infusion
| Intervention | mcg*hour/mL (Geometric Mean) |
|---|
| Phase 1: Isatuximab 1 mg/kg Q2W | 222 |
| Phase 1: Isatuximab 3mg/kg Q2W | 2624 |
| Phase 1: Isatuximab 5mg/kg Q2W | 7174 |
| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 11566 |
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 13480 |
| Phase 1: Isatuximab 10mg/kg QW | 12680 |
| Phase 1: Isatuximab 20mg/kg Q2W | 32739 |
| Phase 1: Isatuximab 20mg/kg QW | 28405 |
Clinical Assessment: Phase 1: Percentage of Participants With Overall Response and Clinical Benefit: Assessed Using European Society for Blood and Marrow Transplantation (EBMT) Criteria
OR defined as participants with complete response (CR) or partial response (PR) as best overall response (BOR). Clinical benefit: participants with minimal response (MR) or better as BOR. BOR: best sequential response from start of treatment through the entire study excluding any time point following start of other treatment. CR: negative immunofixation on serum and urine, disappearance of any soft tissue plasmacytomas, <5% plasma cells in bone marrow aspirates, no increase in size or number of lytic bone lesions. PR: >=50% reduction of serum M-protein, reduction in 24 h urinary M-protein by >=90% or <200mg, >=50% reduction in size/number of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions. MR: 25 to 49% reduction in serum M-protein, 50-89% reduction in 24h urine M-protein, 25-49% reduction in size of soft tissue plasmacytomas, no increase in size or number of lytic bone lesions. (NCT01084252)
Timeframe: From the date of randomization to the date of first documentation of progression or death (due to any cause) (maximum duration: 120 weeks)
| Intervention | percentage of participants (Number) |
|---|
| OR | Clinical benefit |
|---|
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 16.7 | 27.8 |
,| Phase 1: Isatuximab 10mg/kg QW | 33.3 | 33.3 |
,| Phase 1: Isatuximab 1mg/kg Q2W | 33.3 | 33.3 |
,| Phase 1: Isatuximab 20mg/kg Q2W | 14.3 | 28.6 |
,| Phase 1: Isatuximab 20mg/kg QW | 28.6 | 42.9 |
,| Phase 1: Isatuximab 3mg/kg Q2W | 0 | 20.0 |
,| Phase 1: Isatuximab 5mg/kg Q2W | 33.3 | 33.3 |
,| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 28.0 | 28.0 |
Immunogenicity Assessment: Phase 1: Number of Participants With Treatment-Emergent And Treatment-Boosted Anti-drug Antibodies (ADA) Response
ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 1) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment. (NCT01084252)
Timeframe: Up to 120 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Treatment-induced ADA | Treatment boosted ADA |
|---|
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 1 | 0 |
,| Phase 1: Isatuximab 10mg/kg QW | 1 | 0 |
,| Phase 1: Isatuximab 20mg/kg Q2W | 1 | 0 |
,| Phase 1: Isatuximab 20mg/kg QW | 1 | 0 |
,| Phase 1: Isatuximab 3mg/kg Q2W | 0 | 0 |
,| Phase 1: Isatuximab 5mg/kg Q2W | 0 | 0 |
,| Phase 1:Isatuximab <=1 mg/kg Q2W | 2 | 0 |
,| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 1 | 0 |
Immunogenicity Assessment: Phase 2 Stage 2: Number of Participants With Anti-drug Antibodies to Isatuximab
ADA response was categorized as: treatment induced and treatment boosted response. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period (defined as the time from the first isatuximab administration until end of Phase 2 Stage 2) in participants without preexisting ADA (defined as: ADA that were present in samples drawn before treatment), including participants without pre-treatment (before treatment) samples. Treatment boosted ADA was defined as pre-existing ADA that increased at least 2 titer steps between pre-treatment (before treatment) and post-treatment. (NCT01084252)
Timeframe: Up to 97 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Treatment induced ADA | Treatment boosted ADA |
|---|
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 0 | 0 |
,| Phase 2 Stage 2: Isatuximab Alone | 1 | 0 |
Pharmacodynamic (PD) Assessment: Phase 1: Change From Baseline in Serum/Plasma Markers
Serum/plasma markers included: tumor necrosis factor alpha (TNF-α), interleukin-1β (IL-1-β), interleukin 6 (IL-6) and interferon-gamma (IFN-Gamma). Due to change in planned analysis, data for high-sensitivity C-reactive protein (hs-CRP) and CD38 was not collected and analyzed. (NCT01084252)
Timeframe: Cycle 1 Day 1
| Intervention | picogram/milliliter (pg/mL) (Mean) |
|---|
| TNF alpha | IL-1 Beta | IL-6 | IFN Gamma |
|---|
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 503.462 | 547.770 | 173.004 | 568.806 |
,| Phase 1: Isatuximab 10mg/kg QW | 342.664 | 327.957 | -8.109 | 627.089 |
,| Phase 1: Isatuximab 20mg/kg Q2W | 307.319 | 305.914 | 274.616 | 448.387 |
,| Phase 1: Isatuximab 20mg/kg QW | 412.541 | 293.307 | 165.295 | 1487.097 |
,| Phase 1: Isatuximab 3mg/kg Q2W | 179.783 | 29.741 | 261.732 | 5.376 |
,| Phase 1: Isatuximab 5mg/kg Q2W | 352.974 | 7.527 | 73.899 | 25.806 |
,| Phase 1:Isatuximab <=1 mg/kg Q2W | 163.181 | 64.577 | 139.234 | 477.116 |
,| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 340.799 | 299.058 | 148.594 | 445.772 |
Pharmacokinetic (PK) Assessment: Phase 1: Plasma Concentration of Isatuximab Observed at the End of an Intravenous Infusion (Ceoi)
Ceoi was defined as the plasma concentration of Isatuximab at end of infusion. Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population: participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter. (NCT01084252)
Timeframe: Cycle 1 Day 1 and Cycle 3 Day 1: At the end of infusion
| Intervention | microgram per milliliter (mcg/mL) (Mean) |
|---|
| Cycle 1 Day 1 |
|---|
| Phase 1: Isatuximab (CD38 + HM and High Risk Multiple Myeloma) | 148.80000 |
,| Phase 1: Isatuximab 0.3 mg/kg Q2W | 2.08667 |
,| Phase 1: Isatuximab 1 mg/kg Q2W | 13.18333 |
,| Phase 1: Isatuximab 20mg/kg Q2W | 400.33333 |
,| Phase 1: Isatuximab 3mg/kg Q2W | 44.22500 |
,| Phase 1: Isatuximab 5mg/kg Q2W | 125.50000 |
,| Phase1:Isatuximab (CD38+HM and Standard Risk Multiple Myeloma) | 171.43333 |
Pharmacokinetic (PK) Assessment: Phase 1: Plasma Concentration of Isatuximab Observed at the End of an Intravenous Infusion (Ceoi)
Ceoi was defined as the plasma concentration of Isatuximab at end of infusion. Data for this outcome measure was planned to be collected and analyzed separately for dose 0.3 mg/kg, 1 mg/kg and not for 0.0001, 0.001, 0.01, 0.03 and 0.1 dose levels (reported under one arm, i.e. Phase 1: Isatuximab <=1mg/kg in participant flow). Analysis was performed on PK population: participants who gave informed consent, received at least one dose (even if incomplete) of isatuximab, had an assessable PK parameter. (NCT01084252)
Timeframe: Cycle 1 Day 1 and Cycle 3 Day 1: At the end of infusion
| Intervention | microgram per milliliter (mcg/mL) (Mean) |
|---|
| Cycle 1 Day 1 | Cycle 3 Day 1 |
|---|
| Phase 1: Isatuximab 10mg/kg QW | 173.33333 | 299.82500 |
,| Phase 1: Isatuximab 20mg/kg QW | 334.33333 | 715.33333 |
Pharmacokinetic Assessment: Phase 2 Stage 2: Accumulation Ratio of Isatuximab Based on Ctrough
Ctrough is the plasma concentration observed before treatment administration. For 1st category, the accumulation ratio was calculated by dividing Ctrough value of Cycle 2 Day 1 by Cycle 1 Day 8 and for second category, accumulation ratio was calculated by dividing Ctrough value of Cycle 4 Day 1 by Cycle 1 Day 8. (NCT01084252)
Timeframe: Cycle 2, Day 1; Cycle 1, Day 8; Cycle 4, Day 1
| Intervention | ratio (Mean) |
|---|
| Cycle 2 Day 1/Cycle 1 Day 8 | Cycle 4 Day 1/Cycle 1 Day 8 |
|---|
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 3.24370 | 3.95950 |
,| Phase 2 Stage 2: Isatuximab Alone | 521.38338 | 3.58378 |
Pharmacokinetic Assessment: Phase 2 Stage 2: Plasma Concentration of Isatuximab Before Treatment Administration (Ctrough)
(NCT01084252)
Timeframe: At Day 1, 8, and 22
| Intervention | mcg/mL (Geometric Mean) |
|---|
| Day 7 | Day 14 | Day 28 |
|---|
| Phase 2 Stage 2: Isatuximab + Dexamethasone | 128 | 214 | 305 |
,| Phase 2 Stage 2: Isatuximab Alone | 137 | 230 | 360 |
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. (NCT01084252)
Timeframe: Baseline, Day 1 of Cycles 4, 7, 10, 13, 16, 19, and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | score on a scale (Mean) |
|---|
| Cycle 4 day 1 | Cycle 7 day 1 | Cycle 10 day 1 | Cycle 13 day 1 | End of treatment |
|---|
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | -4.78 | 9.00 | 10.33 | -9.00 | -10.00 |
,| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 4.89 | 1.00 | -2.60 | -5.00 | -9.00 |
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. (NCT01084252)
Timeframe: Baseline, Day 1 of Cycles 4, 7, 10, 13, 16, 19, and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | score on a scale (Mean) |
|---|
| Cycle 4 day 1 | Cycle 7 day 1 | Cycle 10 day 1 | Cycle 13 day 1 | Cycle 16 day 1 | End of treatment |
|---|
| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | -5.75 | -2.50 | 0.50 | 14.00 | 5.00 | -18.50 |
Phase 2 Stage 1: Change From Baseline in Euro Quality of Life 5 Dimension (EQ-5D) Generic Health Status - Visual Analogue Scale Scores
EQ-5D was a standardized HRQL questionnaire consisting of EQ-5D descriptive system and Visual Analogue Scale (VAS). EQ-5D VAS was used to record a participant's rating for his/her current health-related quality of life state and captured on a vertical VAS (0-100), where 0 = worst imaginable health state and 100 = best imaginable health state. (NCT01084252)
Timeframe: Baseline, Day 1 of Cycles 4, 7, 10, 13, 16, 19, and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | score on a scale (Mean) |
|---|
| Cycle 4 day 1 | Cycle 7 day 1 | Cycle 10 day 1 | Cycle 13 day 1 | Cycle 16 day 1 | Cycle 19 day 1 | End of treatment |
|---|
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | 2.00 | -6.00 | -10.33 | -5.00 | 0.67 | -5.50 | -11.60 |
Phase 2 Stage 1: Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Multiple Myeloma Specific Module With 20 Items (EORTC QLQ-MY20) Scores: Disease Symptom Subscale Score
EORTC QLQ-MY20 is a validated questionnaire to assess the overall quality of life in participants with MM. It has 4 subscales: body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). Disease symptoms subscale used 4-point scale ranged from 1= 'Not at All' to 4= 'Very Much'. Scores were averaged, and transformed to 0 -100 scale, where higher scores = more symptoms and lower health-related quality of life (HRQL) and lower score = less symptoms and more HRQL. (NCT01084252)
Timeframe: Baseline, Day 1 of Cycles 2, 3, 4, 5, 6, 7, 8, 9, 10 and EOT (anytime up to 77 weeks for Stage 1a arms and 53 weeks for stage 1b arm)
| Intervention | score on a scale (Mean) |
|---|
| Cycle 2 day 1 | Cycle 3 day 1 | Cycle 4 day 1 | Cycle 5 day 1 | Cycle 6 day 1 | Cycle 7 day 1 | Cycle 8 day 1 | Cycle 9 day 1 | Cycle 10 day 1 | End of treatment |
|---|
| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W | -3.42 | -5.05 | -3.89 | 0.51 | 1.23 | -3.70 | -2.78 | -10.00 | 0.00 | 7.78 |
,| Phase 2 Stage 1a: Isatuximab 10mg/kg Q2W; Then Q4W | 0.93 | -5.98 | -10.00 | -9.03 | -15.08 | -18.06 | -15.28 | -16.67 | -15.28 | 24.07 |
,| Phase 2 Stage 1a: Isatuximab 3mg/kg Q2W | 5.56 | 7.94 | 8.33 | -6.94 | 8.33 | 2.78 | -5.56 | 5.56 | 0.00 | -9.72 |
,| Phase 2 Stage 1b: Isatuximab 20mg/kg QW and Then Q2W | 2.61 | -1.52 | 0.62 | -6.67 | -6.94 | -11.11 | -4.17 | -6.94 | -6.67 | 25.00 |
Brain NK1-receptor Occupancy at 48 Hours Post Dose
(NCT01111851)
Timeframe: 48 hours post dose
| Intervention | Percent of occupancy (Geometric Mean) |
|---|
| Fosaprepitant 150 mg | 98.62 |
| Aprepitant 165 mg | 98.79 |
Brain NK1-receptor Occupancy at 24 Hours Post Dose
(NCT01111851)
Timeframe: 24 hours post dose
| Intervention | Percent of occupancy (Geometric Mean) |
|---|
| Fosaprepitant 150 mg | 100.40 |
| Aprepitant 165 mg | 100.20 |
Brain NK1-receptor Occupancy at 120 Hours Post Dose
(NCT01111851)
Timeframe: 120 hours post dose
| Intervention | Percent of occupancy (Geometric Mean) |
|---|
| Fosaprepitant 150 mg | 59.93 |
| Aprepitant 165 mg | 54.32 |
Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)
(NCT01111851)
Timeframe: 30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitant
| Intervention | Percent of occupancy (Geometric Mean) |
|---|
| Fosaprepitant 150 mg | 100.25 |
| Aprepitant 165 mg | 99.99 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1.7 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.20 |
Disease Free Survival (DFS) in Average Risk (AR) Patients Based on the Methotrexate Dose Randomization
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. (NCT01190930)
Timeframe: 5.7 years
| Intervention | percent probability (Number) |
|---|
| B-ALL Average Risk: MTX 20 mg/m^2/Week Starting Dose | 95.05 |
| B-ALL Average Risk: MTX 40 mg/m^2/Week Starting Dose | 94.17 |
DFS in Average Risk (AR) Patients Based on the Pulse Frequency Randomization
DFS is calculated as the time from randomization at the end of interim maintenance II to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. (NCT01190930)
Timeframe: 5.7 years
| Intervention | percent probability (Number) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | 94.10 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | 95.13 |
DFS for SR Down Syndrome Patients With Standardized Treatment and Enhanced Supportive Care
DFS is calculated as the time from end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. The 5-year DFS and 95% confidence interval for these patients will be estimated. (NCT01190930)
Timeframe: 5.1 years
| Intervention | percent probability (Number) |
|---|
| Standard Risk With Down Syndrome | 89.77 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -1.12 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.02 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for each randomization group will be reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -1.19 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | 0.21 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.27 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.28 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 1 Year
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.39 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Maintenance Cycle 1: Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 1 Year
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.36 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1 Year
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.59 |
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Genetic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.62 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2 Months
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.87 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL at End of Consolidation Therapy-Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 2 Months
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.84 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Right
Strength in the right ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 4.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -1.12 |
Characterize Vincristine-associated Neuropathy in Children Undergoing Therapy for Average Risk (AR) ALL 12 Months Post Therapy: Left
Strength in the left ankle dorsiflexors averaged over two measurements. Age and gender standardized mean and standard deviation for the cohort will be reported. (NCT01190930)
Timeframe: 4.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -1.19 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.5 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.74 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1.7 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.63 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 4: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1.7 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.84 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1 Year
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.19 |
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Social Functioning
Age standardized Quality of life, measured by the Social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.40 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 1: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 1 year
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.86 |
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2 Months
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.42 |
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Physical
Age and gender standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2 Months
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -1.44 |
Burden of Therapy in AR Patients Overall at End of Consolidation Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2 Months
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -1.21 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.27 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.34 |
Burden of Therapy in Boy AR Patients Overall at End of Therapy: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.67 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.64 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.67 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.72 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.77 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported. (NCT01190930)
Timeframe: 1.7 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.16 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.25 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported. (NCT01190930)
Timeframe: 1.7 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.62 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.64 |
Burden of Therapy in AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Maintenance Cycle 4: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with means and standard deviation reported. (NCT01190930)
Timeframe: 1.7 years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.80 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.89 |
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.46 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.33 |
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.85 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.47 |
Burden of Therapy in Boy AR Patients by Vincristine Pulse Frequency Randomization Groups (4 Week vs. 12 Week) at End of Therapy: Emotional
Age standardized Quality of life, measured by the emotional subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated for each group with mean and standard deviation reported. (NCT01190930)
Timeframe: 3.2 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk: VCR/DEX Pulse Every 4 Weeks | -0.71 |
| B-ALL Average Risk: VCR/DEX Pulse Every 12 Weeks | -0.51 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Physical
Age standardized Quality of life, measured by the physical subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.66 |
Burden of Therapy in AR Patients Overall at End of Maintenance Cycle 7 (Boys)/End of Therapy (Girls): Social Functioning
Age standardized Quality of life, measured by the social functioning subscale of Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL), will be calculated with mean and standard deviation reported. (NCT01190930)
Timeframe: 2.4 Years
| Intervention | Z-Score (Mean) |
|---|
| B-ALL Average Risk | -0.30 |
DFS in Low Risk (LR) Patients Based on Randomization to 1 of 2 Low-intensity Regimens
DFS is calculated as the time from randomization at the end of Induction to first event (relapse, second malignancy, remission death) or date of last contact. Five year DFS estimates will be calculated from the point of randomization for both groups. Two-sided 95% confidence intervals will be calculated. (NCT01190930)
Timeframe: 5.1 years
| Intervention | percent probability (Number) |
|---|
| B-ALL Low Risk Arm I (LR-M) | 98.75 |
| B-ALL Low Risk Arm II (LR-C) | 98.50 |
Sample Collection of Central Path Review Slides in B-LLy Patients
Percent of B-LLy patients who had adequate/usable samples of samples collected will be reported. (NCT01190930)
Timeframe: Up to 1 month
| Intervention | percentage of patients (Number) |
|---|
| B-LLy | 89.7 |
Overall Survival (OS) for B-LLy Patients
OS is calculated as the time from study enrollment to death or date of last contact. The 5-year OS and 95% confidence interval for these patients will be estimated. (NCT01190930)
Timeframe: 5 years
| Intervention | percent probability (Number) |
|---|
| B-LLy | 93.97 |
Event Free Survival (EFS) for B-LLy Patients
EFS is calculated as the Time from study enrollment to first event (induction failure, relapse, second malignancy, remission death) or date of last contact. The 5-year EFS and 95% confidence interval for these patients will be estimated. (NCT01190930)
Timeframe: 5 years
| Intervention | percent probability (Number) |
|---|
| B-LLy | 94.54 |
The Percent of Patients With Minimal Residual Disease (MRD) Status Changing to Negative at Day 100 (Post-AHCT), Among Patients With MRD Positive at the End of Induction (EOI).
Patients were treated with induction therapy (VRD) followed by autologous hematopoietic cell transplant (AHCT). MRD status of a patient with at least partial response was evaluated at the end of induction (EOI) and day 100 (post-AHCT). MRD of a patient is measured by seven-color flow cytometry. (NCT01215344)
Timeframe: 6-months post ASCT
| Intervention | percentage of participants (Number) |
|---|
| VELCADE, Lenalidomide, Dexamethasone (VRD) | 30 |
Progression Free Survival by MRD Status at Day 100.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions (NCT01215344)
Timeframe: up to 7 years
| Intervention | years (Median) |
|---|
| MRD Negative at Day 100 | 2.64 |
| MRD Status Positive at Day 100 (Post-AHCT) | NA |
Number of Participants With Complete Resolution
Defined as number of patients with chalazion size regression of 100% (NCT01230593)
Timeframe: 4-6 weeks
| Intervention | participants (Number) |
|---|
| Hot Compress | 13 |
| Hot Compress + Tobramycin Drops and Ointment | 12 |
| Hot Compress + Tobramycin/Dexamethasone Drops and Ointment | 11 |
Chalazion Size Difference Post-Treatment
Change of size of eyelid chalazion in millimeters from baseline to 4-6 weeks post-treatment (NCT01230593)
Timeframe: baseline and 4-6 weeks
| Intervention | millimeters (Mean) |
|---|
| Hot Compress | 1.20 |
| Hot Compress + Tobramycin Drops and Ointment | 1.69 |
| Hot Compress + Tobramycin/Dexamethasone Drops and Ointment | 1.54 |
Change From Baseline of Mean Score Pain Severity (BPI-SF)
"The change from baseline of the mean score of pain severity at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 (No pain, No interference) to 10 (Pain as bad as you can imagine, Highest imaginable interference) numeric rating scale." (NCT01239797)
Timeframe: From baseline up to approximately 38 months
| Intervention | Score on a scale (Mean) |
|---|
| Lenalidomide + Dexamethasone + Elotuzumab | 0.52 |
| Lenalidomide + Dexamethasone | -0.04 |
Objective Response Rate (ORR)
Objective response rate (ORR) defined as the percentage of participants with a best response on-study of partial response (PR) or better (stringent CR [sCR], complete response [CR], very good partial response [VGPR], and partial response [PR]) based on the Independent Review Committee (IRC) assessment of best response using the European Group for Blood and Bone Marrow Transplant (EBMT) assessment criteria. Participants were censored at the last adequate assessment prior to the start of any subsequent systemic-therapy or at the last adequate assessment prior to 2 missing assessments (> 10 weeks). Participants who died more than 10 weeks after the randomization date and had no on-treatment assessment were censored at the randomization date. Clinical deterioration was not considered progression. Assessments were made every 4 weeks. (NCT01239797)
Timeframe: From randomization up to approximately 38 months
| Intervention | Percentage of participants (Number) |
|---|
| Lenalidomide + Dexamethasone + Elotuzumab | 78.5 |
| Lenalidomide + Dexamethasone | 65.5 |
Change From Baseline of Mean Score Pain Interference (BPI-SF)
"The change from baseline of the mean score of pain interference at the end of treatment using the Brief Pain Inventory-Short Form (BPI-SF). The BPI-SF is a self administered questionnaire developed to assess the severity of pain (the sensory dimension) as well as the degree to which pain interferes with function (the reactive dimension). The BPI-SF uses 0 (No pain, No interference) to 10 (Pain as bad as you can imagine, Highest imaginable interference) numeric rating scale." (NCT01239797)
Timeframe: From baseline up to approximately 38 months
| Intervention | Score on a scale (Mean) |
|---|
| Lenalidomide + Dexamethasone + Elotuzumab | 0.95 |
| Lenalidomide + Dexamethasone | 0.48 |
Overall Survival (OS)
Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: 10 years
| Intervention | Months (Median) |
|---|
| Treatment (Chemotherapy, Transplant) | 55.9 |
Probability of Being BCR-ABL Negative in the Bone Marrow and Peripheral Blood at the Completion of the CNS Prophylaxis Course (Restricted to Those Patients Achieving a CR)
Proportions will be estimated based on the combined and individual cohorts. (NCT01256398)
Timeframe: 10 years
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 0.667 |
Response
Proportion of patients reaching a CR. A CR requires the following: an absolute neutrophil count (segs and bands) >1000/μL, no circulating blasts, platelets >100,000/μL; adequate bone marrow cellularity with trilineage hematopoiesis, and <5% marrow leukemia blast cells. All previous extramedullary manifestations of disease must be absent (e.g., lymphadenopathy, splenomegaly, skin or gum infiltration, testicular masses, or CNS involvement). (NCT01256398)
Timeframe: 10 years
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | .9846 |
Feasibility of Maintenance Therapy in This Patient Population (Restricted to Those Patients Achieving a CR). Feasibility Will be Defined as the Number of Deaths Ocuring.
Proportions will be estimated based on the combined and individual cohorts. (NCT01256398)
Timeframe: 10 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Chemotherapy, Transplant) | 5 |
Disease Free Survival (DFS)
Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: 10 years
| Intervention | Months (Median) |
|---|
| Treatment (Chemotherapy, Transplant) | 29.7 |
Disease Free Survival Defined From the Date of First Induction Complete Response (CR) to Relapse or Death Due to Any Cause
Estimated using the Kaplan-Meier estimator. Proportions will be estimated using point as well as interval estimators. All interval estimators will be constructed using the finite sample size sampling distribution at the unadjusted two-sided level of 0.05. (NCT01256398)
Timeframe: At 3 years after CR
| Intervention | percentage of patients (Number) |
|---|
| Treatment (Chemotherapy, Transplant) | 52.6 |
Number of Participants With Complete Control Defined as no Vomiting and no Use of Rescue Medications (for Nausea or Emesis)
Number of participants who had complete control defined by no vomiting (NCT01275664)
Timeframe: During the 6 days following chemotherapy
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Granisetron, Dexamethasone, Aprepitant) | 1 |
Frequency of Adverse Effects as Assessed by the NCI CTCAE v 4.0
Adverse events at least possibly related to treatment (NCT01275664)
Timeframe: Up to day 6
| Intervention | Participants (Count of Participants) |
|---|
| Constipation | Fatigue | Diarrhea | Hyponatremia | Alanine Aminotransferase Increased | GGT Increased |
|---|
| Treatment (Granisetron, Dexamethasone, Aprepitant) | 1 | 1 | 1 | 1 | 1 | 1 |
Time it Takes for Nerve Block to Wear Off
Does adding dexamethasone and / or buprenorphine prolong the analgesia provided by a popliteal fossa nerve block? (NCT01277159)
Timeframe: up to 72 hours
| Intervention | hours (Mean) |
|---|
| Control Nerve Block. IV Dexamethasone (4 mg). | 30.4 |
| Nerve Block With Dexamethasone (4 mg). IV Saline. | 45.1 |
| Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorp | 32.2 |
| Nerve Block With Buprenorphine (0.3 mg). IV Dexamethasone ( | 45.6 |
| Nerve Block With Dexamethasone (4 mg) / Block Buprenorphine | 45.6 |
Post-dexamethasone Cortisol Level
(NCT01294319)
Timeframe: Cortisol obtained at 8-9 AM after dexamethasone taken between 11 pm and midnight
| Intervention | mcg/dL (Mean) |
|---|
| Endurance-trained Young Athletes | 11.98 |
| Sedentary Young Adults | 9.98 |
Proportion of Suppressors After Dexamethasone
"All subjects will take 0.25mg dexamethasone as an outpatient between 2300 and 2400h and will then report to the clinic by 0800h next day for the final visit.~At the final visit, cortisol response to dexamethasone suppression was assessed. The cortisol response was dichotomized (suppression vs. non-suppression, using 1.8 ug/dL as the cutoff point) and compared between the two groups,Sedentary Young Adults and Endurance-trained Young Athletes." (NCT01294319)
Timeframe: cortisol measured between 8 and 9 after dexamethasone was taken between 11 PM and midnight
| Intervention | Participants (Count of Participants) |
|---|
| Endurance-trained Young Athletes | 0 |
| Sedentary Young Adults | 1 |
The Secondary Efficacy Endpoint is the Visual Acuity Score Based on Best Corrected Visual Acuity (BCVA) at Week 24
Change in BCVA at Week 24 from baseline (NCT01295112)
Timeframe: 24 weeks
| Intervention | letters (Mean) |
|---|
| Group 1 | 16.20 |
| Group 2 | 13.55 |
Objective Response Rate (ORR)
ORR is defined as the percentage of participants with objective response among all randomized subjects. Participants with an objective response are those participants experiencing a partial response (PR) or better, based on Independent Review Committee (IRC) assessment, as per EBMT criteria. (NCT01335399)
Timeframe: From randomization to primary completion date (approximately 8 years)
| Intervention | Percent of Participants (Number) |
|---|
| E-Ld Cohort | 82.9 |
| Ld Cohort | 79.4 |
Progression Free Survival (PFS) Rate at Specific Time-points
PFS rate is defined as the percentage of participants experiencing PFS at the defined time-points. (NCT01335399)
Timeframe: From randomization to the specified time-point (up to 5 years)
| Intervention | Percent of participants (Number) |
|---|
| 1 year | 2 year | 3 year | 4 year | 5 year |
|---|
| E-Ld Cohort | 0.77 | 0.59 | 0.46 | 0.36 | 0.26 |
,| Ld Cohort | 0.76 | 0.55 | 0.41 | 0.33 | 0.25 |
Progression-Free Survival (PFS)
"PFS is defined as the time from randomization to the date of the first documented tumor progression (as determined by the Independent Review Committee (IRC)) or death due to any cause.~The IRC conducted a blinded, independent review of the tumor assessments based on the European Group for Blood and Bone Marrow Transplant (EBMT) criteria.~Censoring rules applied:~Participants receiving subsequent systemic anti-myeloma therapy prior to documented progression were censored at the date of the last adequate tumor assessment prior to new therapy.~Participants who had an event (progression or death) > 10 weeks after their last tumor assessment were censored at their last adequate tumor assessment prior to the event.~Participants without progression or death (and not receiving subsequent therapy prior to progression) were censored at their last adequate tumor assessment.~Participants without any post-baseline tumor assessments were censored on the date of randomization" (NCT01335399)
Timeframe: From randomization to date of first documented tumor progression or death due to any cause (up to 8 years)
| Intervention | Months (Median) |
|---|
| E-Ld Cohort | 31.38 |
| Ld Cohort | 29.47 |
Mean Change From Baseline of Pain Severity Score and Pain Interference Score
"Pain severity (sensory dimension) and pain interference (reactive dimension, assessing the degree to which pain interferes with function) are measured using the Brief Pain Inventory- Short Form (BPI-SF).~BPI-SF numeric rating scale goes from 0 (No pain) to 10 (Pain as bad as you can imagine)." (NCT01335399)
Timeframe: From Baseline to End of Treatment (approximately 8 years)
| Intervention | Rating score (Mean) |
|---|
| Pain Severity | Pain Interference |
|---|
| E-Ld Cohort | 0.02 | 0.33 |
,| Ld Cohort | -0.25 | -0.18 |
Overall Survival (OS)
"Survival is defined as the time from randomization to the date of death. A participant who did not die had his or her survival duration censored at the date of last contact ('last known date alive)." (NCT01335399)
Timeframe: From randomization to the date of death (up to 8 years)
| Intervention | Months (Median) |
|---|
| E-Ld Cohort | 60.42 |
| Ld Cohort | 57.56 |
Time-to-next Treatment
(NCT01355705)
Timeframe: 9 months
| Intervention | days (Median) |
|---|
| Amrubicin + Lenalidomide + Dexamethasone | 92 |
Duration of Response (DOR)
(NCT01355705)
Timeframe: 140 days
| Intervention | days (Median) |
|---|
| Amrubicin + Lenalidomide + Dexamethasone | 133 |
Progression-free Survival (PFS)
"Progression-free survival (PFS) is alive and free from progression, per the modified International Myeloma Working Group Uniform Response Criteria, defined as any of:~Serum monoclonal protein ≥ 125% baseline and/or ≥ +0.5 g/dL from baseline,~Urine monoclonal protein ≥ 125% baseline and/or ≥ +200 mg/24 hour from baseline~New or increased bone lesions or plasmacytomas~Serum calcium > 11.5 mg/dL (attributed to increased plasma cells)" (NCT01355705)
Timeframe: 9 months
| Intervention | days (Median) |
|---|
| Amrubicin + Lenalidomide + Dexamethasone | 96 |
4-year Event Free Survival
Event Free Survival defined as the time from the start of therapy to time of primary refractory disease, relapse from CR, death from any cause or last follow-up. Kaplan-Meier method will be utilized to analyze event free survival for the 4 year percent alive and in CR. (NCT01363128)
Timeframe: Up to 4 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Hyper-CVAD, Ofatumumab) | 41 |
4-Year Overall Survival
Overall Survival is defined as time from date of treatment start until date of death due to any cause or last Follow-up. For continuous data, summary statistics including n, mean, standard deviation, median, minimum and maximum will be computed. The posterior median time to event and it 95% credible interval will be estimated. Kaplan-Meier method, Log rank test and Cox proportional hazards regression modeling will be utilized to analyze survival at 4 years. (NCT01363128)
Timeframe: Up to 4 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Hyper-CVAD, Ofatumumab) | 47 |
Number of Participants With Complete Remission (CR)
Complete Remission is Normalization of the peripheral blood and bone marrow with 5% or less blasts in marrow with a granulocyte count of 1 x 109/L or above and a platelet count of 100x 109/L or above. Complete resolution of all sites of extramedullary disease is required for CR. (NCT01363128)
Timeframe: Up to 8 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Hyper-CVAD, Ofatumumab) | 68 |
Phase I: The Maximum Tolerated Dose (MTD) of Temsirolimus in Combination With Bortezomib, Rituximab and Dexamethasone
Temsirolimus in combination with bortezomib, rituximab, dexamethasone were to be escalated using a standard 3+3 design. The MTD was defined as the highest dose level at which no more than 0 in 3 or 1 in 6 participants experienced a dose-limiting toxicity (DLT) during the first 28-day cycle of treatment. (NCT01381692)
Timeframe: Assessed during cycle 1 (28 days)
| Intervention | mg (Number) |
|---|
| Arm A (Phase I: Temsirolimus Dose Level 1, Rituximab, Bortezomib, Dexamethasone) | NA |
| Arm B (Phase I: Temsirolimus Dose Level 2, Rituximab, Bortezomib, Dexamethasone) | NA |
Progression Free Survival at 24 Months
following the 3-phase comprehensive treatment approach including induction with BD, followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. (NCT01383759)
Timeframe: 24 months
| Intervention | percentage of patients (Number) |
|---|
| Amyloidosis | 68 |
Percentage of Participants Experiencing Progression Free Survival at 12 Months
of a 3-phase comprehensive treatment approach including induction with BD followed by risk adapted HDM/ASCT, followed by consolidation/maintenance therapy with BD in patients with AL amyloidosis. (NCT01383759)
Timeframe: 12 months
| Intervention | percentage of patients (Number) |
|---|
| Amyloidosis | 84 |
Participants Evaluated for Toxicity
Toxicities will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. (NCT01383759)
Timeframe: 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Amyloidosis | 19 |
| Monoclonal Ig DepositionDisease (MIDD) | 1 |
Mean Terminal-phase Elimination Half-life (T-Half) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. T-Half was measured in hours (h). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group. (NCT01393964)
Timeframe: Day 1 of Cycle 1 to 28 days post dose
| Intervention | h (Mean) |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 204 |
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 237 |
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 218 |
Geometric Mean Area Under Serum Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration AUC(0-T) and From Time Zero Extrapolated to Infinite Time AUC(INF) of Elotuzumab Following Cycle 1, Day 1 - Grouping by C-G CrCl Method
The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD participants had 2 additional sample times: immediately prior to and immediately after dialysis. AUC was measured in µg*h/mL. PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group (NCT01393964)
Timeframe: Day 1 of Cycle 1 to 28 days post dose
| Intervention | µg*h/mL (Geometric Mean) |
|---|
| AUC (0-T) | AUC (INF) |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 45937 | 51227 |
,| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 39559 | 46401 |
,| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 50080 | 60255 |
Number of Participants With Persistent Elotuzumab Anti-drug Antibodies (ADA) and Number of Participants ADA Positive at Cycle 2 Pre-dose.
Serum samples were evaluated for the presence of ADAs using a validated bridging electrochemiluminescence (ECL) immunoassay. Samples in: Cycle 1, Day 1 0 h (pre-dose), Cycle 2, Day 1(Study Day 29), 0 h (pre-dose; 672 h post-dose), Cycle 3, Day 1, 0 h and in cycle thereafter, at end of study/discontinuation, and at 30 and 60 day follow up visits post treatment. ADA Positive Participant: baseline negative with at least one ADA positive sample at any time after initiation of treatment or baseline positive with at least one ADA positive sample at any time after initiation of treatment with a titer 9-fold greater than the baseline; Persistent Positive: ADA positive at 2 or more sequential timepoints at least 12 weeks apart; Last Sample Positive: Not persistent positive and ADA Positive Sample in the last sampling timepoint; Other Positive: not persistent positive with ADA negative sample in the last sampling; ADA Negative: no ADA positive sample after the initiation of treatment. (NCT01393964)
Timeframe: From first dose (Day 1) to last dose plus 60 days, up to Primary Endpoint (June 2014), approximately 2 years
| Intervention | participants (Number) |
|---|
| Baseline ADA Positive | On-Study ADA Positive | Positive at Cycle 2 pre-dose | Persistent Positive | Last Sample Positive | Other Positive | On-Study ADA Negative |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 0 | 1 | 1 | 0 | 1 | 0 | 5 |
,| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 1 | 2 | 2 | 0 | 1 | 1 | 4 |
,| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 0 | 1 | 0 | 0 | 0 | 1 | 3 |
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs) Leading to Discontinuation, and Who Died
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. (NCT01393964)
Timeframe: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
| Intervention | participants (Number) |
|---|
| Deaths | Any SAE | AEs Leading to Discontinuation |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 0 | 7 | 1 |
,| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0 | 3 | 1 |
,| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 0 | 5 | 4 |
Number of Participants With Worst Toxicity Grade Chemistry Laboratory Tests
Sodium high (H) Gr 1:>ULN - 150; Gr 2: >150 - 155; Gr 3: >155 - 160; Gr 4: >160 mmol/L; Sodium low(L) Gr 1:ULN - 5.5; Gr 2: >5.5 - 6.0; Gr 3: > 6.0 - 7.0; Gr 4: >7.0 mmol/L; Potassium (L) Gr 1: ULN - 11.5, Gr2:>11.5 - 12.5, Gr3: 12.5 - 13.5, Gr4: >13.5. (NCT01393964)
Timeframe: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
| Intervention | participants (Number) |
|---|
| Sodium High Any Grade | Sodium High Grade 3-4 | Sodium Low Any Grade | Sodium Low Grade 3-4 | Potassium High Any Grade | Potassium High Grade 3-4 | Potassium Low Any Grade | Potassium Low Grade 3-4 | Bicarbonate Any Grade | Bicarbonate Grade 3-4 | Calcium High Any Grade | Calcium High Grade 3-4 | Calcium Low Any Grade | Calcium Low Grade 3-4 | Glucose High Any Grade | Glucose High Grade 3-4 | Glucose Low Any Grade | Glucose Low Grade 3-4 |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 2 | 0 | 5 | 0 | 4 | 3 | 6 | 1 | 6 | 0 | 3 | 1 | 8 | 2 | 7 | 3 | 1 | 0 |
,| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 2 | 0 | 2 | 1 | 2 | 0 | 2 | 0 | 5 | 0 | 1 | 0 | 4 | 0 | 7 | 3 | 1 | 0 |
,| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 3 | 0 | 6 | 1 | 2 | 0 | 5 | 2 | 8 | 0 | 0 | 0 | 6 | 1 | 9 | 4 | 0 | 0 |
Number of Participants With Worst Toxicity Grade Renal and Liver Function Laboratory Tests
NCI CTCAE, version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Upper Limits of Normal (ULN). Alanine transaminase (ALT); Aspartate aminotransferase (AST); Alkaline phosphatase (ALP). ALT Grade (Gr)1:>1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. AST Gr 1: >1.0 to 2.5*ULN; Gr 2: >2.5 to 5.0*ULN; Gr 3: >5.0 to 20.0*ULN; Gr 4: >20.0*ULN. Total bilirubin Gr 1: >1.0 to 1.5*ULN; Gr 2: >1.5 to 3.0*ULN; Gr 3: >3.0 to 10..0*ULN; Gr 4: >10.0.0*ULN. ALP (U/L) Gr1:>1.0 to 2.5*ULN, Gr2:>2.5 to 5.0*ULN, Gr3:>5.0 to 20.0*ULN, Gr4:>20.0*ULN. Albumin (low) Gr 1:1 - 1.5*baseline (BL)to >ULN - 1.5*ULN; Gr 2: >1.5 - 3.0*BL to > 1.5 - 3.0*ULN; Gr 3: >3.0*BL to > 3.0 - 6.0*ULN; Gr 4: >6.0*ULN. (NCT01393964)
Timeframe: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
| Intervention | participants (Number) |
|---|
| ALP Any Grade | ALP Grade 3-4 | AST Any Grade | AST Grade 3-4 | ALT Any Grade | ALT Grade 3-4 | Bilirubin Any Grade | Bilirubin Grade 3-4 | Creatinine Any Grade | Creatinine Grade 3-4 | Albumin Any Grade | Albumin Grade 3-4 |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 7 | 0 | 5 | 0 | 5 | 0 | 2 | 0 | 9 | 9 | 7 | 0 |
,| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0 | 0 | 3 | 0 | 2 | 0 | 1 | 0 | 0 | 0 | 2 | 0 |
,| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 3 | 0 | 2 | 0 | 5 | 0 | 1 | 0 | 9 | 2 | 7 | 0 |
Number of Participants With Worst Toxicity Grade Hematology Laboratory Tests
National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 was used to measure toxicity scale. Lower Limits of Normal (LLN). Hemoglobin Gr 1:NCT01393964)
Timeframe: From first dose (Day 1) to last dose plus 60 days (Assessed up to July 2016, approximately 54 months)
| Intervention | participants (Number) |
|---|
| Hemoglobin Any Grade | Hemoglobin Grade 3-4 | Platelet Count Any Grade | Platelet Count Grade 3-4 | Leukocytes Any Grade | Leukocytes Grade 3-4 | Lymphocytes (Abs) Any Grade | Lymphocytes (Abs) Grade 3-4 | Neutrophil Count (Abs) Any Grade | Neutrophil Count (Abs) Grade 3-4 |
|---|
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 9 | 6 | 8 | 2 | 6 | 2 | 9 | 5 | 6 | 2 |
,| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 8 | 0 | 7 | 0 | 8 | 3 | 8 | 6 | 6 | 3 |
,| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 9 | 2 | 8 | 2 | 8 | 1 | 9 | 9 | 5 | 1 |
Geometric Mean Apparent Volume of Distribution (Vz) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Vz was measured in mL per kilogram body weight (mL/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group. (NCT01393964)
Timeframe: Day 1 of Cycle 1 to 28 days post dose
| Intervention | mL/kg (Geometric Mean) |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 59.4 |
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 54.6 |
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 61.2 |
Geometric Mean Maximum Observed Serum Concentration (Cmax) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
The quantification of elotuzumab in human serum was performed using a validated Enzyme-linked immunoassay (ELISA). Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. Cmax was measured in micrograms per milliliter (µg/mL). Pharmacokinetic (PK) parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group. (NCT01393964)
Timeframe: Day 1 of Cycle 1 to 28 days post dose
| Intervention | µg/mL (Geometric Mean) |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 217 |
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 226 |
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 218 |
Geometric Mean Total Body Clearance (CLT) of Elotuzumab Following Cycle 1, Day 1 Dose Administration - Grouping by Cockcroft-Gault Creatinine Clearance Method
The quantification of elotuzumab in human serum was performed using validated ELISA. Cycle 1, day 1 sample times for all participants: 0 hour (h) pre-dose, end of infusion, 30 minutes (min) post end of infusion, 2 h, 4 h , and 24 h post end of infusion. Trough samples were obtained in subsequent cycles and at 30 day and 60 day follow-up visits at end of treatment. ESRD had 2 additional samples: immediately prior to and immediately after dialysis. CLT was measured in mL per hour per kilogram body weight (mL/h/kg). PK parameter renal function group assignment criteria differed slightly from the criteria for safety and efficacy analyses (specifically for the SRI group). PK criteria: All participants with at least one pretreatment value ≥ 90 mL/min were assigned to the NRF group. All those with at least one pretreatment value < 30 mL/min were assigned to the SRI group. All those with a screening diagnosis of ESRD, were assigned to the ESRD group. (NCT01393964)
Timeframe: Day 1 of Cycle 1 to 28 days post dose
| Intervention | mL/h/kg (Geometric Mean) |
|---|
| Elotuzumab + LD in Normal Renal Function (NRF) Participants | 0.215 |
| Elotuzumab + LD in Severe Renal Impairment (SRI) Participants | 0.166 |
| Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants | 0.195 |
Effect of Perioperative Steroid for the Postoperative Swelling After Orthognathic Surgery
Measure of facial swelling will be performed using 3-dimensional photogrammetry. The 3d photo acquisition is non-invasive without radiation concern. The images will be taken before and after surgery to measure and compare the degree of facial swelling. Side effects from the steroid use are expected to be low under normal clinical dosage, but will also be monitored. Symptoms of wound infection, psychosis, and prolonged wound healing will be studied. There should be no long term complication, since the steroid use is one single dose. (NCT01431014)
Timeframe: 1 year
| Intervention | ml (Mean) |
|---|
| 36 hours postoperatively | 1week postoperatively | 1month postoperatively |
|---|
| "DexamethasoneHigh-dose" | 167.06 | 61.39 | 29.85 |
,| "DexamethasoneLow-dose" | 190.73 | 57.62 | 19.34 |
Macular Function Using Microperimetry
To determine if there is change in mean macular sensitivity using microperimetry at 48 weeks compared to baseline for both the PRN and Q16weeks treatment groups (NCT01449682)
Timeframe: baseline to 48 weeks
| Intervention | dB (Mean) |
|---|
| Baseline | Final Visit |
|---|
| Ozurdex PRN | 2.7 | 4.2 |
,| Ozurdex Q16 Weeks | 12.7 | 10.7 |
Macular Function Using Multi-focal ERG
To determine if there is a change in central amplitude responses using multifocal ERG at 48 weeks compared to baseline values for both the PRN and Q16weeks treatment groups (NCT01449682)
Timeframe: baseline to 48 weeks
| Intervention | nV/deg2 (Mean) |
|---|
| Baseline | Final Visit |
|---|
| Ozurdex PRN | 3.61 | 18.20 |
,| Ozurdex Q16 Weeks | 6.62 | 30.18 |
To Determine if There is a Change in Central Foveal Thickness (Microns on High Resolution OCT) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups
(NCT01449682)
Timeframe: baseline to 48 weeks
| Intervention | microns (Mean) |
|---|
| Baseline | Final Visit |
|---|
| Ozurdex PRN | 501.7 | 361.4 |
,| Ozurdex Q16 Weeks | 353.5 | 326.7 |
To Determine if There is a Change in Visual Acuity (Number of ETDRS Letters) at 48 Weeks Compared to Baseline Values for Both the PRN and Q16weeks Treatment Groups
(NCT01449682)
Timeframe: baseline to 48 weeks
| Intervention | ETDRS letters (Mean) |
|---|
| Baseline | Final Visit |
|---|
| Ozurdex PRN | 46.4 | 27.8 |
,| Ozurdex Q16 Weeks | 55.6 | 53.2 |
Duration of Sensory Blockade
Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report. (NCT01450007)
Timeframe: Within 48 hours
| Intervention | hours (Mean) |
|---|
| Dexamethasone Block | 16.9 |
| Dexamethasone IV | 18.2 |
| Placebo | 13.8 |
Post Operative Opioid Dose at 24 Hours
(NCT01450007)
Timeframe: approximately 24 hours after surgery
| Intervention | mg morphine equivalents (Mean) |
|---|
| Dexamethasone Block | 12.2 |
| Dexamethasone IV | 17.1 |
| Placebo | 24.1 |
Time Until First Dose of Analgesic
(NCT01450007)
Timeframe: Approximately 10 hours after surgery
| Intervention | hours (Mean) |
|---|
| Dexamethasone Block | 8.4 |
| Dexamethasone IV | 9.2 |
| Placebo | 8.4 |
Patient Satisfaction With Pain Control
Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain. (NCT01450007)
Timeframe: 24 hours, 48 hours, 1 week
| Intervention | units on a scale (Mean) |
|---|
| 24 hours (n=34, 28, 37) | 48 hours (n=42, 37, 41) | 1 week (n=42, 36, 41) |
|---|
| Dexamethasone Block | 7.8 | 8.4 | 9.1 |
,| Dexamethasone IV | 7.9 | 8.7 | 8.8 |
,| Placebo | 7.3 | 7.6 | 8.4 |
Investigator-Assessed Objective Response Rate in Randomized Participants With at Least One FcγRIIIa V Allele
ORR was calculated for participants with a BOR of PR or better, sCR, CR, and VGPR. BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage. Randomized participants with at least 1 FcγRIIIa V allele were a sub-set of all randomized participants. (NCT01478048)
Timeframe: Randomization until 111 events, up to May 2014, approximately 2 years
| Intervention | percentage of participants (Number) |
|---|
| Elotuzumab + Bortezomib + Dexamethasone | 60.0 |
| Bortezomib + Dexamethasone | 61.1 |
Investigator-Assessed Objective Response Rate (ORR) - All Randomized Participants
ORR was calculated for participants with a best overall response (BOR) of partial response (PR) or better, including stringent complete response (sCR), complete response (CR), and very good partial response (VGPR). BOR was determined by the investigator based on myeloma tumor assessments using IMWG criteria: CR=Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow; sCR= CR + normal FLC ratio and absence of clonal cells in bone marrow; VGPR=Serum and urine M-protein detectable by immunofixation but not on electrophoresis or ≥90% reduction in serum M-protein level + urine M-protein level < 100 mg per 24 hour; PR= ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥ 90% or to < 200 mg per 24 hour. ORR= number of participants responding divided by total number of participants randomized, measured as a percentage. (NCT01478048)
Timeframe: Randomization until 111 events, up to May 2014, approximately 2 years
| Intervention | percentage of participants (Number) |
|---|
| Elotuzumab + Bortezomib + Dexamethasone | 64.9 |
| Bortezomib + Dexamethasone | 62.7 |
1 Year Progression-Free Survival Rate - Randomized Participants
PFS rate=Percentage probability of participants experiencing no progression or death up to 1 year, estimated using the Kaplan-Meier method. Response assessed by the investigator: Day 1 (± 7 days) of each cycle per modified IMWG criteria; assessed using ATA (ie, serum and urine M-protein tests performed within 14 days of each other; imaging done if baseline measurable extramedullary plasmacytoma existed). Progression: Any of the following: Increase of 25% from lowest response in 1 or more: serum and/or urine M-component; in those without measurable serum and urine M-protein levels, difference between involved and uninvolved FLC levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). Definite new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing lesions or plasmacytomas. Development of hypercalcemia attributed solely to the plasma cell proliferative disorder. (NCT01478048)
Timeframe: Year 1 after last participant was randomized
| Intervention | percentage probability (Number) |
|---|
| Elotuzumab + Bortezomib + Dexamethasone | 0.39 |
| Bortezomib + Dexamethasone | 0.33 |
Number of Investigator-Assessed Progression-free Survival Events From Randomization to Date of First Tumor Progression or Death Due to Any Cause - All Randomized Participants
PE planned for after at least 103 events (progression/death); analyzed at 111 events. Those who neither progressed nor died were censored on the date of last adequate tumor assessment (ATA), which requires both serum and urine M-protein tests. If no post-baseline tumor assessments/no death, then censored on randomization day. Response assessed: Day 1 (± 7 days) each cycle; 30 and 60 days post treatment. Modified IMWG criteria used. Progression: Any of following: Increase of 25% in serum and/or urine M-component; if no measurable serum, urine M-protein levels, then difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 100 mg/L) ; Bone marrow plasma cell percentage (≥10%). New bone lesions or soft tissue plasmacytomas or increase in size of existing lesions, plasmacytomas. Development of hypercalcemia attributed solely to plasma cell proliferative disorder. First dose occurs within 3 days of randomization. (NCT01478048)
Timeframe: Randomization until 111 events, up to May 2014, approximately 2 years
| Intervention | Events (progression or death) (Number) |
|---|
| Elotuzumab + Bortezomib + Dexamethasone | 52 |
| Bortezomib + Dexamethasone | 59 |
Disease Response Rate After Treatment.
Bone marrow evaluation was performed on Day 35 of study to evaluate treatment response. CR defined as attaining M1 marrow (<5% blasts) with no evidence of circulating blasts or extramedullary disease in addition to recovery of peripheral blood counts (ANC >750/uL and platelet count >75,000/uL). CRp was defined as attaining an M1 marrow with no evidence of circulating blasts or extramedullary disease in addition to recovery of ANC but insufficient recovery of platelets. CRi was attaining M1 marrow with no evidence of circulating blasts or extramedullary disease but insufficient recovery of ANC with or without sufficient recovery of platelets. PR was defined as no evidence of circulating blasts and achievement of M2 marrow (5-25% blasts) without new sites of disease and with recovery of ANC. SD is for patients who did not meet the criteria for PR, CR, CRp, or CRi. PD is an increase of at least 25% in the absolute number of leukemia cells or development of new sites. (NCT01483690)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| complete response (CR) | complete response without platelet recovery (CRp) | complete remission with incomplete recovery (CRi) | stable disease (SD) | patient not evaluable for response |
|---|
| Initial Dose Level | 0 | 1 | 1 | 1 | 2 |
,| Modified Dose Level | 1 | 3 | 3 | 4 | 7 |
Number of Participants Who Experienced a Dose Limiting Toxicity (DLT).
To evaluate the side effects of giving decitabine and vorinostat before and during chemotherapy using the standard drugs vincristine, dexamethasone, PEG-asparaginase and mitoxantrone. (NCT01483690)
Timeframe: 6 weeks
| Intervention | Participants (Count of Participants) |
|---|
| # of patients with DLT | # of patients without DLT | # of patients not evaluable |
|---|
| Initial Dose Level | 2 | 2 | 1 |
,| Modified Dose Level | 1 | 12 | 5 |
Change in Insulin Secretion (AIRg or Acute Insulinogenic Response to Glucose)
We measured the change in insulin secretion (AIRg or acute insulinogenic response to glucose) during the MTT and compared the insulin secretion on the DPP4 inhibitor (sitagliptin) compared to placebo. We had expected the AIRg to be greater with DPP4i compared to placebo. (NCT01488279)
Timeframe: measured twice: on day #8 (after 7 days of study drug and 1 day of IVGTT) of sitagliptin during MTT, then after 4 week washout, measured again on day #8 (after 7 days of study drug + 1 day of IVGTT) of dex + placebo during MTT
| Intervention | pmol/l (Least Squares Mean) |
|---|
| Sitagliptin | 519.6 |
| Placebo | 558.6 |
Change in Glucose Response
Change in glucose response during the MTT. This was the Si (insulin sensitivity). We sought to determine whether there was an improvement in the glucose response after a meal on the DPP4i compared to placebo in the face of steroid (dexamethasone). (NCT01488279)
Timeframe: measured on day #9 (after 7 days of study drug and 1 day of IVGTT) of sitagliptin during MTT, then after 4 week washout, measured again on day #9 (after 7 days of study drug + 1 day of IVGTT) of dex + placebo during MTT
| Intervention | response x 10000 / minute / microUnit/ml (Least Squares Mean) |
|---|
| Sitagliptin | 4.219 |
| Placebo | 4.228 |
Insulin Sensitivity
Insulin Sensitivity measured at the end of each treatment period. The primary outcome variable was the difference in the disposition index (DI) determined as the product of the acute insulin response to glucose (AIRg) x the insulin sensitivity index (SI) in subjects during IVGTT on the 8th day (after 7 days) of on dex + placebo, then a after a washout of approximately 4 weeks, participants crossed over to dex + sitagliptin 100 mg x 7 days. Subjects were randomized to order of medication. The primary analyses will be an ANCOVA, including baseline responses as a covariate. (NCT01488279)
Timeframe: Measured on day #8 (after 8 days of sitagliptin or placebo) followed by a 4 week washout then measured again on day #8 (after 8 days of crossover treatment).
| Intervention | ratio without units (Mean) |
|---|
| Sitagliptin | 1835.4 |
| Placebo | 1846.0 |
Complete Response
Complete response (CR) defined as: No emetic episodes and no rescue medications. This is a cross-over designed study, the outcomes by single dose, two doses and control cycles were evaluated by combining the results from both cycle 1 and cycle 2 according to the treatment received. (NCT01490060)
Timeframe: From Day 1 to Day 5 in two 21-days cycles (Cycle 1 and Cycle 2).
| Intervention | percentage of participants (Number) |
|---|
| Control Cycle (Arm A/Arm B) | 17 |
| Arm A: Single Dose, Day 1 | 10 |
| Arm B: Two Doses, Day 1 + Day 4 | 50 |
Percentage of Participants With Autologous Stem Cell Transplantation
Estimated using simple relative frequencies. The corresponding 95% confidence intervals will be computed using the method proposed in Clopper and Pearson. (NCT01527149)
Timeframe: Up to 6 weeks after the last dose of ofatumumab-chemotherapy, an average of 4 month
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | 73 |
Number of Participants With at Least One Serious Adverse Event
Evaluated using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. (NCT01527149)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | 19 |
Change From Baseline in Percentage of Cells Positive for Ki67
Mean change from baseline in Percentage of Cells Positive for Ki67 by patient response. (NCT01527149)
Timeframe: Baseline and up to 3 years
| Intervention | percentage of cells positive for Ki-67 (Mean) |
|---|
| Not CR | CR |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | -2.5 | NA |
Proportion of Patients Who Experience Complete Remission as Assessed by HSFCM
Established when all CR criteria are met and negative flow cytometry examination of peripheral blood and bone marrow biopsy/aspiration collected at baseline, before courses 3 and 5, within 3 weeks after course 6, on day 100 (if HDC-ASCT eligible), and then every 6 months for 3 years. (NCT01527149)
Timeframe: Up to 3 years
| Intervention | Proportion of participants (Number) |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | .84 |
Time-to-tumor Progression (TTP) at 3 Years
Estimated percentage of patients that progressed at 3 years. Time to Progression distributions obtained using the Kaplan-Meier method. Corresponding confidence intervals using the methodology of Brookmeyer and Crowley will be computed. (NCT01527149)
Timeframe: From baseline until objective tumor progression, as assessed up to 3 years
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | 76 |
Proportion of Patients Experiencing a Complete Response
"Evaluated according to the International Working Group Response criteria as reported by Cheson et al. and the revised Cheson criteria.~Complete response is defined as complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Typically FDG-avid lymphoma: in patients with PET scan positive before therapy, a posttreatment residual mass of any size is permitted as long as it is PET negative. Variably FDG-avid lymphomas/FDG avidity unknown: in patients with a negative pretreatment PET scan, all lymph nodes and nodal masses must have regressed on CT to normal size (1.5 cm in their greatest transverse diameter for nodes 1.5 cm before therapy). Previously involved nodes that were 1.1 cm to 1.5 cm in their long axis and more than 1)" (NCT01527149)
Timeframe: 22 weeks
| Intervention | Proportion of participants (Number) |
|---|
| Treatment (Monoclonal Antibody and Combination Chemotherapy) | .62 |
Pain Scores
VAS pain scoes at rest 0=no pain, 100=worst pain imaginable (NCT01545700)
Timeframe: Patients were followed for the duration of hospitalization, for an average of 6 days
| Intervention | 0-100 VAS scale scores on a scale (Mean) |
|---|
| Placebo 0-4 Hours | 50 |
| Dexamethasone 4 mg 0-4 Hours | 47 |
| Dexamethasone 8 mg 0-4 Hours | 45 |
| Placebo 8-24 Hours | 50 |
| Dexamethasone 4 mg 8-24 Hours | 45 |
| Dexamethasone 8 mg 8-24 Hours | 44.5 |
Serum Blood Glucose Concentrations
Serum blood glucose concentrations (NCT01545700)
Timeframe: Patient were followed for the duration of hospitalization, for an average of 6 days
| Intervention | mg/dl (Mean) |
|---|
| Placebo 0-4 Hours-baseline | 101 |
| Placebo 0-4 Hours-1 Hour | 137 |
| Placebo 0-4 Hours-2 Hours | 140 |
| Placebo 0-4 Hours-3 Hours | 141 |
| Placebo 0-4 Hours-4 Hours | 139 |
| Dexamethasone 4 mg 0-4 Hours-baseline | 107 |
| Dexamethasone 4 mg 0-4 Hours-1 Hour | 141 |
| Dexamethasone 4 mg 0-4 Hours-2 Hours | 159 |
| Dexamethasone 4 mg 0-4 Hours-3 Hours | 159 |
| Dexamethasone 4 mg 0-4 Hours-4 Hours | 159 |
| Dexamethasone 8 mg 0-4 Hours-baseline | 108 |
| Dexamethasone 8 mg 0-4 Hours-1 Hour | 138 |
| Dexamethasone 8 mg 0-4 Hours-2 Hours | 151 |
| Dexamethasone 8 mg 0-4 Hours-3 Hours | 146 |
| Dexamethasone 8 mg 0-4 Hours-4 Hours | 149 |
| Placebo 8-24 Hours Baseline | 101 |
| Placebo 8-24 Hours-8 Hours | 150 |
| Placebo 8-24 Hours-24 Hours | 121 |
| Dexamethasone 4 mg 8-24 Hours-baseline | 98 |
| Dexamethasone 4 mg 8-24 Hours-8 Hours | 149 |
| Dexamethasone 4 mg 8-24 Hours-24 Hours | 119 |
| Dexamethasone 8 mg 8-24 Hours-baseline | 100 |
| Dexamethasone 8 mg 8-24 Hours-8 Hours | 151 |
| Dexamethasone 8 mg 8-24 Hours-24 Hours | 124 |
Change in the Central Macular Thickness
The primary outcome is the change in the central macular thickness, either an increase or decrease, as measured by optical coherence tomography as compared to the preoperative thickness. (NCT01546402)
Timeframe: Baseline and 6 MONTHS
| Intervention | Microns (Mean) |
|---|
| Phacoemulsification With IOL Implant | 85.67 |
| Phacoemulsification With Ozurdex | -18.22 |
Change in the Visual Acuity
Change in the visual acuity as measured by the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity scale (number of letters at 6 months - number of letters at baseline) The number of letters read on the ETDRS scale will be measured, with 0 being the worst and 35 being the best (NCT01546402)
Timeframe: Difference in number of letters read (6 months minus baseline)
| Intervention | Number of letters on ETDRS scale (Mean) |
|---|
| Phacoemulsification With IOL Implant | 0.11 |
| Phacoemulsification With Ozurdex | 15.22 |
Response to Car-BiRD Treatment.
"The best response for all patients who had at least one dose of drug was measured.~Response categories:~Stringent Complete Response (sCR), Complete Remission(CR), Very Good Partial Remission(VGPR), Partial Remission (PR), Progressive Disease (PD), Stable Disease (SD).~The response is evaluated based on the IMWG criteria." (NCT01559935)
Timeframe: From baseline to best response, up to 116 weeks.
| Intervention | Participants (Count of Participants) |
|---|
| sCR/CR | VGPR | PR | SD | PD | Not Evaluable |
|---|
| Car-BiRD Therapy | 28 | 31 | 11 | 1 | 0 | 1 |
Stem Cells Collection
At the end of the Car Phase, all participants underwent stem cell collection. (NCT01559935)
Timeframe: At the end of the Car Phase, prior to the start of the BiRD Phase, on average after 162 days.
| Intervention | Number of stem cells collected per Kg (Mean) |
|---|
| Car-BiRD Therapy | 12854635 |
Progression Free Survival
Progression was defined using the IMWG criteria. (NCT01559935)
Timeframe: From start of study drug until first incidence of progression, up to 1222 days.
| Intervention | months (Median) |
|---|
| Car-BiRD Therapy | 18.3 |
Event Free Survival
an event is defined by coming off protocol for any reason, including progression of disease, lack of disease response, regimen intolerability, withdrawal of consent or death. (NCT01559935)
Timeframe: From date of study enrollment until the date of removal of study due to progression of disease, toxicity or withdrawal of consent, up to 1222 days.
| Intervention | Days (Median) |
|---|
| Car-BiRD Therapy | 401.5 |
Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 4 Milligram Dose
Number of patients in Phase I cohort 3 experiencing dose-limiting toxicity at the 4 milligram dose for participants within the third dose cohort (NCT01570387)
Timeframe: One month
| Intervention | Participants (Count of Participants) |
|---|
| Pom Plus Dex | 1 |
Response to the Maximal Tolerated Dose
Number of participants with a response to treatment at that maximal tolerated dose (including partial, very good, or complete responses) (NCT01570387)
Timeframe: one year
| Intervention | Participants (Count of Participants) |
|---|
| Pom Plus Dex | 10 |
Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 2 Milligram Dose
Number of patients in Phase I cohort 1 experiencing dose-limiting toxicity at the 2 milligram dose of pomalidomide combined with dexamethasone in subjects with previously- treated light-chain amyloidosis (NCT01570387)
Timeframe: one month
| Intervention | Participants (Count of Participants) |
|---|
| Pom Plus Dex | 0 |
Assessing Dose-limiting Toxicity to Determine Maximal Tolerated Dosage at 3 Milligram Dose
Number of patients in Phase I cohort 2 experiencing dose limiting toxicity in the 3 milligram dose level, cohort 2. (NCT01570387)
Timeframe: One month
| Intervention | Participants (Count of Participants) |
|---|
| Pom Plus Dex | 0 |
NRS (Numerical Rating Scale) Pain Scores
Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable. (NCT01586806)
Timeframe: Postoperative day 1
| Intervention | units on a scale (Median) |
|---|
| Control | 3 |
| Dexamethasone 1 mg | 3 |
| Dexamethasone 4 mg | 2 |
Patient Satisfaction
Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied); (NCT01586806)
Timeframe: Up to 2 days following surgery
| Intervention | units on a scale (Median) |
|---|
| Control | 8 |
| Dexamethasone 1 mg | 8 |
| Dexamethasone 4 mg | 9 |
Postoperative Morphine Consumption
Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge. (NCT01586806)
Timeframe: Up to 2 days following surgery
| Intervention | milligrams (Median) |
|---|
| Control | 45 |
| Dexamethasone 1 mg | 30 |
| Dexamethasone 4 mg | 30 |
Patient-perceived Duration of Analgesia
After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution. (NCT01586806)
Timeframe: Up to 2 days following surgery
| Intervention | hours (Median) |
|---|
| Control | 33 |
| Dexamethasone 1 mg | 41 |
| Dexamethasone 4 mg | 46.5 |
Percentage of Participants With Severe Infusion-site Reactions
The percentages of participants with severe infusion-site reactions, including severe site pain, or severe site redness (erythema) or severe site hardness (induration) are presented. (NCT01594749)
Timeframe: Day 1 through Day 17, inclusive
| Intervention | Percentage of Participants (Number) |
|---|
| Fosaprepitant Regimen | 0.0 |
| Control Regimen | 0.0 |
Percentage of Participants With No Vomiting From 0 to 120 Hours After Initiation of MEC
No Vomiting was defined as no emetic (vomiting) episodes, including no vomiting and no retching or dry heaves (attempts to vomit that are not productive of stomach contents), regardless of use of rescue medication. (NCT01594749)
Timeframe: 0 to 120 hours after initiation of MEC
| Intervention | Percentage of participants (Number) |
|---|
| Fosaprepitant Regimen | 82.7 |
| Control Regimen | 72.9 |
Percentage of Participants With Complete Response From 25 to 120 Hours After Initiation of Moderately Emetogenic Chemotherapy (MEC)
A Complete Response was defined as no vomiting and no use of rescue medication. (NCT01594749)
Timeframe: 25 to 120 hours after initiation of MEC
| Intervention | Percentage of Participants (Number) |
|---|
| Fosaprepitant Regimen | 78.9 |
| Control Regimen | 68.5 |
Percentage of Participants With Complete Response From 0 to 120 Hours After Initiation of MEC
A Complete Response was defined as no vomiting and no use of rescue medication. (NCT01594749)
Timeframe: 0 to 120 hours after initiation of MEC
| Intervention | Percentage of Participants (Number) |
|---|
| Fosaprepitant Regimen | 77.1 |
| Control Regimen | 66.9 |
Percentage of Participants With Complete Response From 0 to 24 Hours After Initiation of MEC
A Complete Response was defined as no vomiting and no use of rescue medication. (NCT01594749)
Timeframe: 0 to 24 hours after initiation of MEC
| Intervention | Percentage of Participants (Number) |
|---|
| Fosaprepitant Regimen | 93.2 |
| Control Regimen | 91.0 |
Percentage of Participants With Infusion-site Thrombophlebitis
The percentages of participants with infusion-site thrombophlebitis are presented. Thrombophlebitis was defined as a condition affecting a superficial vein used for an IV infusion, associated with red color, hardness upon palpation, and the presence of a tender cord and possible fever. (NCT01594749)
Timeframe: Day 1 through Day 17, inclusive
| Intervention | Percentage of Participants (Number) |
|---|
| Fosaprepitant Regimen | 0.6 |
| Control Regimen | 0.0 |
Pain Scores
Patients were asked to rate their pain score during activity on a 11-point scale (0 = no pain to 10 = excruciating pain). (NCT01616173)
Timeframe: 2 weeks
| Intervention | units on a scale (Median) |
|---|
| Perineural Dexamethasone | 2 |
| Intravenous Dexamethasone | 2.5 |
| No Perioperative Steroids | 2 |
Opioid Consumption
Postoperative opioid consumption was converted to equivalent dose of oral morphine at two weeks following surgery. (NCT01616173)
Timeframe: 2 weeks
| Intervention | mg/day (Median) |
|---|
| Perineural Dexamethasone | 0 |
| Intravenous Dexamethasone | 0 |
| No Perioperative Steroids | 0 |
Quality of Recovery
QoR-40 questionnaire instrument consists of 40 questions that examine 5 domains of patient recovery using a 5 point Likert scale: none of the time, some of the time, usually, most of the time and all of the time. The five domains include physical comfort, pain, physical independence, psychological support and emotional state. Global QoR-40 scores range from minimum of 40 to a maximum of 200. The scores are added together to compute a total score. A low score of 40 represents very poor quality of recovery while a high score, i.e. 200 represents outstanding quality of recovery. (NCT01616173)
Timeframe: 2 weeks
| Intervention | units on a scale (Median) |
|---|
| Perineural Dexamethasone | 181 |
| Intravenous Dexamethasone | 184 |
| No Perioperative Steroids | 181 |
Percentage of Participants Who Received Treatment Including Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT01632150)
Timeframe: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
| Intervention | Percentage of participants (Number) |
|---|
| Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide | 62.5 |
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had Grade 3 or Higher Nonhematologic Adverse Events (AEs)
AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or unknown relationship to study drug. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. (NCT01632150)
Timeframe: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
| Intervention | Percentage of participants (Number) |
|---|
| Thalidomide + Elotuzumab + Dexamethasone | 55.0 |
Percentage of All Participants Who Received Treatment Without Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. (NCT01632150)
Timeframe: From the first dose of study drug until the earlier of discontinuation from E-Td or the time when cyclophosphamide was initiated
| Intervention | Percentage of participants (Number) |
|---|
| Thalidomide + Elotuzumab + Dexamethasone | 57.5 |
Percentage of All Participants Who Received Treatment Including Cyclophosphamide and Had 1 Dose Reduction or Discontinued Due to an Adverse Event
Elotuzumab dose reduction was not permitted. Thalidomide dose reduction, delay, interruptions, or discontinuation was permitted in the event of toxicity. Dexamethasone dose reduction was also permitted in the event of toxicity and in the setting of infusion reactions;dose delays were allowed as clinically indicated at the discretion of the investigator. Cyclophosphamide dose reduction, delay, interruption, or discontinuation was permitted in the event of toxicity. (NCT01632150)
Timeframe: From the first dose of study drug until the last dose of treatment, including cyclophosphamide treatment
| Intervention | Percentage of participants (Number) |
|---|
| Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide | 65.0 |
Percentage of Participants With a Complete Response - Overall, Acute, and Delayed Stages
A Complete Response was defined as no vomiting or dry heaves and no use of a rescue therapy. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. (NCT01636947)
Timeframe: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
| Intervention | Percentage of Participants (Number) |
|---|
| Overall Stage | Acute Stage | Delayed Stage |
|---|
| Aprepitant Regimen | 73.4 | 95.8 | 74.3 |
,| Control Regimen | 70.4 | 97.9 | 71.2 |
Percentage of Participants With No Impact on Daily Life - Overall Stage
"The Functional Living Index-Emesis questionnaire (FLIE) is a validated, participant-reported instrument to measure the impact of chemotherapy-induced nausea and vomiting on daily life. There are 9 nausea-related items and 9 vomiting-related items, each on a 7-point scale. For the purposes of this study, No Impact on daily life was defined as an average item score of >6 on the 7-point scale; a total score >108 indicates no impact on daily life. Overall Stage=0 to 120 hours after initiation of MEC." (NCT01636947)
Timeframe: Day 6
| Intervention | Percentage of Participants (Number) |
|---|
| Aprepitant Regimen | 76.8 |
| Control Regimen | 73.8 |
Percentage of Participants With No Vomiting - Acute and Delayed Stages
A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. (NCT01636947)
Timeframe: Day 1, Day 2 to Day 5
| Intervention | Percentage of Participants (Number) |
|---|
| Acute Stage | Delayed Stage |
|---|
| Aprepitant Regimen | 95.8 | 78.5 |
,| Control Regimen | 98.8 | 72.4 |
Number of Emetic Events - Overall Stage
The number of emetic events that occurred during the Overall Stage (0 to 120 hours after initiation of MEC) are presented. (NCT01636947)
Timeframe: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
| Intervention | Number of Emetic Events (Number) |
|---|
| Aprepitant Regimen | 54 |
| Control Regimen | 68 |
Percentage of Participants With No Vomiting and No Significant Nausea - Overall Stage
"Nausea was to be assessed using a 100-mm horizontal visual analogue scale (VAS) located in the participant diary labeled: How much nausea have you had over the last 24 hours? The left end of the scale (0 mm) was labeled no nausea, and the right end of the scale (100 mm) is labeled nausea as bad as it could be. In this study, No Significant Nausea was defined as a VAS nausea rating <25 mm." (NCT01636947)
Timeframe: Days 1 to Day 5
| Intervention | Percentage of Participants (Number) |
|---|
| Aprepitant Regimen | 76.4 |
| Control Regimen | 72.4 |
Percentage of Participants With One or More Clinical Adverse Event
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition, which is temporally associated with the use of the study drug, is also an adverse event. Nausea and vomiting experienced during Days 1-6 were not counted as adverse events unless they were reported as a serious adverse event. (NCT01636947)
Timeframe: Day 1 through Day 29 (Up to 28 days after first dose of study drug)
| Intervention | Percentage of Participants (Number) |
|---|
| Aprepitant Regimen | 56.2 |
| Control Regimen | 53.2 |
The Percentage of Participants With No Vomiting - Overall Stage
A vomiting episode was defined as one or more episodes of emesis (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). No vomiting during the Overall Stage was defined as no episodes of emesis during the 120 hours (Days 1-5) after initiation of moderately emetogenic chemotherapy (MEC). (NCT01636947)
Timeframe: Hour 0 on Day 1 to Day 5 (approximately 120 hours)
| Intervention | Percentage of Participants (Number) |
|---|
| Aprepitant Regimen | 77.2 |
| Control Regimen | 72.0 |
Number of Participants With No Use of a Rescue Therapy - Overall, Acute, and Delayed Stages
The percentage of participants who used no rescue therapy after initiation of MEC is presented for the Overall, Acute and Delayed Stages. Overall Stage=0 to 120 hours after initiation of MEC. Acute Stage=0 to 24 hours after initiation of MEC. Delayed Stage=25 to 120 hours after initiation of MEC. (NCT01636947)
Timeframe: Day 1 to Day 5
| Intervention | Percentage of Participants (Number) |
|---|
| Overall Stage | Acute Stage | Delayed Stage |
|---|
| Aprepitant Regimen | 84.8 | 98.7 | 84.8 |
,| Control Regimen | 87.7 | 99.2 | 88.5 |
Incidence of Postoperative Nausea and Vomiting
incidence of nausea, vomiting and requirement for rescue antiemetics (NCT01639599)
Timeframe: postoperative 24 hours
| Intervention | participants (Number) |
|---|
| Dexamethasone | 21 |
| Dexamethasone, Haloperiol 1mg | 11 |
| Dexamethasone + Haloperidol 2mg | 10 |
Sedation Change in Recovery Room
measurement of sedation change using a visual analogue scale (visual analogue scale; the minimum: 0 = widely awake and the maximum: 10 = maximally asleep) (NCT01639599)
Timeframe: postoperative 30, 60, 90, and 120 min
| Intervention | score on a scale (Mean) |
|---|
| postoperative 30 min | postoperative 60 min | postoperative 90 min | postoperative 120 min |
|---|
| Dexamethasone | 4.6 | 4.4 | 3.5 | 3.0 |
,| Dexamethasone + Haloperidol 2mg | 5.5 | 5.0 | 4.7 | 4.3 |
,| Dexamethasone, Haloperiol 1mg | 4.7 | 4.4 | 4.0 | 3.2 |
Incidence of Extrapyramidal Symptoms
(NCT01639599)
Timeframe: postoperative 24 hours
| Intervention | participants (Number) |
|---|
| Dexamethasone | 0 |
| Dexamethasone, Haloperiol 1mg | 0 |
| Dexamethasone + Haloperidol 2mg | 0 |
Incidence of Cardiac Arrhythmia
cardiac arrhythmia on continuous standard lead EKG monitoring (NCT01639599)
Timeframe: postoperative 2 hours
| Intervention | Participants (Count of Participants) |
|---|
| Dexamethasone | 0 |
| Dexamethasone, Haloperiol 1mg | 0 |
| Dexamethasone + Haloperidol 2mg | 0 |
Progression-free Survival
"From date of registration to date of first documentation of progression or death due to any cause.~Per the International Uniform Response Criteria for Multiple Myeloma, progression is defined as >=1 of Serum M protein increase >= 25% from lowest response level, with an absolute increase of >= 0.5g/dL; Urine M protein increase >= 25% from lowest response level, with an absolute increase of >= 200 mg/24 hrs; If participant had serum M protein <1 g/dL, urine M protein <200 mg/24 hrs, and an involved serum free light chain level >= 10mg/dL at baseline: >= 25% increase in the difference between involved and uninvolved serum free light chain level with an absolute increase of >= 10 mg/dL; Bone marrow plasma cell % increase =25% from baseline with the absolute plasma cell % >=10%; New bone lesions or soft tissue plasmocytomas, or definite increase in size of existing bone lesions or soft tissue plasmocytomas; Development of hypercalcemia that can be attributed solely to multiple myeloma" (NCT01668719)
Timeframe: Up to 6 years post registration
| Intervention | months (Median) |
|---|
| Arm I (Bortezomib, Lenalidomide, Dexamethasone) | 33.6 |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | 31.5 |
Response (Partial Response [PR] or Better) Rate
Percentage of participants with PR or better to treatment per the International Uniform Response Criteria for Multiple Myeloma stringent Complete Response- CR criteria + normal serum free light chain (FLC) ratio + absence of clonal cells in bone marrow (BM) by immunohistochemistry or immunofluorescence CR- Negative immunofixation (IFX) on serum & urine M proteins + <5% plasma cells in BM + disappearance of soft tissue plasmocytomas (STP) very good PR- PR criteria + serum & urine M proteins detectable by IFX but not on electrophoresis or >=90% reduction (RED) in serum M protein & urine M protein <100 g/24 hrs PR- >=50% RED in size of STP, if present at baseline & >=50% RED in plasma cells, if >=30% plasma cells in BM at baseline: & RED in serum M protein of >=50% & in urine M protein of >= 90% or to 200 mg/24hr OR if serum M protein <1 g/dL, urine M protein <200 mg/24 hrs, & involved serum FLC level >= 10 mg/dl at baseline: >= 50% RED in (involved-uninvolved) serum FLC levels (NCT01668719)
Timeframe: Up to 6 years post registration
| Intervention | Percentage of participants (Number) |
|---|
| Arm I (Bortezomib, Lenalidomide, Dexamethasone) | 88 |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | 83 |
Overall Survival
From date of registration to date of death due to any cause (NCT01668719)
Timeframe: Up to 6 years post registration
| Intervention | months (Median) |
|---|
| Arm I (Bortezomib, Lenalidomide, Dexamethasone) | NA |
| Arm II (Bortezomib, Lenalidomide, Dexamethasone, Elotuzumab) | 68 |
Phase I: Maximum Tolerated Dose (MTD) of Elotuzumab in Combination With Bortezomib, Lenalidomide and Dexamethasone
"Assess safety of elotuzumab in combination with bortezomib, lenalidomide and dexamethasone and select the optimal dose of elotuzumab for the Phase II portion from 10mg/kg on each cycle, to 5mg/kg on each cycle MTD reflects the highest dose that had a dose-limiting toxicity (DLT) rate of ≤ 1/6 participants. DLTs were defined as treatment regimen related: grade ≥ 3 non-hematologic toxicity; grade 3 nausea or diarrhea despite anti-emetic and anti-diarrheal therapy; grade 3 hyperglycemia if symptomatic or glucose level > 300mg/ml despite insulin and/or oral diabetic therapy; grade 4 neutropenia ≥ 7 days or grade 3/4 neutropenia with fever (≥ 38.5 oC); grade 4 thrombocytopenia ≥ 7 days or associated with hemorrhage; delay of treatment with any agent by > 2 weeks due to drug related toxicity.~DLT were graded using the NCI CTCAE version 4.0~Note:~i) the second, lower dose level was not tested as the first dose level was deemed safe ii) 6 participants were evaluable at phase I analysis" (NCT01668719)
Timeframe: time from first participants randomized until at least 6 patients were evaluable for DLTs. DLTs were assessed only during Cycle 1 (21 days)
| Intervention | mg/kg (Phase II dosing for elotuzumab) (Number) |
|---|
| Phase I Dose Level 1 (Elotuzumab, 10mg, and Bortezomib, Lenalidomide and Dexamethasone) | 10 |
Maximum Tolerated Dose of the Combination of ASP7487 (OSI-906) With Velcade and Dexamethasone
"Phase 1: To determine the maximum tolerated dose (MTD) of ASP7487 (OSI-906) administered in combination with the recommended dose and schedule of bortezomib and dexamethasone;~Phase 2: To evaluate the antitumor activity of ASP7487 (OSI-906) in combination with bortezomib and dexamethasone at the MTD established from the Phase 1 component." (NCT01672736)
Timeframe: 45 months
| Intervention | milligrams (Number) |
|---|
| Linsitinib starting dose in milligrams | Linsitinib maximum dose in milligrams |
|---|
| ASP7487, Velcade, Dexamethasone | 75 | 150 |
Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation
VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain). Change = (Day 22 score -- baseline score). (NCT01702233)
Timeframe: Baseline to Day 22
| Intervention | units on a scale (mm) (Mean) |
|---|
| Traumeel S Inj. | -18.7 |
| Fortecortin/Dexamethasone 8 mg Inj | -27.2 |
Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Fortecortin at Visit 7 (Day 105)
VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain). (NCT01702233)
Timeframe: Baseline vs. day 105
| Intervention | units on a scale, mm (Mean) |
|---|
| Traumeel S Inj. | -32.2 |
| Fortecortin/Dexamethasone 8 mg Inj | -33.3 |
Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 5 (Day 22)
VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain). (NCT01702233)
Timeframe: Baseline vs. Day 22
| Intervention | Change in mm baseline vs. day 22 (Mean) |
|---|
| Traumeel S Inj. | -18.7 |
| Saline Inj | -17.1 |
Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 7 (Day 105)
VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain). (NCT01702233)
Timeframe: Baseline vs. Day 105
| Intervention | units on a scale, mm (Mean) |
|---|
| Traumeel S Inj. | -32.2 |
| Saline Inj | -30.1 |
Change From Baseline in DASH at Visit 5 (Day 22)
"The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy.~The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from no difficulty (value 1) to unable (value 5).~The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers." (NCT01702233)
Timeframe: Baseline vs. Day 22
| Intervention | DASH score (Mean) |
|---|
| Traumeel S Inj. | -11.00 |
| Fortecortin/Dexamethasone 8 mg Inj | -18.03 |
| Saline Inj. | -12.59 |
Change From Baseline in DASH at Visit 7 (Day 105)
"The score from the questions answered on the DASH (Disaability of the Arm, Shoulder and Hand) questionnaire were evaluated on both shoulders at screening and on the The score consists of a basic questionnaire of 30 questions regarding the daily activities with the answer options from no difficulty (value 1) to unable (value 5).~The calculation is: ((sum of values of responses/number of responses)-1) X 25. Best possible result is 0, worst possible result is 100. The score may not be calculated if there are more than 3 missing answers.target shoulder at the later visits. Any changes between the score from baseline was used to evaluate efficacy" (NCT01702233)
Timeframe: Baseline vs. Day 105
| Intervention | DASH score (Mean) |
|---|
| Traumeel S Inj. | -20.91 |
| Fortecortin/Dexamethasone 8 mg Inj | -22.07 |
| Saline Inj. | -19.77 |
Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22) Traumeel vs Fortecortin
Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. (NCT01702233)
Timeframe: Baseline vs. Day 22
| Intervention | degrees (Mean) |
|---|
| Traumeel S Inj. | 11.3 |
| Fortecortin/Dexamethasone 8 mg Inj | 17.2 |
Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo
Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. (NCT01702233)
Timeframe: Baseline vs. Day 22
| Intervention | degrees (Mean) |
|---|
| Traumeel S Inj. | 11.3 |
| Saline Inj | 13.5 |
Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Fortecortin
Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. (NCT01702233)
Timeframe: Baseline vs. Day 105
| Intervention | degrees (Mean) |
|---|
| Traumeel S Inj. | 13.9 |
| Fortecortin/Dexamethasone 8 mg Inj | 17.3 |
Painful Arc Test at Visit 5 (Day 22)
The amount of pain that disappeared by further abduction in the range between 60° and 120° was to be measured, with measurement of pain being positive/negative. The idea behind the test is the subacromial space in abduction becomes smaller, whereby compression of the rotator cuff and the subacromial bursa occurs (impingement test). (NCT01702233)
Timeframe: Baseline vs. day 22
| Intervention | participants (Number) |
|---|
| Traumeel S Inj. | 29 |
| Fortecortin/Dexamethasone 8 mg Inj | 30 |
| Saline Inj. | 12 |
Jobe Test at Visit 5 (Day 22) With Measurement of Weakness
This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician's attempts to depress the upper arm to look for muscle weakness. (NCT01702233)
Timeframe: Baseline vs. day 22
| Intervention | participants (Number) |
|---|
| Traumeel S Inj. | 19 |
| Fortecortin/Dexamethasone 8 mg Inj | 19 |
| Saline Inj. | 6 |
Jobe Test at Visit 5 (Day 15) With Measurement of Pain
This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician's attempts to depress the upper arm to look for muscle weakness. (NCT01702233)
Timeframe: Baseline vs. Day 22
| Intervention | participants (Number) |
|---|
| Traumeel S Inj. | 29 |
| Fortecortin/Dexamethasone 8 mg Inj | 27 |
| Saline Inj. | 10 |
Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo
Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees. (NCT01702233)
Timeframe: Baseline vs. day 105
| Intervention | degrees (Mean) |
|---|
| Traumeel S Inj. | 13.9 |
| Saline Inj | 20.0 |
Pain Visual Analogue Scale (VAS) Score Measured at 10-point Scale
"Visual Analog Scale (VAS) is a 0-10 scale for patients to indicate intensity level of pain with 0 indicating No pain and 10 indicating Worst possible, unbearable, excruciating pain. A descriptive time plot of VAS scores will be produced for all enrolled subjects, with loess curve fitted separately for the experimental and control groups. A linear mixed effects model will be used to compare the pain VAS scores between the experimental and control groups." (NCT01748942)
Timeframe: 21 days
| Intervention | units on a scale (Mean) |
|---|
| Postoperative day #1 | Postoperative day #2 | Postoperative day #3 | Postoperative day #7-21 |
|---|
| Arm I (Treatment) | 7.4 | 6.0 | 5.3 | 3.0 |
,| Arm II (Control) | 6.8 | 6.4 | 6.7 | 2.5 |
Opioid Use
(NCT01748942)
Timeframe: 3 days
| Intervention | mg of oxycodone equivalent (Mean) |
|---|
| Arm I (Treatment) | 137.1 |
| Arm II (Control) | 147.3 |
Length of Hospital Stay (Number of Days Between the Date of Surgery and Date of Discharge)
Kaplan-Meier functions will be fitted to compare the length of hospital stay between the experimental and control groups. (NCT01748942)
Timeframe: Up to 21 days
| Intervention | days (Median) |
|---|
| Arm I (Treatment) | 5 |
| Arm II (Control) | 4 |
Days With Feeding Tube
(NCT01748942)
Timeframe: 12 months
| Intervention | days (Median) |
|---|
| Arm I (Treatment) | 4 |
| Arm II (Control) | 11 |
PSS Normalcy of Diet
"Performance Status Score (PSS) - Normalcy of Diet score is a 0-100 scale that measures diet restrictions with 0= Non-oral feeding (tube fed) and 100 = Full diet (no restrictions)" (NCT01748942)
Timeframe: 30 days
| Intervention | units on a scale (Mean) |
|---|
| Arm I (Treatment) | 51.7 |
| Arm II (Control) | 36.7 |
UM-QOL Eating
"The University of Michigan Head and Neck Quality of Life Questionnaire (UM-QOL) is 20 item, 1-5 scale, questionnaire that measures how much the patient has been bothered during various activities as a result of head and neck condition or treatment in the past four weeks with 1= Not at all and 5=Extremely. The scores are calculated using a Likert Scale, which transforms the 1-5 choices into a 0-100 scale with 100 being normal and 0 being poor quality of life. This test contains separate domains (eating, etc.) that can be scored independently. Scores were analyzed between cohorts pre and post operatively." (NCT01748942)
Timeframe: 21 days
| Intervention | units on a scale (Mean) |
|---|
| Arm I (Treatment) | 59.3 |
| Arm II (Control) | 60.1 |
Number of Participants With Adverse Events, Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Recorded and reported for each patient, and frequency tables will be reviewed to determine adverse event patterns. These results are reported in the Adverse Events section of this CT.gov report. (NCT01794039)
Timeframe: Up to 30 days after last day of study drug treatment
| Intervention | Participants (Count of Participants) |
|---|
| Arm A (Lenalidomide, Dexamethasone) | 5 |
| Arm B (Pomalidomide, Dexamethasone) | 4 |
Overall Survival
The distribution of survival time will be estimated using the method of Kaplan-Meier. Due to an early closer from slow accrual the data from both arms was combined in survival analysis. (NCT01794039)
Timeframe: Time from registration to death due to any cause, assessed up to 2 years
| Intervention | Months (Median) |
|---|
| Arms A and B | 13.4 |
Time to Progression
The distribution of time to progression will be estimated using the method of Kaplan-Meier. The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy. (NCT01794039)
Timeframe: Time from registration to the earliest date with documentation of disease progression, assessed up to 2 years
| Intervention | Months (Median) |
|---|
| Arms A and B | 10 |
Proportion of Confirmed Tumor Responses Defined to be a Partial Response or Better Noted as the Objective Status on Two Consecutive Evaluations
The proportion of successes will be estimated in each arm independently by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. A confirmed tumor response is defined to be a partial response or better noted as the objective status on two consecutive evaluations while receiving lenalidomide and dexmethasone (Arm A) or pomalidomide and dexamethasone (Arm B). All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response.The International Myeloma Working Group (IMWG) uniform response criteria (Rajkumar et al, 2011) will be used to assess response to therapy. (NCT01794039)
Timeframe: Up to 2 years
| Intervention | proportion of participants (Number) |
|---|
| Arm A (Lenalidomide, Dexamethasone) | .4 |
| Arm B (Pomalidomide, Dexamethasone) | .25 |
Maximum Tolerated (MTD) Dose of Cyclophosphamide (Phase I)
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. (NCT01864018)
Timeframe: At 28 days
| Intervention | mg/m² weekly (Number) |
|---|
| Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 400 |
Rate of Complete Response, Very Good Partial Response, or Partial Response (Phase II, Cohort B)
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated. (NCT01864018)
Timeframe: Up to 48 weeks
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 63 |
Survival Time
The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT01864018)
Timeframe: Time from registration to death due to any cause, assessed up to 5 years
| Intervention | months (Median) |
|---|
| Phase I/II, Cohort A | NA |
| Phase II, Cohort B | NA |
Maximum Tolerated (MTD) Dose of Cyclophosphamide With Ixazomib and Dexamethasone (Phase I)
Will be defined as the dose level below the lowest dose that induces dose-limiting toxicity in at least 1/3 of patients, as assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. (NCT01864018)
Timeframe: At 28 days
| Intervention | mg weekly (Number) |
|---|
| MTD of ixazomib | MTD of dexamethasone |
|---|
| Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 4 | 40 |
Progression-free Survival (PFS)
The distribution of PFS will be estimated using the method of Kaplan Meier. (NCT01864018)
Timeframe: Time from registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 5 years
| Intervention | months (Median) |
|---|
| Phase I/II, Cohort A | NA |
| Phase II, Cohort B | NA |
Percentage of Patients With Complete Response or Very Good Partial Response (Phase II, Cohort A)
The percentage of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated. (NCT01864018)
Timeframe: Up to 48 weeks
| Intervention | percentage of participants (Number) |
|---|
| Treatment (Ixazomib Citrate, Cyclophosphamide, Dexamethasone) | 35 |
Percent of Bone Marrow-Derived Multiple Myeloma (MM) Cells Expressing Cell Surface CS1 at Time of Progression
"CS1 (CD2 subset-1, also known as CRACC, SLAMF7, CD319) expression levels in multiple myeloma cells were analyzed from bone-marrow aspirates collected at time of progression.~The following conditions were considered to describe multiple myeloma cells expressing CS1 (CS1+/CD38++/CD138+/CD56+/CD19-/CD45DIM)" (NCT01891643)
Timeframe: Time of progression (up to approximately 54 months from pre-treatment screening)
| Intervention | Percent of cells expressing CS1 (Median) |
|---|
| E-Ld Cohort | 46.59 |
| Ld Cohort | 84.62 |
Overall Survival Crossover Group
Assessed in the crossover arm using the method of Kaplan Meier. (NCT01903811)
Timeframe: From date of crossover to date of death due to any cause, assessed up to 3 years from randomization
| Intervention | months (Median) |
|---|
| Crossover Arm | 15 |
Progression-free Survival
Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified long-rank test. Progression is defined using the International Uniform Response Criteria for Multiple Myeloma as new or increase in size of existing bone lesions or soft tissue plasmacytomas; or development of hypercalcemia attributable solely to MM; or ≥ 25% increase from baseline or lowest response level of either serum M protein, urine M protein, difference in involved & uninvolved serum free light chain level or bone marrow plasma cell percentage. (NCT01903811)
Timeframe: From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 2 years
| Intervention | months (Median) |
|---|
| Arm I (Dexamethasone, Low-dose Carfilzomib) | 5 |
| Arm II (Dexamethasone, High-dose Carfilzomib) | 8 |
Progression-free Survival of Crossover Group
Assessed in the crossover arm using the method of Kaplan Meier. Progression is defined using the International Uniform Response Criteria for Multiple Myeloma as new or increase in size of existing bone lesions or soft tissue plasmacytomas; or development of hypercalcemia attributable solely to MM; or ≥ 25% increase from baseline or lowest response level of either serum M protein, urine M protein, difference in involved & uninvolved serum free light chain level or bone marrow plasma cell percentage. (NCT01903811)
Timeframe: From date of crossover to date of subsequent documentation of progression or symptomatic deterioration, or death due to any cause, assessed up to 3 years from randomization
| Intervention | months (Median) |
|---|
| Arm III (Crossover Group) | 3 |
Overall Survival
Assessed in each arm using the method of Kaplan Meier and compared between arms using the stratified log-rank test. (NCT01903811)
Timeframe: From date of registration to date of death due to any cause, assessed up to 3 years
| Intervention | months (Median) |
|---|
| Arm I (Dexamethasone, Low-dose Carfilzomib) | 26 |
| Arm II (Dexamethasone, High-dose Carfilzomib) | 22 |
Best Overall Response - Partial Response (PR), Very Good Partial Response (VGPR), Unconfirmed PR (uPR), Stable Disease (SD) Progression (PROG)
Per International Uniform Response Criteria for Multiple Myeloma PR- ≥ 50% reduction in size of soft tissue plasmacytomas & plasma cells; ≥ 50% decrease in serum & reduction in urine M protein ≥ 90% or to < 200 mg/24hr or ≥ 50% decrease in difference in uninvolved & involved serum free light chain levels; VGPR- PR + Serum and urine M proteins detectable by immunofixation but not on electrophoresis or ≥ 90% reduction in serum M protein & urine M protein < 100 mg/24 hrs; uPR- 1 objective status of PR, but confirmation studies are not done, or do not meet the requirements necessary to confirm response; SD- does not meet criteria for sCR, CR, VGPR, PR or PROG; PROG- new or increase in size of existing bone lesions or soft tissue plasmacytomas/ development of hypercalcemia attributable solely to MM/ ≥ 25% increase from baseline/ lowest response level of either serum or Urine M protein, difference in involved & uninvolved serum free light chain level or bone marrow plasma cell percentage. (NCT01903811)
Timeframe: From date of registration to date of best response while on study treatment
| Intervention | Participants (Count of Participants) |
|---|
| Very Good Partial Response (VGPR) | Partial Response (PR) | Unconfirmed Partial Response (uPR) | Stable Disease (SD) | Progressive Disease |
|---|
| Arm I (Dexamethasone, Low-dose Carfilzomib) | 5 | 18 | 0 | 24 | 12 |
,| Arm II (Dexamethasone, High-dose Carfilzomib) | 14 | 11 | 2 | 19 | 7 |
Number of Participants With Progression-free Survival
(NCT01946152)
Timeframe: Up to 6 years
| Intervention | Participants (Count of Participants) |
|---|
| Maximum Tolerated Dosage (MTD) | 3 |
Maximum Tolerated Dose (MTD) (Phase I)
Safety and tolerability will be assessed by clinical review of all relevant parameters, including dose limiting toxicities. Toxicity type and severity will be summarized by frequency tables. Maximum tolerated dose defined as the highest dose level in which patients have been treated with less than 2 instances of dose-limiting toxicity (Phase I) (NCT01946152)
Timeframe: 28 days
| Intervention | mg (Number) |
|---|
| Maximum Tolerated Dose (MTD) | 5 |
Number of Participants Recommended Phase II Dose of Pomalidomide and Dexamethasone, When Both Agents Are Administered Together With Granulocyte-colony Stimulating Factor (Filgrastim) (Phase I)
(NCT01946152)
Timeframe: Up to 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Maximum Tolerated Dose (MTD) | 8 |
Event Free Survival (EFS)
The Kaplan-Meier method will be used to estimate the 2-year EFS for each of the treatment regimens. (NCT01979536)
Timeframe: Time from study entry until progressive disease, relapse, or death, assessed up to 2 years
| Intervention | Percentage of patients (Number) |
|---|
| Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 78.8 |
| Arm CZ (Crizotinib, Combination Chemotherapy) | 76.8 |
Occurrence of Grade 3+ Non-hematologic Adverse Events
Will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicities will be summarized by individual toxicity counts separated by arm. (NCT01979536)
Timeframe: Up to 60 months
| Intervention | Percentage of patients (Number) |
|---|
| Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 80.6 |
| Arm CZ (Crizotinib, Combination Chemotherapy) | 87.9 |
Prognostic Significance of Minimal Residual Disease
Analyzed by estimating the 2-year EFS of negative MRD and positive MRD by arm. Minimal disease was performed using serial assessments of the t(2;5)(p23;q35) NPM-ALK fusion transcript using quantitative RT-PCR. Quantitative RT-PCR was performed by extracting total RNA from peripheral blood specimens. Peripheral blood samples were obtained at baseline, on day 1 of cycle 1, and on day 1 of cycle 2. The normalized copy numbers (NCN) were expressed as copy numbers of NPM-ALK per 104 copies of ABL. Minimal disease (MDD) was defined as >10 NCN at baseline. (NCT01979536)
Timeframe: Baseline up to progressive disease, relapse, or death, assessed up to 2 years
| Intervention | Percentage of patients (Number) |
|---|
| MRD Negative Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 89 |
| MRD Positive Arm BV (Brentuximab Vedotin, Combination Chemotherapy) | 52.6 |
| MRD Negative Arm CZ (Crizotinib, Combination Chemotherapy) | 85.6 |
| MRD Positive Arm CZ (Crizotinib, Combination Chemotherapy) | 58.1 |
Number of Participants With Adrenal Insufficiency
Adrenal insufficiency was defined by a 30 or 60 min cortisol < 18 during a cosyntropin stimulation test (NCT02084134)
Timeframe: 6 weeks following surgery
| Intervention | Participants (Count of Participants) |
|---|
| Steroid Treatment Arm | 2 |
| Non-steroid Treatment | 1 |
Percentage of Patients Discharged on Glucocorticoids
Patient charts were reviewed to identify patients who were discharged on prednisone (NCT02084134)
Timeframe: 1 day (Day of hospital discharge)
| Intervention | Participants (Count of Participants) |
|---|
| Steroid Treatment Arm | 8 |
| Non-steroid Treatment | 2 |
Overall Survival (OS) of HR and IR Relapse Patients
OS rates of HR and IR relapse B-ALL patients who are randomized following Induction Block 1 chemotherapy to receive either two intensive chemotherapy blocks or two 5-week blocks of blinatumomab (HR/IR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Two-year OS estimates will be calculated from date of randomization for both Arm A and Arm B. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 2 years from date of randomization
| Intervention | percentage of participants (Number) |
|---|
| Arm A (HR and IR Control) | 58.40 |
| Arm B (HR and IR Blinatumomab) | 71.33 |
Overall Survival (OS) of LR Relapse Patients
OS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). OS is calculated as the time from randomization to date of death or date of last contact. Three-year OS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 3 years from date of randomization
| Intervention | percentage of participants (Number) |
|---|
| Arm C (LR Control) | 88.29 |
| Arm D (LR Blinatumomab) | 90.37 |
Disease Free Survival (DFS) of Low Risk (LR) Relapse Patients
DFS rates of LR relapse B-ALL patients who are randomized following Block 1 chemotherapy to receive either chemotherapy alone or chemotherapy plus blinatumomab (LR Randomization). DFS is calculated as the time from randomization to date of first event (relapse, second malignancy, remission death) or date of last contact. Three-year DFS estimates will be calculated from date of randomization for both Arm C and Arm D. Two-sided 95% confidence intervals will be calculated. (NCT02101853)
Timeframe: Up to 3 years from date of randomization
| Intervention | percentage of participants (Number) |
|---|
| Arm C (LR Control) | 58.94 |
| Arm D (LR Blinatumomab) | 67.00 |
Toxicity Rates Associated With Modified Standard Therapy, Including Dexamethasone and Additional Pegaspargase
Percentage of patients who experienced Grade 3 or higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (NCT02112916)
Timeframe: 3 years from start of therapy by patient
| Intervention | Percentage of participants (Number) |
|---|
| Total Patients | 78.0 |
Event-free Survival (EFS) for Modified Augmented Berlin-Frankfurt-Munster Backbone With or Without Bortezomib in All Randomized Patients
EFS is calculated as time from randomization at study entry to first event (induction failure, induction death, relapse, second malignancy, remission death) or date of last contact. Three-year EFS rates will be calculated for both groups. (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| Arm A (Combination Chemotherapy) | 81.7 |
| Arm B (Combination Chemotherapy, Bortezomib) | 85.1 |
Cumulative Incidence Rates of Isolated Central Nervous System (CNS) Relapse for SR and IR T-ALL Patients on the Non-bortezomib Containing Arm on This Study (no CRT) and Similar Patients on AALL0434 (Receive CRT)
Cumulative incidence of isolated CNS relapse adjusting for competing risks using the method of: Gray R, A class of K-sample tests for comparing the cumulative incidence of a competing risk. Ann Stat 1141:1154, 1988 (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| Isolated CNS Relapse | Isolated Bone Marrow Relapse | Combined Bone Marrow Relapse |
|---|
| AALL0434 T-ALL Patients | 2.2 | 3.0 | 1.8 |
,| AALL1231 T-ALL Patients | 3.6 | 1.4 | 1.3 |
EFS for Very High Risk (VHR) T-LLy Patients Treated With HR Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Have Complete or Partial Remission and Those Who do Not Respond
EFS for very high risk (VHR) T-LLy patients treated with HR Berlin-Frankfurt-Munster (BFM) intensification blocks who have complete or partial remission and those who do not respond (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| VHR T-LLy (CR/PR) | 0 |
EFS for Very High Risk (VHR) T-ALL Patients Treated With High Risk (HR) Berlin-Frankfurt-Munster (BFM) Intensification Blocks Who Become Minimal Residual Disease (MRD) Negative and Those Who Remain MRD Positive at the End of HR Block 3
EFS will be calculated as time from the end of the three high-risk blocks of therapy to first event (relapse, second malignancy, remission death) or date of last contact. (NCT02112916)
Timeframe: 3 years
| Intervention | Percentage of participants (Number) |
|---|
| VHR T-ALL MRD Undetectable | 25.0 |
| VHR T-ALL MRD Detectable | 88.9 |
The Remission Rate for Participants With High-risk Myeloma
Toward improving the clinical outcomes of research subjects with high-risk MM (HR-MM) in the context of the immediately preceding TT5 trial 2008-02 and TT3 trials 2003-33 and 2006-66, TT5B will attempt to accelerate and sustain, at 2 years from starting therapy, the proportion of subjects in complete remission (AS-CR-2) by reducing host-imposed toxicity and thus facilitating timely completion of highly synergistic 8-drug combination therapy, including the next generation proteasome inhibitor, Carfilzomib (CFZ). This will result in avoiding MM re-growth that, we postulate, ensued in TT3 during recovery phases from severe de-conditioning. Furthermore, we speculate that the incidence of positive minimal residual disease (MRD) will be reduced with the addition of one cycle of consolidation therapy. (NCT02128230)
Timeframe: from baseline to either death or study completion for each subject (up to approximately 48 months)
| Intervention | Participants (Number) |
|---|
| Total Therapy 5B | 0 |
Duration of the Sensorial Supraclavicular Block
Duration of sensorial block defined as the time interval between subject admitted to the Post-Anesthesia Care Unit and the time the first pain medication taken at home (NCT02151487)
Timeframe: within 24-hr after surgery
| Intervention | hour (Mean) |
|---|
| Ropivacaine | 13.4 |
| Ropivacaine and Dexamethasone | 14 |
| Ropivacaine and Clonidine | 17.4 |
| Ropivacaine, Dexamethasone and Clonidine | 18.8 |
Postoperative Analgesia
Post-operative Visual Analog Pain (VAS) scores on the scale of 10 (0=no pain and 10=worse imaginary pain). (NCT02151487)
Timeframe: within 15 minutes at postanesthesia care unit (PACU) arrival
| Intervention | score on a scale of 10 (Median) |
|---|
| Ropivacaine | 0 |
| Ropivacaine and Dexamethasone | 0 |
| Ropivacaine and Clonidine | 0 |
| Ropivacaine, Dexamethasone and Clonidine | 0 |
Reported Side Effects Experienced by Participants
The investigators will determine during phone follow up if patient experienced any side effects related to the Dexamethasone, including vomiting, mood swings, behavior changes, appetite changes, sweating or headache. (NCT02192827)
Timeframe: 5 days
| Intervention | Participants (Count of Participants) |
|---|
| No side effects | Decreased Appetite | Difficulty Sleeping | Mood swings/Agitation | Headache | Other | Multiple |
|---|
| Single Dose Dexamethasone | 71 | 4 | 9 | 7 | 3 | 5 | 17 |
,| Two Dose Dexamethasone | 83 | 7 | 0 | 3 | 1 | 4 | 18 |
Reported Number of Days Until Symptom Resolution
Will determine number of days to symptom resolution, including missed school days. (NCT02192827)
Timeframe: 5 days
| Intervention | Days (Mean) |
|---|
| Single Dose Dexamethasone | 2.4 |
| Two Dose Dexamethasone | 2.5 |
Number of Participants Returning to Care Following Discharge From the Emergency Department
The investigators will determine if each patient had any unscheduled visits to the emergency room, urgent care or primary care physician. (NCT02192827)
Timeframe: 5 days
| Intervention | Participants (Count of Participants) |
|---|
| Single Dose Dexamethasone | 14 |
| Two Dose Dexamethasone | 12 |
Number of Participants With Microbiological Cure (MC)
The secondary efficacy endpoint was the microbiological cure of AOE, defined as the proportion of subjects with microbiological cure at the TOC Visit. Subjects with AOE in both ears were considered to have achieved microbiological cure if microbiological cure was achieved in both ears. (NCT02216071)
Timeframe: 7 days after the completion of therapy; at Day 15 (+/- 1 day)
| Intervention | Participants (Count of Participants) |
|---|
| Ciprodex®, RLD | 115 |
| EXL CDOS | 117 |
Number of Participants With Adverse Events
"Safety outcomes evaluated~AEs" (NCT02216071)
Timeframe: Each monitoring visit through 15 +/- 1 days
| Intervention | Participants (Count of Participants) |
|---|
| Ciprodex®, RLD | 60 |
| EXL CDOS | 67 |
Number of Participants With Clinical Cure of AOE
The primary efficacy endpoint was the clinical cure of AOE, defined as the proportion of subjects with a clinical AOE score of 0 at the TOC Visit. Subjects with AOE in both ears were considered to have achieved clinical cure of AOE if the clinical AOE score was 0 for both ears. The clinical AOE score was defined as the sum of scores for inflammation and edema (0=absent, 1=mild, 2=moderate, 3=severe) and tenderness and otorrhea (0=absent, 1=present). (NCT02216071)
Timeframe: 7 days after the completion of therapy; at Day 15 (+/- 1 day)
| Intervention | Participants (Count of Participants) |
|---|
| Ciprodex®, RLD | 190 |
| EXL CDOS | 191 |
Pain Score
"Post-operative pain was assessed using the well-standardized and accepted visual analog pain scale. The scale shows a series of faces ranging from a happy face at 0= No hurt, to a crying face at 10= Hurts worst. The participant was asked to choose the face that best describes their level of pain. Higher scores indicate higher intensities of pain." (NCT02219581)
Timeframe: Baseline, end of hospital stay (up to 3 days), 1, 4, and 12 months post-operatively
| Intervention | units on a scale (Number) |
|---|
| Baseline | End of hospital stay (up to 3 days post-operative) | 1 month post-operative | 4 months post-operative | 12 months post-operative |
|---|
| Dexamethasone 20 mg | 3 | 0 | 0 | 3 | 0 |
Range of Motion (ROM)
Maximum passive ROM allowed by the patient will be measured using a goniometer. The ROM measurement is the amount of flexion and extension recorded in degrees. An increased ROM is indicative of better joint mobility. (NCT02219581)
Timeframe: Baseline, 1 day post-operatively, 1, 4, and 12 months post-operatively
| Intervention | degrees (Number) |
|---|
| Baseline | 1 Day Post-Operative | 1 Month Post-Operative | 4 Months Post-Operative | 12 Months Post-Operative |
|---|
| Dexamethasone 20 mg | 125 | 105 | 135 | 140 | 110 |
Antiemetic Dose Administered
Post-operative nausea and/or vomiting was assessed by the use of the antiemetic Zofran, which was administered as-needed. (NCT02219581)
Timeframe: Post-operative Days 1 and 2
| Intervention | milligrams (mg) (Number) |
|---|
| Post-operative Day 1 | Post-operative Day 2 |
|---|
| Dexamethasone 20 mg | 4 | 0 |
Blood Glucose
To assess postoperative glucose levels after steroid administration, blood glucose level will be analyzed using a HemoCue testing system. Diabetes is indicated with a random blood glucose measurement of greater than 200 milligrams per deciliter (mg/dL). (NCT02219581)
Timeframe: Baseline, Post-operative Day 1
| Intervention | mg/dL (Number) |
|---|
| Baseline | Post-operative Day 1 |
|---|
| Dexamethasone 20 mg | 100 | 88 |
Post-operative Day of Physical Therapy Clearance
The post-operative day when the participant was cleared by the physical therapy staff to go home was recorded. A shorter clearance time is indicative of better joint function. (NCT02219581)
Timeframe: Up to 3 days post-operatively
| Intervention | days (Number) |
|---|
| Dexamethasone 20 mg | 3 |
Length of Hospital Stay
The length of hospital stay in days is reported here. A higher number of days in the hospital indicates slower recovery. (NCT02219581)
Timeframe: Up to 3 days post-operatively
| Intervention | days (Number) |
|---|
| Dexamethasone 20 mg | 3 |
Number of Participants Readmitted to the Hospital
The number of participants with hospital readmissions after being discharged were recorded. (NCT02219581)
Timeframe: Up to 12 months post-operatively
| Intervention | Participants (Count of Participants) |
|---|
| Dexamethasone 20 mg | 0 |
Number of Participants With Wound Infections
The number of participants with the clinical presence of wound drainage and periprosthetic infection were recorded. (NCT02219581)
Timeframe: Up to 12 months post-operatively
| Intervention | Participants (Count of Participants) |
|---|
| Dexamethasone 20 mg | 0 |
Opioid Analgesic Usage
The amount of post-operative opioid analgesic usage is assessed as Oral Morphine Equivalents (OME) which is the amount of an oral morphine drug that would be necessary to equal the pain treatment from opioid morphine. (NCT02219581)
Timeframe: 1 day post-operatively
| Intervention | Oral Morphine Equivalents (OME) (Number) |
|---|
| Dexamethasone 20 mg | 37.5 |
Patient Satisfaction
Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction (NCT02226159)
Timeframe: 4 weeks
| Intervention | score on a scale (Mean) |
|---|
| Lidocaine | 6.3 |
| Lidocaine With Dexamethasone | 6.2 |
Patient Satisfaction
Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction (NCT02226159)
Timeframe: 12 weeks
| Intervention | score on a scale (Mean) |
|---|
| Lidocaine | 6.4 |
| Lidocaine With Dexamethasone | 6.6 |
Patient Satisfaction
Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction (NCT02226159)
Timeframe: 12 months
| Intervention | score on a scale (Mean) |
|---|
| Lidocaine | 7.2 |
| Lidocaine With Dexamethasone | 6.8 |
Numeric Pain Score
Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain (NCT02226159)
Timeframe: 6 Months
| Intervention | score on a scale (Mean) |
|---|
| Lidocaine | 3.0 |
| Lidocaine With Dexamethasone | 2.2 |
Numeric Pain Score
Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain (NCT02226159)
Timeframe: 12 weeks
| Intervention | score on a scale (Mean) |
|---|
| Lidocaine | 3.6 |
| Lidocaine With Dexamethasone | 3.4 |
Numeric Pain Score
Verbal Numeric Pain Scale-Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain (NCT02226159)
Timeframe: 12 Months
| Intervention | score on a scale (Mean) |
|---|
| Lidocaine | 2.9 |
| Lidocaine With Dexamethasone | 3.2 |
Disability
Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented). (NCT02226159)
Timeframe: 6 Months
| Intervention | units on a scale (Mean) |
|---|
| Lidocaine | 19.4 |
| Lidocaine With Dexamethasone | 16.3 |
Disability
Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented). (NCT02226159)
Timeframe: 12 weeks
| Intervention | units on a scale (Mean) |
|---|
| Lidocaine | 25.1 |
| Lidocaine With Dexamethasone | 18.3 |
Disability
Neck Disability Index- The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented). (NCT02226159)
Timeframe: 12 Months
| Intervention | units on a scale (Mean) |
|---|
| Lidocaine | 16.4 |
| Lidocaine With Dexamethasone | 15.4 |
Disability
Neck Disability Index (NDI) - The NDI consists of 10 questions. Each of the 10 items is scored from 0 (minimum) - 5(maximum). The maximum score is therefore 50. The obtained score can be multiplied by 2 to produce a percentage score (i.e. a score of 50 indicates 100% disability). Scores are reported as the percentage (i.e. 100 is the max score for data presented). (NCT02226159)
Timeframe: 4 weeks
| Intervention | units on a scale (Mean) |
|---|
| Lidocaine | 25.2 |
| Lidocaine With Dexamethasone | 22.8 |
Numeric Pain Scre
Verbal Numeric Pain Scale (VNPS) -Scaled 0-10 with 10 being worst imaginable pain and 0 being no pain (NCT02226159)
Timeframe: 4 weeks
| Intervention | score on a scale (Mean) |
|---|
| Lidocaine | 3.7 |
| Lidocaine With Dexamethasone | 3.8 |
Avoidance of Neck Surgery
The primary outcome variable is the avoidance of surgery. Treatment success is defined as the avoidance of surgery, while treatment failure is defined as having surgery due to failure of the injection treatment to alleviate pain and improve function over the 12 months they are being followed for purposes of this study. Avoided neck surgery noted as 'Yes'; avoided neck surgery 'No' the patient had neck surgery. (NCT02226159)
Timeframe: 12 months after the first injection
| Intervention | Participants (Count of Participants) |
|---|
| No(had surgery) | Yes (Did not have surgery) |
|---|
| Lidocaine | 24 | 3 |
,| Lidocaine With Dexamethasone | 20 | 6 |
Patient Satisfaction
Patient satisfaction with the treatment. Scale is an inverse of verbal numeric pain score. A 0 on VNPS equates to a 10 on patient satisfaction, 10 on VNPS equates to 0 on patient satisfaction (NCT02226159)
Timeframe: 6 months
| Intervention | score on a scale (Mean) |
|---|
| Lidocaine | 7.0 |
| Lidocaine With Dexamethasone | 7.8 |
Response Rate of IRD Consolidation
For the purposes of this study, response rate is defined as the improvement in complete response rate. Response will be determined by the International Myeloma Working Group (IMWG) Uniform Response Criteria. (NCT02253316)
Timeframe: After 4 cycles of IRD consolidation treatment (approximately Day 112 of consolidation treatment)
| Intervention | Participants (Count of Participants) |
|---|
| Consolidation: Ixazomib, Lenalidomide, & Dexamethasone | 49 |
Rate of MRD-positive to MRD-negative Conversion Between the Two Maintenance Arms
(NCT02253316)
Timeframe: Cycle 13 Day 1 of maintenance treatment (Approximately Day 364 of maintenance treatment)
| Intervention | Participants (Count of Participants) |
|---|
| Maintenance Arm 1: Ixazomib | 5 |
| Maintenance Arm 2: Lenalidomide | 11 |
Number of Participants With Improvement in Minimal Residual Disease (MRD)
For the purposes of this study, a patient will be considered as having minimal residual disease if a positive result (1x10E06) is obtained using the Adaptive Clonoseq MRD testing. (NCT02253316)
Timeframe: After 4 cycles of IRD consolidation treatment (approximately Day 112 of consolidation treatment)
| Intervention | Participants (Count of Participants) |
|---|
| Consolidation: Ixazomib, Lenalidomide, & Dexamethasone | 19 |
MRD-negative Rate After ASCT
For the purposes of this study, a patient will be considered as having minimal residual disease if a positive result (1x10E06) is obtained using the Adaptive Clonoseq MRD testing (NCT02253316)
Timeframe: Prior to beginning consolidation treatment (Day -28 to Day 0)
| Intervention | Participants (Count of Participants) |
|---|
| Consolidation: Ixazomib, Lenalidomide, & Dexamethasone | 51 |
Compare Response Rate Between the Two Maintenance Arms
"Response will be determined by the International Myeloma Working Group (IMWG) Uniform Response Criteria. Response includes stringent complete response (sCR) and complete response (CR).~sCR requires all of the following:~CR as defined below~Normal free light chain ratio (0.26-1.65)~Absence of clonal cells in the bone marrow by immunohistochemistry or immunofluorescence~CR requires all of the following:~Disappearance of monoclonal protein by both protein electrophoresis and immunofixation studies from the blood and urine~If serum and urine monoclonal protein are unmeasurable, Normal free light chain ratio (0.26-1.65)~<5% plasma cells in the bone marrow~Disappearance of soft tissue plasmacytoma" (NCT02253316)
Timeframe: Through completion of maintenance treatment (estimated to be day 1095 of maintenance treatment)
| Intervention | Participants (Count of Participants) |
|---|
| Maintenance Arm 1: Ixazomib | 50 |
| Maintenance Arm 2: Lenalidomide | 80 |
Toxicity of IRD Consolidation
For the purposes of this study, toxicity will be defined as inability to receive 4 cycles of IRD consolidation due to toxicity. (NCT02253316)
Timeframe: After 4 cycles of IRD consolidation treatment (approximately Day 112 of consolidation treatment)
| Intervention | Participants (Count of Participants) |
|---|
| Consolidation: Ixazomib, Lenalidomide, & Dexamethasone | 7 |
Change in Visual Analogue Pain Score
"Pain scores at rest and with activity using a verbal rating scales (VRS) of 0-10, where 0 represents no pain and 10 represents worst pain ever." (NCT02271698)
Timeframe: 6, 12, 18, 24, 36 hours after surgery
| Intervention | units on a scale (Mean) |
|---|
| 6 hour at rest | 6 hour with movement | 12 hour at rest | 12 hour with movement | 18 hour at rest | 18 hour with movement | 24 hour at rest | 24 hour with movement | 36 hour at rest | 36 hour with movement |
|---|
| Dexamethasone 12mg | 4.80 | 6.50 | 3.50 | 6.11 | 2.70 | 5.43 | 3.50 | 6.50 | 3.86 | 7.00 |
,| Dexamethasone 24mg | 3.56 | 5.88 | 2.78 | 6.00 | 2.56 | 4.63 | 3.67 | 6.38 | 4.43 | 6.83 |
,| Dexamethasone 6mg | 3.09 | 4.36 | 2.82 | 5.75 | 1.55 | 4.00 | 2.91 | 4.82 | 3.00 | 5.29 |
,| Placebo | 5.5 | 7.33 | 5.18 | 7.30 | 5.09 | 6.90 | 4.09 | 7.20 | 2.89 | 6.33 |
Change in Opioid Consumption
mg of morphine equivalents (NCT02271698)
Timeframe: 6, 12, 18, 24, 36 hours after surgery
| Intervention | mg of morphine equivalents (Mean) |
|---|
| 6 hours | 12 hours | 18 hours | 24 hours | 36 hours |
|---|
| Dexamethasone 12mg | 22.20 | 27.24 | 16.86 | 20.91 | 24.61 |
,| Dexamethasone 24mg | 11.77 | 54.23 | 43.16 | 25.86 | 36.43 |
,| Dexamethasone 6mg | 21.10 | 42.24 | 20.30 | 25.50 | 27.00 |
,| Placebo | 33.50 | 32.25 | 29.75 | 23.79 | 21.29 |
Change in Functional Status as Measured by Western Ontario and McMaster Universities Osteoarthritis Index
The Western Ontario and McMaster Universities Osteoarthritis Index measures 17 items for functional limitation (score range 0-68). Higher score = higher difficulty with the task. (NCT02271698)
Timeframe: 30 days, 3 and 6 months following surgery
| Intervention | units on a scale (Median) |
|---|
| 30 Days | 3 months | 6 months |
|---|
| Dexamethasone 12mg | 29.5 | 32 | 24.5 |
,| Dexamethasone 24mg | 42 | 19 | 17 |
,| Dexamethasone 6mg | 25 | 17 | 14 |
,| Placebo | 30 | 24 | 16 |
Change in Functional Status as Measured by Brief Pain Inventory Questionnaire
Brief pain inventory questionnaire will be administered generating a score (0-70). Higher scores reflect higher perceived pain interference. (NCT02271698)
Timeframe: Baseline at Enrollment, 3 and 6 months after surgery
| Intervention | units on a scale (Median) |
|---|
| Baseline | 3 Months | 6 Months |
|---|
| Dexamethasone 12mg | 5 | 5 | 1 |
,| Dexamethasone 24mg | 5 | 0 | 0 |
,| Dexamethasone 6mg | 5 | 0 | 0 |
,| Placebo | 4 | 1.5 | 0 |
Change in Chronic Pain as Measured by Brief Pain Inventory Questionnaire
Brief pain inventory questionnaire will be administered generating a score (0-40). Higher scores reflect higher perceived pain. (NCT02271698)
Timeframe: Baseline at enrollment, 3 months and 6 months after surgery
| Intervention | units on a scale (Median) |
|---|
| Baseline | 3 months | 6 months |
|---|
| Dexamethasone 12mg | 5 | 0.5 | 2.5 |
,| Dexamethasone 24mg | 5 | 2 | 1 |
,| Dexamethasone 6mg | 5 | 1 | 0 |
,| Placebo | 4 | 2 | 0 |
Duration of Motor Block
Defined as time from completion of block procedure to return to baseline motor function (in hours) (NCT02322242)
Timeframe: 1 day postoperative
| Intervention | hours (Mean) |
|---|
| Perineural Dexamethasone | 18.5 |
| Systemic Dexamethasone | 20.3 |
Duration of Sensory Block
Defined as time from completion of block procedure to NRS for pain > 0 (in hours) (NCT02322242)
Timeframe: 1 day postoperative
| Intervention | minutes (Mean) |
|---|
| Perineural Dexamethasone | 521 |
| Systemic Dexamethasone | 566 |
Infection
Number of participants with localized infection at nerve block site (NCT02322242)
Timeframe: 7 Days postoperative
| Intervention | Participants (Count of Participants) |
|---|
| Perineural Dexamethasone | 0 |
| Systemic Dexamethasone | 0 |
Number of Participants With Nerve Damage From Interscalene Block
Defined as persistent paresthesia, and sensory/motor block at 7 days (NCT02322242)
Timeframe: 7 Days postoperative
| Intervention | Participants (Count of Participants) |
|---|
| Perineural Dexamethasone | 0 |
| Systemic Dexamethasone | 0 |
Number of Participants With Postoperative Nausea and/or Vomiting
Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively (NCT02322242)
Timeframe: 7 days postoperative
| Intervention | Participants (Count of Participants) |
|---|
| Perineural Dexamethasone | 32 |
| Systemic Dexamethasone | 32 |
Opioid Consumption
Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours, and 7 days (NCT02322242)
Timeframe: 7 days postoperative
| Intervention | mg (oral morphine equivalent) (Mean) |
|---|
| Perineural Dexamethasone | 148.8 |
| Systemic Dexamethasone | 167.2 |
Post-operative Oxygen Saturation on Room Air
Pulse oximetry (in %) measured 1 hour after arrival in post-operative recovery room, scale 0-100, higher number is better (NCT02322242)
Timeframe: 1 hour postoperative
| Intervention | Room air oxygen saturation percent (Mean) |
|---|
| Perineural Dexamethasone | 96.6 |
| Systemic Dexamethasone | 97.0 |
Time to First Opioid Consumption
Defined as time from completion of block procedure to first consumption of opioid analgesic (in hours) (NCT02322242)
Timeframe: 1 day postoperative
| Intervention | hours (Mean) |
|---|
| Perineural Dexamethasone | 9.1 |
| Systemic Dexamethasone | 9.6 |
Numeric Rating Scale for Pain (NRS 0-10)
Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better. (NCT02322242)
Timeframe: 7 days postoperative
| Intervention | units on a scale (Mean) |
|---|
| 7 days | 24hours | 12hours |
|---|
| Perineural Dexamethasone | 3.1 | 4.9 | 3.3 |
,| Systemic Dexamethasone | 3.4 | 4.7 | 3.3 |
Postoperative Serum Blood Glucose
Measured 1 hour after arrival to the post-operative recovery room (NCT02322242)
Timeframe: 1 hour postoperative
| Intervention | mmol/L (Mean) |
|---|
| Perineural Dexamethasone | 6.8 |
| Systemic Dexamethasone | 6.6 |
Event-free Survival (EFS) in Standard Risk Acute Promyelocytic Leukemia (APL) Patients
EFS is defined as the time from on study to failure to achieve hematological complete response (CR) prior to start of consolidation, persistence of molecular positive disease after minimal residual disease (MRD) positive consolidation course, relapse (molecular, morphologic or extramedullary), or death. The Kaplan-Meier method will be used to estimate 2-year EFS along with 90% log-minus-log transformed confidence limits. (NCT02339740)
Timeframe: Up to 24 months
| Intervention | percentage of participants (Number) |
|---|
| Standard Risk | 97.9 |
EFS in High Risk APL Patients
EFS is defined as the time from on study to failure to achieve hematological CR prior to start of consolidation, persistence of molecular positive disease after MRD positive consolidation course, relapse (molecular, morphologic or extramedullary), or death. The Kaplan-Meier method will be used to estimate 2-year EFS along with 90% log-minus-log transformed confidence limits. (NCT02339740)
Timeframe: Up to 24 months
| Intervention | percentage of participants (Number) |
|---|
| High Risk | 96.1 |
Event Free Survival (EFS)
Event free survival defined as the time from treatment to relapse of leukemia or death for any reason or lost to follow-up. Study regimen considered successful if it exhibits a 3-year EFS rate greater than 65% and response rate no less than 90% with Grade III-IV infectious toxicity rate in induction no more than 33%. (NCT02419469)
Timeframe: 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Ofatumumab Plus Chemotherapy | NA |
Progression-free Survival
Time from date of treatment start until the date of first objective documentation of disease-relapse. (NCT02420717)
Timeframe: Up to 4 years 7 months
| Intervention | Months (Median) |
|---|
| Phase I Ruxolitinib 15mg | 2.3 |
| Phase I Ruxolitinib 20mg | 1.8 |
| Phase I Ruxolitinib 25mg | 1.9 |
Maximal Tolerated Dose (MTD) of Ruxolitinib in Combination With Chemotherapy Defined as the Highest Dose Level at Which no More Than 1 Out of 6 Patients Experience a Dose Limiting Toxicity (Phase I)
The method of Thall, Simon and Estey will be used for toxicity monitoring for this study. The severity of the toxicities will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 whenever possible. Safety data will be summarized by category, severity and frequency. (NCT02420717)
Timeframe: 42 days
| Intervention | Milligrams (mg) (Number) |
|---|
| Phase I Ruxolitinib 15mg | 25 |
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT02420717)
Timeframe: Up to 4 years 7 months
| Intervention | Months (Median) |
|---|
| Phase I Ruxolitinib 15mg | 4.8 |
| Phase I Ruxolitinib 20mg | 5.4 |
| Phase I Ruxolitinib 25mg | 38.5 |
Participants With Complete Response (Complete Response [CR]/CR With Incomplete Marrow Recovery [CRi]) (Phase II)
Complete Response (CR) is disappearance of all clinical and/or radiologic evidence of disease, Neutrophil count ≥ 1.0 x 10^9/L, Platelet count ≥ 100 x 10^9/L, Normal bone marrow differential (≤ 5% blasts), No extra-medullary leukemia. Complete Remission with Incomplete Blood Count Recovery (CRi) is CR except for ANC < 1.0 x 10^9/L and/or platelets < 100 x 10^9/L. (NCT02420717)
Timeframe: 42 days
| Intervention | Participants (Count of Participants) |
|---|
| Phase I Ruxolitinib 15mg | 0 |
| Phase I Ruxolitinib 20mg | 1 |
| Phase I Ruxolitinib 25mg | 0 |
VAS
Visual Analogue Pain Scale (VAS) - measurement of pain on scale of 0 (least) to 10 (worst). (NCT02421419)
Timeframe: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, at 6 weeks post-injection and also asked to recollect their pain at time of injection when seen at 6 weeks post-injection
| Intervention | units on a scale (Mean) |
|---|
| VAS pre-injection | VAS 1 minute post-injection | VAS 10 minutes post-injection | VAS 6 weeks post-injection | VAS Recollection |
|---|
| Corticosteroid Alone (CS) Group | 2.2 | 2.3 | 2.1 | 1.5 | 5.2 |
,| Corticosteroid/Lidocaine (CSL) Group | 3.0 | 2.2 | 1.2 | 3.3 | 6.6 |
,| Corticosteroid/Saline (CSS) Group | 3.9 | 4.9 | 3.3 | 4.0 | 5.9 |
Presence of Triggering
Patients are asked how often their finger triggers - not at all, rarely, occasionally, or frequently at time intervals indicated in the outcome measure time frame. Count of participants for each of these answers was collected. (NCT02421419)
Timeframe: Patients are assessed pre-injection (baseline), 1 minute post-injection, 10 minutes post-injection, and 6 weeks post-injection
| Intervention | Participants (Count of Participants) |
|---|
| Triggering frequently pre-injection | Triggering not at all pre-injection | Triggering occasionally pre-injection | Triggering rarely pre-injection | Triggering not at all 1 minute post-injection | Triggering rarely 1 minute post-injection | Triggering occasionally 1 minute post-injection | Triggering frequently 1 minute post-injection | Triggering same as before 1 minute post-injection | Triggering not at all 10 minutes post-injection | Triggering rarely 10 minutes post-injection | Triggering occasionally 10 minutes post-injection | Triggering frequently 10 minutes post-injection | Triggering same as before 10 min. post-injection | Triggering not at all 6 wks post-injection | Triggering rarely 6 wks post-injection | Triggering occasionally 6 weeks post-injection | Triggering frequently 6 wks post-injection | triggering same as before 6 wks post-injection |
|---|
| Corticosteroid Alone (CS) Group | 2 | 0 | 4 | 0 | 3 | 0 | 1 | 0 | 2 | 4 | 0 | 1 | 0 | 1 | 3 | 0 | 0 | 1 | 2 |
,| Corticosteroid/Lidocaine (CSL) Group | 7 | 0 | 4 | 0 | 1 | 0 | 1 | 0 | 8 | 2 | 0 | 1 | 1 | 6 | 1 | 1 | 0 | 1 | 8 |
,| Corticosteroid/Saline (CSS) Group | 5 | 2 | 1 | 0 | 3 | 0 | 0 | 0 | 5 | 4 | 0 | 0 | 0 | 4 | 1 | 0 | 0 | 2 | 5 |
Number of Participants With Adverse Effects
Incidence of adverse effects (NCT02421419)
Timeframe: Patients are assessed 1 minute post-injection, 10 minutes post-injection, and at 6 week post-injection.
| Intervention | Participants (Count of Participants) |
|---|
| Adverse effects 1 minute post-injection | Adverse effects 10 minutes post-injection | Adverse effects 6 weeks post-injection |
|---|
| Corticosteroid Alone (CS) Group | 0 | 0 | 0 |
,| Corticosteroid/Lidocaine (CSL) Group | 0 | 0 | 0 |
,| Corticosteroid/Saline (CSS) Group | 0 | 0 | 0 |
Degree of Triggering
A Green classification number (0-4) is given to each subject pre-injection and at 6 weeks post-injection based on their degree of triggering. 0 = No triggering, no pain; 1 = Pre-triggering; pain, history of catching, but not demonstrable on physical examination; tenderness over the A1 pulley; 2 = Active; demonstrable catching, but the patient can actively extend the digit; 3= Passive; demonstrable catching requiring passive extension or inability to actively flex; and 4 = Contracture; demonstrable catching with a fixed flexion contracture of the PIP joint. (NCT02421419)
Timeframe: Patients are assessed pre-injection objectively by investigator and at 6 weeks post-injection subjectively via Patient Survey
| Intervention | Participants (Count of Participants) |
|---|
| Green classification 0 (pre-injection) | Green classification 1 (pre-injection) | Green classification 2 (pre-injection) | Green classification 3 (pre-injection) | Green Classification 4 (pre-injection) | Green classification 0 (6-weeks post-injection) | Green classification 1 (6-weeks post-injection) | Green classification 2 (6-weeks post-injection) | Green classification 3 (6-weeks post-injection) | Green classification 4 (6-weeks post-injection) |
|---|
| Corticosteroid Alone (CS) Group | 0 | 2 | 4 | 0 | 0 | 2 | 0 | 2 | 2 | 0 |
,| Corticosteroid/Lidocaine (CSL) Group | 0 | 1 | 10 | 0 | 0 | 1 | 0 | 2 | 7 | 1 |
,| Corticosteroid/Saline (CSS) Group | 0 | 1 | 6 | 0 | 1 | 1 | 0 | 4 | 2 | 1 |
Verbal Pain Scores
Verbal Pain Scores will be compared between groups as obtained every six hours during hospitalization. Patients will be asked to provide verbal pain scores both at rest and with movement on a scale of 0-10 (0 being no pain and 10 being the worst pain). These scores will be taken at 0, 6, 12, 18, 24, and 30 hours. (NCT02462148)
Timeframe: 0 to 30 hours
| Intervention | units on a scale (Mean) |
|---|
| 0h | 6h | 12h | 18h | 24h | 30h |
|---|
| 1 mg Perineural Dexamethasone | 2.3 | 1.3 | 2.1 | 1.8 | 1.8 | 3.1 |
,| 4mg Perineural Dexamethasone | 2.1 | 0.8 | 1.7 | 1.6 | 1.5 | 2.4 |
,| Placebo | 2.1 | 1.1 | 3.0 | 3.3 | 3.1 | 4.3 |
Duration of Sensory Nerve Block
The primary outcome will be time to resolution of the nerve block as assessed by pinprick over the saphenous nerve distribution. Testing will occur every two hours. (NCT02462148)
Timeframe: 12 to 48 hours
| Intervention | hours (Mean) |
|---|
| 4 mg Perineural Dexamethasone Group | 37.00 |
| 1 mg Perineural Dexamethasone Group | 31.75 |
| Placebo Group | 29.67 |
Neurologic Complications
Each patient will be followed for neurologic complications (paresthesias, etc) if they should occur. (NCT02462148)
Timeframe: throughout study completion, up to 48 hours
| Intervention | neurological complications (Mean) |
|---|
| 4 mg Perineural Dexamethasone Group | 0 |
| 1 mg Perineural Dexamethasone Group | 0 |
| Placebo Group | 0 |
Post Operative Opioid Use and Consumption
Amount of opioid use and consumption was recorded. (NCT02462148)
Timeframe: 0-30 hours
| Intervention | mg oxycodone equivalents (Mean) |
|---|
| 4 mg Perineural Dexamethasone Group | 27.16 |
| 1 mg Perineural Dexamethasone Group | 26.04 |
| Placebo Group | 42.33 |
Rate of Post Operative Nausea and Vomiting
Number of participants that experienced nausea and vomiting was recorded. (NCT02462148)
Timeframe: 0 to 30 hours
| Intervention | Participants (Count of Participants) |
|---|
| 4 mg Perineural Dexamethasone Group | 5 |
| 1 mg Perineural Dexamethasone Group | 14 |
| Placebo Group | 4 |
Time to First Opioid Analgesic Request
Time it took for the first opioid analgesic request was recorded. (NCT02462148)
Timeframe: 0 to 36 hours
| Intervention | minutes (Mean) |
|---|
| 4 mg Perineural Dexamethasone Group | 686.18 |
| 1 mg Perineural Dexamethasone Group | 654.97 |
| Placebo Group | 658.17 |
Duration of Sensory Blockade
The primary outcome will be duration of sensory blockade in the distribution of the lumbar plexus as determined by pin-prick sensation as tested every two hours with pin-prick sensation. (NCT02464176)
Timeframe: 30 hours
| Intervention | hours (Mean) |
|---|
| 4 mg Dexamethasone Group | 18.5 |
| 8 mg Dexamethasone Group | 18.1 |
| Control Group | 19.6 |
Verbal Numeric Pain Score Comparisons
This secondary outcome includes pain scores utilizing the verbal numeric pain score scale (0 to 11). Higher values indicate worse outcomes (higher pain scores). Lower values are better. (NCT02464176)
Timeframe: 24 hour
| Intervention | scores on a scale (Median) |
|---|
| 4 mg Dexamethasone Group | 3 |
| 8 mg Dexamethasone Group | 2 |
| Control Group | 3 |
Total Opioid Consumption
(NCT02464176)
Timeframe: 30 hours
| Intervention | oxycodone mg equivalents (Median) |
|---|
| 4 mg Dexamethasone Group | 36.6 |
| 8 mg Dexamethasone Group | 30 |
| Control Group | 39.2 |
Time to First Analgesic Request
Time (in minutes) will be recorded to first analgesic request following the block placement (NCT02464176)
Timeframe: 30 hours
| Intervention | minutes (Median) |
|---|
| 4 mg Dexamethasone Group | 474 |
| 8 mg Dexamethasone Group | 533 |
| Control Group | 432 |
Change in Edmonton Symptom Assessment Scale (ESAS) Fatigue
ESAS (Edmonton Symptom Assessment Scale) is a validated scale ranging from 0 (not at all) to 10 (very much) used to assess 10 symptoms commonly experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep and feeling of wellbeing. We measured the change in ESAS fatigue score between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test. Total ESAS fatigue score ranges from 0-10, with a higher score indicating higher fatigue. (NCT02491632)
Timeframe: Baseline, day 8, day 29
| Intervention | score on a scale (Median) |
|---|
| Change between Baseline and Day 8 | Change between Baseline and Day 29 |
|---|
| Physical Exercise + High Dose Dexamethasone | -2 | -3 |
,| Physical Exercise + Low Dose Dexamethasone | -1.5 | -1.5 |
Change in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Levels at Day 8 and Day 29
FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue) subscale is a 13 item subscale of FACT-G that allows patient to rate the intensity of their fatigue and its related symptoms on a scale of 0 (not at all) to 4 (very much). The total calculated score varied from 0-52 with a lower score indicating a more severe fatigue level. We measured the change in FACIT-F levels between Baseline and Day 8, and between Baseline and Day 29 using Wilcoxon signed rank test. (NCT02491632)
Timeframe: Baseline, day 8, day 29
| Intervention | score on a scale (Median) |
|---|
| Change between Baseline and Day 8 | Change between Baseline and Day 29 |
|---|
| Physical Exercise + High Dose Dexamethasone | 8 | 12 |
,| Physical Exercise + Low Dose Dexamethasone | 9 | 10 |
Number of Participants Experiencing a Dose-limiting Toxicity (DLT)
Number of participants experiencing a dose-limiting toxicity (DLT) is reported below. Dose-limiting toxicity is graded by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. (NCT02492750)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Phase I - Dose Level 1 | 0 |
| Phase I - Dose Level 2 | 0 |
| Phase I - Dose Level 3 | 0 |
Nerve Block Duration
Time at which the pain relief from the block has completely worn off (NCT02506660)
Timeframe: Postoperative day 2+
| Intervention | Hours (Median) |
|---|
| Intravenous Dexamethasone | 22.2 |
| Perineural Dexamethasone | 25.7 |
Side Effects
"Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only.~For each symptom, severity is assessed by the question: (If yes), how severe was it usually? (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4)" (NCT02506660)
Timeframe: Postoperative day 2, postoperative day 3
| Intervention | units on a scale (Mean) |
|---|
| Postoperative day 2 | postoperative day 3 |
|---|
| Intravenous Dexamethasone | 0.5 | 0.4 |
,| Perineural Dexamethasone | 0.6 | 0.4 |
Opioid Consumption
(NCT02506660)
Timeframe: Postoperative day 2, postoperative day 3
| Intervention | mg (Mean) |
|---|
| Postoperative day 2 | postoperative day 3 |
|---|
| Intravenous Dexamethasone | 67.3 | 33 |
,| Perineural Dexamethasone | 67.4 | 39.7 |
Numerical Rating Scale Pain Scores
"The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable)" (NCT02506660)
Timeframe: Duration of stay in recovery room after surgery (average of 3 hours)
| Intervention | Units on a Scale (Median) |
|---|
| Intravenous Dexamethasone | 0 |
| Perineural Dexamethasone | 0 |
Block Satisfaction
0-10 scale (0=not satisfied; 10=extremely satisfied) (NCT02506660)
Timeframe: Postoperative day 2, postoperative day 3
| Intervention | units on a scale (Mean) |
|---|
| postoperative day 2 | postoperative day 3 |
|---|
| Intravenous Dexamethasone | 8.1 | 8.0 |
,| Perineural Dexamethasone | 8.1 | 7.5 |
% of Participants Who Guessed the Correct Group
Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group (NCT02506660)
Timeframe: Postoperative day 7-10
| Intervention | % of participants (Number) |
|---|
| Intravenous Dexamethasone | -7 |
| Perineural Dexamethasone | 3.4 |
Progression-free Survival
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. (NCT02547662)
Timeframe: 4 years 8 months
| Intervention | Months (Median) |
|---|
| Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 4.5 |
Incidence of Adverse Events Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Number of patients with adverse events is reported here, the full list of those adverse events and their frequency is reported in the adverse event section. (NCT02547662)
Timeframe: 4 years 1 month
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 17 |
Extramedullary Response Rate
Extramedullary response, defined as a response by extramedullary plasmacytoma or plasma cell count parameters. The extramedullary response rate will be estimated by the number of responders(patients that achieved a partial or complete response) divided by the number of evaluable patients. Exact binomial confidence intervals will be calculated. (NCT02547662)
Timeframe: 4 years
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 0.40 |
Confirmed Response Rate
A confirmed response is defined as a patient who has achieved a stringent complete response (sCR), complete response (CR), very good partial response (PR), or PR on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Ninety-five percent confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. (NCT02547662)
Timeframe: 4 years
| Intervention | proportion of patients (Number) |
|---|
| Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 0.06 |
Biochemical Response Rate
The biochemical response rate will be estimated by the number of responders(patients that achieved partial or complete response) divided by the number of evaluable patients who have measurable disease by serum M-protein, urine M-protein, or serum FLC assay at baseline. Exact binomial confidence intervals will be calculated. (NCT02547662)
Timeframe: 4 years
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Ixazomib Citrate, Pomalidomide, Dexamethasone) | 0.25 |
Percent of Participants With Central Nervous System (CNS) Progression Free Survival (PFS)
The study team will assess the percent of participants without CNS progression at 3 months. The study team will generate a Kaplan- Meier curve of CNS PFS and estimate the PFS and 95% confidence interval (CI) of the PFS. Response and progression by MR were evaluated using WHO/modified McDonald's criteria. (NCT02581839)
Timeframe: At 12 weeks
| Intervention | percentage of participants (Number) |
|---|
| Eribulin Mesylate | 88.9 |
Objective Response Rate (RR)
The study team will calculate the percent of participants with complete and partial response. Response and progression by MR were evaluated using WHO/modified McDonald's criteria. (NCT02581839)
Timeframe: up to 2 years from start of treatment
| Intervention | percentage of participants (Number) |
|---|
| Eribulin Mesylate | 11.1 |
Number of Patients With CBR
The study team will sum the proportion of the patients with complete response, partial response and stable disease at 12 weeks (CBR) (NCT02581839)
Timeframe: At 12 weeks
| Intervention | Participants (Count of Participants) |
|---|
| Eribulin Mesylate | 5 |
Number of Patients Treated With Eribulin Who Experienced Serious Adverse Events
The study team will evaluate rates (and 95% CI) of toxicity in patients treated with eribulin. (NCT02581839)
Timeframe: up to 2 years from start of treatment
| Intervention | Participants (Count of Participants) |
|---|
| Eribulin Mesylate | 3 |
Overall Survival (Phase II)
The distribution of overall survival will be estimated using the method of Kaplan-Meier. (NCT02633059)
Timeframe: Up to 3 years
| Intervention | months (Median) |
|---|
| Phase II and MTD | 21.0 |
Rate of Confirmed Response, Defined as a Patient Who Has Achieved a Stringent Complete Response (sCR), Complete Response (CR), Very Good Partial Response (VGPR), or Partial Response (PR) on Two Consecutive Evaluations (Phase II)
Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in this patient population. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated. (NCT02633059)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| PR | SD | NA | CR | VGPR | sCR |
|---|
| Phase II and MTD | 2 | 6 | 14 | 0 | 0 | 0 |
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase II)
The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. (NCT02633059)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Grade 3+ Adverse Events, Regardless of Attribution | Grade 3+ Adverse Events, At Least Possibly Related | Grade 4+ Adverse Events, Regardless of Attribution | Grade 4+ Adverse Events, At Least Possibly Related | Grade 5 Adverse Events, Regardless of Attribution | Grade 5 Adverse Events, At Least Possibly Related | Grade 3+ Heme Adverse Events, Regardless of Attribution | Grade 3+ Heme Adverse Events, At Least Possibly Related | Grade 4+ Heme Adverse Events, Regardless of Attribution | Grade 4+ Heme Adverse Events, At Least Possibly Related | Grade 5 Heme Adverse Events, Regardless of Attribution | Grade 5 Heme Adverse Events, At Least Possibly Related | Grade 3+ Non-heme Adverse Events, Regardless of Attribution | Grade 3+ Non-heme Adverse Events, At Least Possibly Related | Grade 4+ Non-heme Adverse Events, Regardless of Attribution | Grade 4+ Non-heme Adverse Events, At Least Possibly Related | Grade 5 Non-heme Adverse Events, Regardless of Attribution | Grade 5 Non-heme Adverse Events, At Least Possibly Related |
|---|
| Phase 2: Dose Level 1 | 14 | 13 | 10 | 9 | 2 | 0 | 13 | 13 | 9 | 9 | 0 | 0 | 5 | 3 | 4 | 2 | 2 | 0 |
Incidence of Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 (Phase I)
Overall toxicity incidence as well as toxicity profiles by dose level, patient and tumor site will be explored and summarized. Frequency distributions, graphical techniques and other descriptive measures will form the basis of these analyses. (NCT02633059)
Timeframe: 30 days after the last dose of study treatment, up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Grade 3+ Adverse Events, Regardless of Attribution | Grade 3+ Adverse Events, At Least Possibly Related | Grade 4+ Adverse Events, Regardless of Attribution | Grade 4+ Adverse Events, At Least Possibly Related | Grade 5 Adverse Events, Regardless of Attribution | Grade 5 Adverse Events, At Least Possibly Related | Grade 3+ Heme Adverse Events, Regardless of Attribution | Grade 3+ Heme Adverse Events, At Least Possibly Related | Grade 4+ Heme Adverse Events, Regardless of Attribution | Grade 4+ Heme Adverse Events, At Least Possibly Related | Grade 5 Heme Adverse Events, Regardless of Attribution | Grade 5 Heme Adverse Events, At Least Possibly Related | Grade 3+ Non-heme Adverse Events, Regardless of Attribution | Grade 3+ Non-heme Adverse Events, At Least Possibly Related | Grade 4+ Non-heme Adverse Events, Regardless of Attribution | Grade 4+ Non-heme Adverse Events, At Least Possibly Related | Grade 5 Non-heme Adverse Events, Regardless of Attribution | Grade 5 Non-heme Adverse Events, At Least Possibly Related |
|---|
| Phase 1: Dose Level 0 | 3 | 2 | 0 | 0 | 0 | 0 | 3 | 2 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
,| Phase 1: Dose Level 1 | 4 | 4 | 1 | 1 | 0 | 0 | 4 | 4 | 1 | 1 | 0 | 0 | 2 | 1 | 0 | 0 | 0 | 0 |
,| Phase 1: Dose Level 2 | 3 | 3 | 3 | 2 | 0 | 0 | 3 | 3 | 3 | 2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The Number of Participants Who Experienced Dose Limiting Toxicities. Maximum Tolerated Dose (MTD) of Ixazomib Citrate and Idasanutlin in Combination With Dexamethasone (Phase I)
Defined as the dose level below the lowest dose that induces dose-limiting toxicity (DLT) in at least one-third of patients (at least 2 of a maximum of 6 new patients). DLT is graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. (NCT02633059)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Phase 1: Dose Level 0 | 0 |
| Phase 1: Dose Level 1 | 0 |
| Phase 1: Dose Level 2 | 2 |
| Phase 2: Dose Level 1 | 1 |
Rate of Partial Response (PR) (Phase II)
The rate of PR will be estimated by the number of patients with a VGPR or PR divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportions will be calculated. (NCT02633059)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Phase II and MTD | 2 |
Rate of Complete Response (CR) (Phase II)
The rate of CR will be estimated by the number of patients with a sCR or CR or divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportions will be calculated. (NCT02633059)
Timeframe: Up to 6 months
| Intervention | Participants (Count of Participants) |
|---|
| Phase II and MTD | 0 |
Progression Free Survival (Phase II)
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. (NCT02633059)
Timeframe: Up to 3 years
| Intervention | months (Median) |
|---|
| Phase II and MTD | 3.8 |
Overall Survival (OS)
OS is the time from randomization to the date of death from any cause. The survival time for participants who had not died was censored at the last known alive date. OS was censored at the date of randomization for subjects who were randomized but had no follow-up. (NCT02654132)
Timeframe: From randomization to death (up to approximately 52 months)
| Intervention | Months (Median) |
|---|
| E-Pd Cohort | 29.80 |
| Pd Cohort | 17.41 |
Objective Response Rate (ORR)
"ORR is defined as the percentage of participants who achieved a best overall response (BOR) of stringent complete response (sCR), complete response (CR), very good partial response (VGPR) or partial response (PR) using the modified International Myeloma Working Group (IMWG) criteria described as follows, as per investigator's assessment~CR: Negative immunofixation of serum and urine and disappearance of any soft tissue plasmacytomas, and < 5% plasma cells in bone marrow~sCR: CR, as defined above, plus the following: Normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence~VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or >= 90% reduction in serum M-protein level plus urine M-protein level < 100 mg per 24 hour~PR: >= 50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >= 90% or to < 200 mg per 24 hour." (NCT02654132)
Timeframe: From first dose to disease progression (up to approximately 21 months)
| Intervention | Percent of participants (Number) |
|---|
| E-Pd Cohort | 58.3 |
| Pd Cohort | 24.6 |
Progression Free Survival (PFS)
"PFS is defined as the time from randomization to the date of the first documented tumor progression or death due to any cause. Progressive disease response criteria were defined as an increase of 25% from lowest response value in any one or more of the following:~1. Serum M-component and/or 2. Urine M-component and/or 3. Only in patients without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels 4. Bone marrow plasma cell percentage; Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia that can be attributed solely to the plasma cell proliferative disorder" (NCT02654132)
Timeframe: From randomization to date of progression or death (up to approximately 21 months)
| Intervention | Months (Median) |
|---|
| E-Pd Cohort | 10.25 |
| Pd Cohort | 4.70 |
Occurrence of Postoperative Neuropraxia
Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit. (NCT02688530)
Timeframe: Post-Operative Day 21
| Intervention | Participants (Count of Participants) |
|---|
| 0mg IV Dexamethasone | 0 |
| 4mg IV Dexamethasone | 1 |
| 6mg IV Dexamethasone | 0 |
| 8mg IV Dexamethasone | 0 |
Duration of Motor Block From the Supraclavicular Block
Defined as the time from block placement to restoration of normal strength at both the wrist and elbow. (NCT02688530)
Timeframe: Day of Surgery until Post-Operative Day 3 (if the block persists)
| Intervention | Hours (Median) |
|---|
| 0mg IV Dexamethasone | 10.5 |
| 4mg IV Dexamethasone | 19.7 |
| 6mg IV Dexamethasone | 18.3 |
| 8mg IV Dexamethasone | 14.7 |
Cumulative Daily Opioid Usage
Dosages (reported in Morphine equivalent units) of opioid medication obtained by medical records and/or by patient interview. (NCT02688530)
Timeframe: Recovery Room until Post-Operative Day 3 (if block persists)
| Intervention | oral morphine equivalent units (mg) (Mean) |
|---|
| POD 1 (0-24hrs) | POD2 (24-48hrs) |
|---|
| 0mg IV Dexamethasone | 31 | 22.3 |
,| 4mg IV Dexamethasone | 30.5 | 27.4 |
,| 6mg IV Dexamethasone | 30.7 | 32.6 |
,| 8mg IV Dexamethasone | 31.3 | 36.5 |
Blood Glucose Levels
Fingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration. (NCT02688530)
Timeframe: Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration
| Intervention | mg/dL (Median) |
|---|
| Prior to IV Dexamethasone | 1 hour after IV Dexamethasone | 2 hours after IV Dexamethasone |
|---|
| 0mg IV Dexamethasone | 102 | 119 | 102 |
,| 4mg IV Dexamethasone | 108 | 122 | 125 |
,| 6mg IV Dexamethasone | 104 | 119 | 110 |
,| 8mg IV Dexamethasone | 105 | 126 | 110 |
Average Daily Pain Scores at Rest and With Movement
Using the Numeric Rating Scale (NRS) Pain obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible). (NCT02688530)
Timeframe: Day of Surgery until Post-Operative Day 3 (if the block persists)
| Intervention | score on a scale (Mean) |
|---|
| Pre-Op Average Pain Score at rest | POD0 Average Pain Score at rest | POD1 Average Pain Score at rest | POD2 Average Pain Score at rest | POD3 Average Pain Score at rest | Pre-Op Average Pain Score with Movement | POD0 Average Pain Score with Movement | POD1 Average Pain Score with Movement | POD2 Average Pain Score with Movement | POD3 Average Pain Score with Movement |
|---|
| 0mg IV Dexamethasone | 2.6 | 0.4 | 4.1 | 2.9 | 0.5 | 4.6 | 0.5 | 5.2 | 4.6 | 6 |
,| 4mg IV Dexamethasone | 3 | 0.2 | 3.2 | 3.7 | 4 | 4.8 | 0.3 | 4.7 | 5.1 | 5 |
,| 6mg IV Dexamethasone | 2.4 | 0.4 | 3.1 | 3.3 | 3 | 4.6 | 0.2 | 4.8 | 5 | 6 |
,| 8mg IV Dexamethasone | 2.5 | 0.5 | 3 | 3.1 | 2 | 4.7 | 0.4 | 4.2 | 4.8 | 1.7 |
Patient Satisfaction With Postoperative Analgesia
Patient satisfaction with postoperative analgesia will be obtained by patient interview. Lower numbers represent worse outcomes. The scale range is from 0 (worst) to 10 (best). (NCT02688530)
Timeframe: Post-Operative Day 2 or Post-Operative Day 3 (if the block persists)
| Intervention | score on a scale (Mean) |
|---|
| 0mg IV Dexamethasone | 9.1 |
| 4mg IV Dexamethasone | 8.9 |
| 6mg IV Dexamethasone | 9.2 |
| 8mg IV Dexamethasone | 8.7 |
Occurrence of Postoperative Wound Infection
Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit. (NCT02688530)
Timeframe: Post-Operative Day 21
| Intervention | Participants (Count of Participants) |
|---|
| 0mg IV Dexamethasone | 0 |
| 4mg IV Dexamethasone | 0 |
| 6mg IV Dexamethasone | 0 |
| 8mg IV Dexamethasone | 0 |
Worst Daily Pain Scores at Rest and With Movement
Using the numeric pain rating scale (NRS), will be obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible). (NCT02688530)
Timeframe: Day of Surgery until Post-Operative Day 3 (if the block persists)
| Intervention | score on a scale (Mean) |
|---|
| Pre-Op Worst Pain Score at rest | POD0 Worst Pain Score at rest | POD1 Worst Pain Score at rest | POD2 Worst Pain Score at rest | POD3 Worst Pain Score at rest | Pre-Op Worst Pain Score with Movement | POD0 Worst Pain Score with Movement | POD1 Worst Pain Score with Movement | POD2 Worst Pain Score with Movement | POD3 Worst Pain Score with Movement |
|---|
| 0mg IV Dexamethasone | 3.4 | 0.6 | 6.3 | 4.7 | 2 | 6.1 | 0.6 | 7.3 | 6.5 | 7 |
,| 4mg IV Dexamethasone | 3.3 | 0.2 | 4.6 | 5.4 | 6.3 | 6.5 | 0.3 | 5.9 | 6.8 | 6.7 |
,| 6mg IV Dexamethasone | 3.4 | 0.5 | 5.4 | 5.1 | 5 | 6.4 | 0.3 | 6.5 | 6.7 | 7 |
,| 8mg IV Dexamethasone | 3.6 | 1.1 | 5.1 | 4.5 | 4.3 | 6.9 | 1.2 | 5.7 | 6.3 | 3.7 |
Number of Participants With Complete Response (CR) of Rolapitant Hydrochloride Administered as a Single-dose
Complete response (CR) no emetic episodes and no rescue medications. (NCT02732015)
Timeframe: Days 1-10
| Intervention | Participants (Count of Participants) |
|---|
| Cohort 1 | 0 |
| Cohort 2 | 5 |
Cumulative 24 Hour Oral Morphine Equivalent Consumption
Post-operative analgesia at 24 hours (NCT02798835)
Timeframe: 24 hours (Day 1)
| Intervention | mg (Median) |
|---|
| Adductor Canal Block | 111.8 |
| Adductor Canal Block With Dexamethasone | 118 |
| Adductor Canal Catheter | 153 |
Quality of Recovery (QoR-40)
Quality of recovery measured using the QoR-40 at 48 hours postoperatively. This is a validated scale where a higher score denotes better recovery/satisfaction after surgery. The range is 40-200. (NCT02798835)
Timeframe: 48 hours (Day 2)
| Intervention | score on a scale (Mean) |
|---|
| Adductor Canal Block | 160.5 |
| Adductor Canal Block With Dexamethasone | 166.5 |
| Adductor Canal Catheter | 167.2 |
Incidence of Participants With Nausea/Vomiting Requiring Anti-emetics
Number of Participants with Nausea/Vomiting requiring anti-emetics from 0-48 hours after surgery. (NCT02798835)
Timeframe: 0 to 48 hours
| Intervention | Participants (Count of Participants) |
|---|
| 0-12h | 12-24h | 24-48h |
|---|
| Adductor Canal Block | 19 | 26 | 15 |
,| Adductor Canal Block With Dexamethasone | 14 | 17 | 17 |
,| Adductor Canal Catheter | 19 | 24 | 17 |
Time to First Use of PCA
from time zero to first press of PCA button (NCT02798835)
Timeframe: 0 to 48 hours
| Intervention | hours (Median) |
|---|
| Adductor Canal Block | 4.1 |
| Adductor Canal Block With Dexamethasone | 4.9 |
| Adductor Canal Catheter | 3.8 |
Nerve Block Complications
Nerve block complications at any time point during study (NCT02798835)
Timeframe: 0 to 48 hours
| Intervention | Participants (Count of Participants) |
|---|
| Adductor Canal Block | 0 |
| Adductor Canal Block With Dexamethasone | 0 |
| Adductor Canal Catheter | 0 |
Length of Stay
Time to hospital discharge (NCT02798835)
Timeframe: From surgical date until hospital discharge, up to 3 weeks
| Intervention | hours (Median) |
|---|
| Adductor Canal Block | 70.8 |
| Adductor Canal Block With Dexamethasone | 71.5 |
| Adductor Canal Catheter | 71.5 |
Cumulative 48 Hour Oral Morphine Equivalent Consumption
Post-operative analgesia at 48 hours (NCT02798835)
Timeframe: 48 hours (Day 2)
| Intervention | mg (Median) |
|---|
| Adductor Canal Block | 192.9 |
| Adductor Canal Block With Dexamethasone | 196 |
| Adductor Canal Catheter | 223.5 |
Adductor Canal Block Complications
Incidence of catheter dislodgement or site infection (NCT02798835)
Timeframe: From time of catheter insertion until catheter removal, up to Day2/48 hours
| Intervention | Participants (Count of Participants) |
|---|
| Adductor Canal Block | 0 |
| Adductor Canal Block With Dexamethasone | 0 |
| Adductor Canal Catheter | 0 |
Cumulative 12 Hour Oral Morphine Equivalent Consumption
Post-operative analgesia at 12 hours (NCT02798835)
Timeframe: 12 hours (Day 0)
| Intervention | mg (Median) |
|---|
| Adductor Canal Block | 61.5 |
| Adductor Canal Block With Dexamethasone | 49.5 |
| Adductor Canal Catheter | 82 |
Pain Score
Patient's level of pain using NRS (Numeric Ratings Scale) pain scale where the range is 0 (no pain) to 10 (worst pain) (NCT02798835)
Timeframe: 12, 24 and 48 hours
| Intervention | score on a scale (Median) |
|---|
| 12h | 24h | 48h |
|---|
| Adductor Canal Block | 3 | 3 | 2 |
,| Adductor Canal Block With Dexamethasone | 3 | 3 | 3 |
,| Adductor Canal Catheter | 4 | 3 | 3 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to First Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients before the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 1 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 78.17 |
Tolerability of Azacitidine in Combination With Interfant-06 Standard Chemotherapy in Evaluable Infant Patients With Newly Diagnosed ALL With KMT2A Gene Rearrangement (KMT2A-R). KMT2A Gene Rearrangement (KMT2A-R)
Proportion of KMT2A-Rearranged patients treated with azacitidine with Dose Limiting Toxicities (DLTs) from the first course of azacitidine administration up to fourth course of azacitidine administration. (NCT02828358)
Timeframe: 6 months
| Intervention | percentage of participants (Number) |
|---|
| KMT2A-Rearranged | 6.45 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of Second Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients after the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 5 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 74.52 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 5 of First Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients after the first course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 6, Day 5 (Following the induction phase (35 days), the first course of Azacitidine began around Week 6 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 75.54 |
Biologic Activity, Defined as Global Deoxyribonucleic Acid (DNA) Methylation Change in Peripheral Blood Mononuclear Cells (PBMC)s; Day 1 Prior to Second Course of Azacitidine
Will calculate the percentage of CpG site methylation for all patients before the second course of azacitidine. Mean and standard deviation will be reported. (NCT02828358)
Timeframe: Week 13, Day 1 (Following induction phase (5 weeks), the first course of Azacitidine (1 week), and consolidation (6 weeks), the second course of Azacitidine began around Week 13 of therapy)
| Intervention | Percentage of CpG methylation (Mean) |
|---|
| KMT2A-Rearranged | 76.5 |
Proportion of Complete Response Plus Very Good Partial Response (VGPR)
"The International Myeloma Working Group response criteria was used to assess response to therapy. The proportion of VGPR response at any time during treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients achieving a VGPR, CR, or sCR at any time divided by the total number of evaluable patients. A very good partial response (VGPR) is defined as as a demonstration of:~Serum and urine M-component detectable by immunofixation but not on electrophoresis c or~greater than 90% reduction in serum m-component and urine m-component <100 mg/24 h~If the only measurable disease is FLC, a ≥90% reduction in the difference between involved and involved FLC levels~The proportion of successes will be estimated by the number of patients demonstrating a VGPR or better divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner." (NCT02880228)
Timeframe: Up to 112 days
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Lenalidomide, Dexamethasone, Pembrolizumab) | 0 |
Survival Time
Survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT02880228)
Timeframe: From time of registration to death due to any cause, assessed up to 3 years
| Intervention | months (Median) |
|---|
| Treatment (Lenalidomide, Dexamethasone, Pembrolizumab) | NA |
Partial Response (PR)
"The PR response after 4 cycles of induction treatment with pembrolizumab added to lenalidomide and dexamethasone will be estimated by the number of patients who achieve a PR, VGPR, CR, or sCR after 4 cycles divided by the total number of evaluable patients. A PR is defined by the following criteria:>~If present at baseline, ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein or to <200 mg/24hrs>~If the only measurable disease is FLC, a ≥50% reduction in the difference between involved and involved FLC levels>~If the only measurable disease is BM, a ≥50% reduction in BM PC's (provided the baseline PC's was ≥30%)>~If present at baseline, ≥50% reduction in the size of soft tissue plasmacytomas>~Exact binomial 95% confidence intervals for the true success rate will be calculated." (NCT02880228)
Timeframe: Up to 112 days
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Lenalidomide, Dexamethasone, Pembrolizumab) | 0 |
Proportion of Successful Stem Cell Collection
The proportion of successful stem cell collection following initial therapy with the combination of pembrolizumab, lenalidomide and dexamethasone in patients with newly diagnosed MM will be estimated by the number of patients with a successful stem cell collection divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true successful proportion will be calculated. (NCT02880228)
Timeframe: Up to 112 days
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Lenalidomide, Dexamethasone, Pembrolizumab) | 0.4 |
Progression-free Survival
Progression-free survival is defined as the time from registration to the earliest date of documentation of disease progression or death due to any cause. Patients who receive subsequent treatment for myeloma before disease progression will be censored on the date of their last disease assessment prior to initiation of the subsequent treatment. Transplant will not be considered subsequent treatment. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. (NCT02880228)
Timeframe: From registration to the earliest date of documentation of disease progression or death due to any cause, assessed up to 3 years
| Intervention | months (Median) |
|---|
| Treatment (Lenalidomide, Dexamethasone, Pembrolizumab) | NA |
SF-MPQ2 Intermittent Pain Subscore Difference From Baseline
Intermittent pain subscore difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain. (NCT02891798)
Timeframe: Baseline, Post-Operative day after surgery (7AM-9AM EST)
| Intervention | units on a scale (Mean) |
|---|
| Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | -2.79 |
| Bupivacaine Only (Control Arm) | -1.14 |
SF-MPQ2 Continuous Pain Subscore Difference From Baseline
Continuous pain subscore difference of Post-Operative Day 1 value minus the Baseline value. Differences can range from -10 to +10. Negative scores indicate a decrease in pain. (NCT02891798)
Timeframe: Baseline, Post-Operative day after surgery (7AM-9AM EST)
| Intervention | units on a scale (Mean) |
|---|
| Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | -2.29 |
| Bupivacaine Only (Control Arm) | 0.33 |
Quality of Recovery 15 Item Scale (QoR-15) Total Score
Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery. (NCT02891798)
Timeframe: Day after surgery (7AM-9AM EST)
| Intervention | score on a scale (Mean) |
|---|
| Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | 106.08 |
| Bupivacaine Only (Control Arm) | 90.13 |
Quality of Recovery 15 Item Scale (QoR-15) Total Score
Quality of Recovery 15 Item Scale, total score 0-150, 150 reflecting a perfect score and better recovery. (NCT02891798)
Timeframe: 6 weeks post-operation
| Intervention | score on a scale (Mean) |
|---|
| Bupivacaine + BCD (Buprenorphine, Clonidine, Dexamethasone) | 128.89 |
| Bupivacaine Only (Control Arm) | 130.06 |
Visual Analogic Scale (0-100) for Tooth Sensibility.
The investigators evaluated the tooth sensibility 1 hour post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility (NCT02956070)
Timeframe: One hour
| Intervention | units on a scale (Mean) |
|---|
| Experimental | 6.31 |
| Placebo | 11.14 |
Visual Analogic Scale(0-100) for Tooth Sensibility.
The investigators evaluated the tooth sensibility 24 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility (NCT02956070)
Timeframe: Twenty four hours
| Intervention | units on a scale (Mean) |
|---|
| Experimental | 5.06 |
| Placebo | 8.26 |
Visual Analogic Scale(0-100) for Tooth Sensibility.
The investigators evaluated the tooth sensibility 48 hours post-bleaching. Scale from 0-100 0 means no sensibility 100 means maximum sensibility (NCT02956070)
Timeframe: Forty eight hours
| Intervention | units on a scale (Mean) |
|---|
| Experimental | 0.37 |
| Placebo | 2.91 |
Incidence of Transient Neurologic Symptoms
(NCT02996591)
Timeframe: Postoperative day 1 and if present, monitored until resolution
| Intervention | Participants (Count of Participants) |
|---|
| Normal | Transient Neurological Symptoms |
|---|
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 18 | 0 |
,| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 18 | 0 |
Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)
Rating the Nausea/Vomiting of patients post-operatively. (NCT02996591)
Timeframe: 2 hours after surgery
| Intervention | score on a scale (Mean) |
|---|
| Pain | Sore Throat | Back Pain | Vomiting | Cold | Hunger | Thirst |
|---|
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 1.4 | 1.6 | 1.2 | 1 | 1.1 | 1.2 | 1.8 |
,| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 1.2 | 1.2 | 1.1 | 1 | 1.1 | 1.4 | 2.1 |
Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)
Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq). From 1-5. 1 being not at all. 5 being extremely. (NCT02996591)
Timeframe: Postoperative day 1
| Intervention | score on a scale (Mean) |
|---|
| Pain | Sore Throat | Back Pain | Vomiting | Cold | Hunger | Thirst |
|---|
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 1.5 | 1.5 | 1.2 | 1 | 1 | 1.7 | 2.2 |
,| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 1.4 | 1.2 | 1.1 | 1 | 1.3 | 1.4 | 2.3 |
Postoperative Discomfort and Needs (Post-op Pain, Sore Throat, Back Pain, Nausea, Cold, Hunger, Thirst)
Leiden Perioperative Care Patient Satisfaction questionnaire (LPPSq) score. Performed at 1 hour postoperatively. To what degree did patients have the following symptoms. Rated 1-5, 1 being not at all. 5 being extremely. (NCT02996591)
Timeframe: 1 hour after surgery
| Intervention | score on a scale (Mean) |
|---|
| Pain | A Sore Throat | Back Pain | Vomiting | Cold | Hunger | Thirst |
|---|
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 1.6 | 1.6 | 1.2 | 1 | 1.3 | 1.7 | 2.5 |
,| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 1.1 | 1.2 | 1.2 | 1 | 1.4 | 1.9 | 2.7 |
Numerical Rating Scale Pain Scores on Postoperative Day (POD) 1
Numerical Rating Scale Pain from 0-10. 0 being no pain at all. 10 being the worst pain imaginable. (NCT02996591)
Timeframe: 24 hours after surgery
| Intervention | score on a scale (Mean) |
|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 1 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 1 |
Cognitive Recovery on POD1
Postoperative Quality Recovery Scale Cognitive Domain questionnaire. Asked on postoperative day 1. Either yes (return to pre-operative cognitive function levels) or no (not yet returned to pre-operative function levels) (NCT02996591)
Timeframe: Postoperative day 1
| Intervention | Participants (Count of Participants) |
|---|
| No | Yes |
|---|
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 2 | 15 |
,| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 3 | 14 |
Numerical Rating Scale (NRS) Pain Scores at 1 Hour Postop
NRS Pain scores at 1 hour after surgery. Rated on a scale of 0 (no pain) to 10 (worst pain imaginable). (NCT02996591)
Timeframe: 1 hour after PACU admission
| Intervention | units on a scale (Mean) |
|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 0 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 1.8 |
Back Pain on POD1
Back pain (yes/no) on POD1 (NCT02996591)
Timeframe: Postoperative day 1
| Intervention | Participants (Count of Participants) |
|---|
| No | Yes |
|---|
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 14 | 3 |
,| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 16 | 2 |
Time Until Patient is Ready for Discharge From Post-Anesthesia Care Unit (PACU) to Home.
Modified Aldrete Scoring System and Marshall and Chung Postanesthesia Discharge Scoring System, measured in time until discharge criteria is met (in minutes) (NCT02996591)
Timeframe: Duration of stay in recovery room after surgery
| Intervention | Minutes (Mean) |
|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 81 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 43.5 |
Cognitive Recovery at 2 Hours Post-operative
Postoperative Quality Recovery Scale Cognitive Domain questionnaire. Asked at 2 hour post-operatively. Either yes (return to pre-operative cognitive function levels) or no (not yet returned to pre-operative function levels) (NCT02996591)
Timeframe: 2 hours after PACU admission
| Intervention | Participants (Count of Participants) |
|---|
| No | Yes |
|---|
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 4 | 13 |
,| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 1 | 16 |
Opioid Consumption Through First Postoperative Day. Measured in mg OME
(NCT02996591)
Timeframe: Postoperative day 1
| Intervention | mg OME (Mean) |
|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 8.3 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 11 |
Assessment of Patient Blinding to Group Assignment
Patients will be asked whether they believe they were in the general anesthesia or spinal anesthesia group. These responses are then validated using the Bang Blinding Index, which either confirms or refutes the validity of the blinding. The scale runs from -1 to 1, with a score of 0 indicating complete blinding, -1 indicating opposite guessing of groups, and 1 indicating a complete lack of blinding. (NCT02996591)
Timeframe: Postoperative day 1
| Intervention | Bang blinding index (Number) |
|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | .588 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | .722 |
Nausea Intensity
Nausea intensity ranked on NRS score following PACU admission to 2 hours after discharge. Scored from 0-10. 0 Being no nausea, 10 being worst nausea imaginable. (NCT02996591)
Timeframe: 2 hours after PACU admission
| Intervention | score on a scale (Mean) |
|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 0 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 0 |
Opioid Consumption
Opioid consumption (mg OME) during inpatient stay (NCT02996591)
Timeframe: Duration of stay in recovery room after surgery (average 2 hours)
| Intervention | mg OME (Mean) |
|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | 2.2 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | 5 |
Numerical Rating Scale Pain Scores at 2 Hours Postop
Numerical rating scale pain score as reported by the patient at 2 hours post-operatively. Rated on a scale of 0 (no pain) to 10 (worst pain imaginable). (NCT02996591)
Timeframe: 2 hours after PACU admission
| Intervention | units on a scale (Mean) |
|---|
| Spinal Anesthesia With Popliteal and Adductor Canal Blocks. | .4 |
| General Anesthesia With Popliteal and Adductor Canal Blocks. | .9 |
Percentage of Participants With Objective Response
Objective response was defined as percentage of participants with complete response (CR) or with complete response with incomplete peripheral recovery (CRi) as per National Comprehensive Cancer Network (NCCN) guidelines. CR was defined as no circulating blasts or extramedullary disease, no lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/central nervous system involvement, trilineage hematopoiesis and less than 5 percentage blasts, absolute neutrophil count (ANC) greater than 1000 per micro liter, platelets less than 100 000 per micro liter, no recurrence for 4 weeks. CRi meet all criteria for complete response except platelet count and/or ANC. (NCT02999633)
Timeframe: Baseline until disease progression or death (maximum duration: 12.1 weeks)
| Intervention | percentage of participants (Number) |
|---|
| Isatuximab | 0 |
Overall Survival (OS) in Participants With Extensive-Stage Small Cell Lung Cancer With Delta-Like Protein 3 High Expression in Tumor (DLL3high)
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology. (NCT03033511)
Timeframe: Survival follow-up continued until the endpoint of death, participant was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
| Intervention | months (Median) |
|---|
| Placebo | 9.79 |
| Rovalpituzumab Tesirine/Dexamethasone | 8.48 |
OS in All Randomized Participants
OS is defined as the number of months from randomization to death of any cause. Calculated using the Kaplan-Meier methodology. (NCT03033511)
Timeframe: Survival follow-up continued until the endpoint of death, the subject was lost to follow-up or withdrew consent, or termination of the study by AbbVie, whichever occurred first. Median time on study overall was 11.9 months.
| Intervention | months (Median) |
|---|
| Placebo | 9.89 |
| Rovalpituzumab Tesirine/Dexamethasone | 8.80 |
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
"The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).~The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life." (NCT03033511)
Timeframe: Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Change at Week 6 | Change at Week 12 | Change at Week 18 | Change at Week 24 | Change at Week 30 | Change at Week 36 | Change at Week 42 | Change at Week 48 | Change at Week 60 | Change at Week 66 | Change at Week 78 | Change at Week Final Visit |
|---|
| Rovalpituzumab Tesirine/Dexamethasone | -4.34 | -12.13 | -19.52 | -19.39 | -16.67 | -13.33 | -3.33 | -63.33 | 0.00 | 0.00 | 0.00 | -13.31 |
Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core (EORTC QLQ-C30) Physical Functioning Domain Over Time
"The EORTC QLQ-C30 is composed of global health status/QoL scale; five functional domains (physical, role, emotional, cognitive, and social); three symptom domains (fatigue, nausea and vomiting, and pain); and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties).~The Physical Functioning domain includes 5 questions in which participants were asked to rate their overall health and overall quality of life as it relates to physical functioning during the past week on a scale from 1 (very poor) to 7 (excellent). The 5 scores were averaged and transformed to a scale from 0 to 100, where a high score represents a high QoL. A positive change from baseline indicates better quality of life." (NCT03033511)
Timeframe: Baseline, Weeks 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, Final Visit (up to Week 78)
| Intervention | score on a scale (Least Squares Mean) |
|---|
| Change at Week 6 | Change at Week 12 | Change at Week 18 | Change at Week 24 | Change at Week 30 | Change at Week 36 | Change at Week 42 | Change at Week 48 | Change at Week 54 | Change at Week 60 | Change at Week 66 | Change at Week 72 | Change at Week 78 | Change at Week Final Visit |
|---|
| Placebo | -3.97 | -1.70 | 8.15 | -0.95 | 5.33 | -13.33 | -6.67 | -6.67 | -6.67 | 0.00 | 0.00 | 0.00 | 0.00 | -4.14 |
Changes in NT-proANP
Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours (NCT03035929)
Timeframe: baseline, 24 hours, 48 hours and 72 hours
| Intervention | nmol/l (Mean) |
|---|
| Change from baseline to 24 hours | Change from baseline to 48 hours | Change from baseline to 72 hours |
|---|
| Healthy | -0.23 | 0.17 | -0.05 |
Changes in NT-proBNP
Change in natriuretic peptide levels after drug administration from baseline to 24 hours, 48 hours, and 72 hours (NCT03035929)
Timeframe: at baseline, 24 hours, 48 hours and 72 hours
| Intervention | pg/ml (Mean) |
|---|
| Change from baseline to 24 hours | Change from baseline to 48 hours | Change from baseline to 72 hours |
|---|
| Healthy | -5.0 | -23.4 | -16.9 |
Changes in NT-proANP From Baseline to 8 Hours
Change in natriuretic peptide levels after drug administration (NCT03035929)
Timeframe: baseline and 8 hours
| Intervention | nmol/l (Mean) |
|---|
| Healthy | -0.33 |
Changes in NT-proBNP From Baseline to 8 Hours
Change in natriuretic peptide levels after drug administration (NCT03035929)
Timeframe: Baseline and 8 hours
| Intervention | pg/ml (Mean) |
|---|
| Healthy | 18.4 |
First Post-Operative Opioid Administration
Time until first dose post-operative opioid administration between the study group and the control (NCT03098420)
Timeframe: baseline to 48 hrs postoperatively
| Intervention | Hours (Mean) |
|---|
| Control Group | 22.43 |
| 2mg Dexamethasone | 12.56 |
| 4mg Dexamethasone | 18.25 |
Average Opioid Consumption
Average opioid consumption 48 hrs postoperatively between the study group and the control (NCT03098420)
Timeframe: from the time of delivery to 48hrs postoperatively
| Intervention | mg of morphine equivalents (Mean) |
|---|
| Control Group | 37.93 |
| 2mg Dexamethasone | 47.11 |
| 4mg Dexamethasone | 42.38 |
Average Pain Score
Average pain score (VAS) 48 hrs postoperatively between the study group and the control. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. 0 represents no pain, whereas 10 represents unbearable pain. (NCT03098420)
Timeframe: 48 hours postoperatively
| Intervention | units on a scale (Mean) |
|---|
| Control Group | 1.49 |
| 2mg Dexamethasone | 1.40 |
| 4mg Dexamethasone | 1.62 |
Progression-free Survival at 18 Months (PFS18) Defined as the Proportion of Patients Alive and Free From Disease Progression at 18 Months From Study Entry
The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success proportion will be calculated. If patients are censored prior to 18 months post registration, a Kaplan Meier (Kaplan, E. and Meier, P., 1958) estimate for PFS18 along with the 95% confidence intervals will be reported. (NCT03202628)
Timeframe: 18 months
| Intervention | proportion of participants (Number) |
|---|
| Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT) | 0.3750 |
Percentage of Participants With Greater Than or Equal to (>=) Very Good Partial Response (VGPR) Rate
Will be estimated by the number of patients who achieve a stringent complete response (sCR), complete response CR, or VGPR divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall >= VGPR will be calculated. (NCT03202628)
Timeframe: 30 months
| Intervention | percentage of patients (Number) |
|---|
| Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT) | 25 |
Percent of Patients Alive at 30 Months
The distribution of overall survival will be estimated using the method of Kaplan-Meier. (NCT03202628)
Timeframe: 30 months
| Intervention | percentage of patients (Number) |
|---|
| Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT) | 75 |
Overall Response Rate
Will be estimated by the number of patients who achieve a stringent complete response (sCR), complete response CR, very good partial response (VGPR), or partial response (PR) divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true overall response rate will be calculated. (NCT03202628)
Timeframe: 30 months
| Intervention | percentage of patients (Number) |
|---|
| Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT) | 50 |
Number of Patients Experiencing Adverse Events Graded According to the Medical Dictionary for Regulatory Activities (MedDRA) Version (v) 12.1
The number of patients experiencing a grade 3 or greater adverse event will be reported. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. (NCT03202628)
Timeframe: 36 months
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Ixazomib, Pomalidomide, Dexamethasone, ASCT) | 7 |
Overall Survival
Overall survival is defined as the time from date of study enrollment until death from any cause. (NCT03224507)
Timeframe: From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 58 months.
| Intervention | Participants (Count of Participants) |
|---|
| KRdD Followed by Auto-HCT | 108 |
Percentage of Patients With MRD(-) Remissions at the Completion of Consolidation Therapy
The primary endpoint of MRD(-) rate, or percentage of patients with MRD(-) remissions, will be estimated along with two-sided 95% confidence interval using Clopper-Pearson exact method. Simon's optimal two-stage design will be utilized in determining the rate of MRD(-) cases. MRD assessment will be done with ClonoSEQ to identify myeloma-specific sequences. (NCT03224507)
Timeframe: Baseline until MRD(-) is reached estimated to be up to 15 months.
| Intervention | percentage of patients achieving MRD (-) (Number) |
|---|
| KRdD Followed by Auto-HCT | 81.4 |
Percentage of Patients Achieving Complete Remission Following Complete Therapy
The primary endpoint of MRD(-) rate will be estimated along with two-sided 95% confidence interval using Clopper-Pearson exact method. Simon's optimal two-stage design will be utilized in determining the rate of MRD(-) cases. MRD assessment will be done with ClonoSEQ to identify myeloma-specific sequences. Complete therapy incorporates induction and consolidation therapy. (NCT03224507)
Timeframe: Baseline up to 15 months
| Intervention | Participants (Count of Participants) |
|---|
| KRdD Followed by Auto-HCT | 106 |
Percentage of Patients That Convert From MRD(-) to MRD(+) Following Treatment Discontinuation
The primary endpoint of MRD(-) rate will be estimated along with two-sided 95% confidence interval using Clopper-Pearson exact method. Simon's optimal two-stage design will be utilized in determining the rate of MRD(-) cases. MRD assessment will be done with ClonoSEQ to identify myeloma-specific sequences. (NCT03224507)
Timeframe: Baseline to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| KRdD Followed by Auto-HCT | 23 |
Serious Adverse Events (SAEs) From the KRdD Treatment
The Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be used for this assessment. SAEs include events that are Grade 3 and above; non-serious events are Grades 1-2. (NCT03224507)
Timeframe: Baseline until the progression of disease or MRD(-) status up to an estimated 15 months.
| Intervention | Participants (Count of Participants) |
|---|
| KRdD Followed by Auto-HCT | 14 |
Progression-free Survival
Progression-free survival is defined as the interval from the start of therapy to the earliest occurrence of the following: disease progression, initiation of anti-myeloma therapy that is not an accepted maintenance therapy of lenalidomide or death from any cause. Kaplan-Meier methods will used. (NCT03224507)
Timeframe: From date of study entry until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 58 months.
| Intervention | Participants (Count of Participants) |
|---|
| KRdD Followed by Auto-HCT | 90 |
Percentage of Patients With MRD(-) Status at the Completion of Induction Therapy
The primary endpoint of MRD(-) rate will be estimated along with two-sided 95% confidence interval using Clopper-Pearson exact method. Simon's optimal two-stage design will be utilized in determining the rate of MRD(-) cases. MRD assessment will be done with ClonoSEQ to identify myeloma-specific sequences. (NCT03224507)
Timeframe: Baseline until MRD(-) status estimated at 6 months or until disease progression
| Intervention | Participants (Count of Participants) |
|---|
| KRdD Followed by Auto-HCT | 45 |
Percentage of Patients With Auto-HCT That Convert From Positive to Negative MRD
The primary endpoint of MRD(-) rate will be estimated along with two-sided 95% confidence interval using Clopper-Pearson exact method. Simon's optimal two-stage design will be utilized in determining the rate of MRD(-) cases. MRD assessment will be done with ClonoSEQ to identify myeloma-specific sequences. (NCT03224507)
Timeframe: From baseline up to an estimated 9 months
| Intervention | Participants (Count of Participants) |
|---|
| KRdD Followed by Auto-HCT | 32 |
Synergy of Panobinostat and Dexamethasone in Combination, Per Subject
Concentration of panobinostat and dexamethasone in combination leading to 90% growth inhibition of multiple myeloma cells in-vitro. The combination index (CI) is calculated using formula: CI = ([D1] in the combination / [D1] alone) + ([D2] in the combination / [D2] alone). Key: CI = 1 no synergy; CI<1 synergy; CI>1 antagonism. (NCT03256045)
Timeframe: At baseline
| Intervention | CI score (Number) |
|---|
| Subject MM-91 | Subject MM-92 | Subject MM-95 | Subject MM-96 | Subject MM-98 | Subject MM-99 | Subject MM-109 | Subject MM-111 |
|---|
| Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 1.3 | 2.6 | 1.4 | 0.6 | 1.2 | 0.9 | 4.6 | 1.2 |
Best Overall Response, by Subject
Assessed using the International Myeloma Working Group Uniform Response Criteria for Multiple Myeloma. Key: 1 = very good partial response (VGPR); 2 = partial response (PR); 3 = minimal response (MR); 4 = stable disease (SD); 5 = progressive disease (PD). Please see IC50 and CI results in the other primary outcome measures. (NCT03256045)
Timeframe: 14 months
| Intervention | IMWG Uniform Response Grade (Number) |
|---|
| Subject MM-82 | Subject MM-91 | Subject MM-92 | Subject MM-95 | Subject MM-96 | Subject MM-98 | Subject MM-99 | Subject MM-109 | Subject M-111 |
|---|
| Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 4 | 2 | 2 | 1 | 1 | 1 | 3 | 4 | 1 |
Synergy of Panobinostat and Carfilzomib in Combination, Per Subject.
Concentration of carfilzomib and panobinostat in combination leading to 90% growth inhibition of multiple myeloma cells in-vitro. The combination index (CI) is calculated using formula: CI = ([D1] in the combination / [D1] alone) + ([D2] in the combination / [D2] alone). Key: CI = 1 no synergy; CI<1 synergy; CI>1 antagonism. (NCT03256045)
Timeframe: At baseline
| Intervention | Combination index (Number) |
|---|
| Subject MM-91 | Subject MM-92 | Subject MM-95 | Subject MM-96 | Subject MM-98 | Subject MM-99 | Subject MM-109 | Subject MM-111 |
|---|
| Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 2.5 | 2.4 | 0.3 | 2.2 | 2.6 | 1.8 | 1.7 | 62.2 |
Multiple Myeloma Cells In-vitro Drug Sensitivity to Dexamethasone, by Subject
Multiple myeloma cells are added to assay with dexamethasone. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells. Results are reported in concentrations E-6. (NCT03256045)
Timeframe: At baseline
| Intervention | uM (Number) |
|---|
| Subject MM-82 | Subject MM-91 | Subject MM-95 | Subject MM-96 | Subject MM-98 | Subject MM-99 | Subject MM-109 | Subject MM-111 |
|---|
| Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 3.7 | 10.9 | 7 | 1.1 | 14.8 | 8.6 | 80 | 1.1 |
Multiple Myeloma Cells In-vitro Drug Sensitivity to Carfilzomib, by Subject
Multiple myeloma cells are added to assay with carfilzomib. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells. (NCT03256045)
Timeframe: At baseline
| Intervention | nM (Number) |
|---|
| Subject MM-82 | Subject MM-91 | Subject MM-92 | Subject MM-95 | Subject MM-96 | Subject MM-98 | Subject MM-99 | Subject MM-109 | Subject MM-111 |
|---|
| Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 17.5 | 0.479 | 0.03 | 0.269 | 0.0048 | 0.159 | 0.159 | 0.108 | 0.0152 |
Multiple Myeloma Cells In-vitro Drug Sensitivity to Panobinostat, by Subject
Multiple myeloma cells are added to assay with panobinostat. Cell viability and IC50 is determined. IC50 is the inhibitory concentration that kills 50% of cells. Results are reported in concentrations E-9. (NCT03256045)
Timeframe: At baseline
| Intervention | nM (Number) |
|---|
| Subject MM-82 | Subject MM-91 | Subject MM-92 | Subject MM-95 | Subject MM-96 | Subject MM-98 | Subject MM-99 | Subject MM-109 | Subject MM-111 |
|---|
| Chemo Assay and Treatment With Panobinostat, Carfilzomib, and Dexamethasone | 3.8 | 5.9 | 2.6 | 19.8 | 1.3 | 4.4 | 8.5 | 13.6 | 2.0 |
Discharge Criteria
Time to meet discharge criteria utilizing the modified post anesthetic discharge scoring system. The frame represents when the measurements began, i.e. 3 hours after the administration of the anesthetic block. This represents time zero, at which recording would then begin. (NCT03292926)
Timeframe: From 3 hours post-block administration on Post-operative day (POD) 0 until met discharge criteria, assessed up to 1 day
| Intervention | minutes (Mean) |
|---|
| Adductor Canal Block (ACB) | 180.67 |
| Adductor Canal Block & IPACK (ACB/IPACK) | 189.92 |
Pain While at Rest
Average numerical rating scale (NRS) at rest. A lower score is a better outcome. scale ranges from 0 to 10. (NCT03292926)
Timeframe: 24 hours post-block administration
| Intervention | score on a scale (Mean) |
|---|
| Adductor Canal Block (ACB) | 3.84 |
| Adductor Canal Block & IPACK (ACB/IPACK) | 3.95 |
Pain With Ambulation
NRS Pain score with ambulation & stairs. A lower score is a better outcome. Score range is from 0 to 10. (NCT03292926)
Timeframe: 3 hours post-block administration on Post-operative day (POD) 0
| Intervention | score on a scale (Mean) |
|---|
| NRS with Ambulation | NRS with Stairs |
|---|
| Adductor Canal Block (ACB) | 1.59 | 2.05 |
,| Adductor Canal Block & IPACK (ACB/IPACK) | 1.26 | 2.1 |
Change in European Organization for Research and Treatment of Cancer-Quality of Life (EORTC QLQ-C30) Dyspnea Score Between Baseline and Day 7
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated quality-of-life assessment for patients with cancer, consisting of 30 questions that encompass three symptom scales (pain, fatigue, and nausea/vomiting) and six questions about single symptoms, as well as five functional scales (physical, cognitive, role, emotional, and social) and one scale assessing global health status/quality of life. Each single symptoms have four response categories (1=not at all, and 4=very much). The change in EORTC fatigue score between Baseline and Day 7 were measured. Total scores using a complex scoring procedures ranges from 0 to 100 with a higher scores indicating higher fatigue. Linear model analysis was used for analysis. (NCT03367156)
Timeframe: Baseline and Day 7
| Intervention | score on a scale (Median) |
|---|
| Dexamethasone | -33.3 |
| Placebo | -33.3 |
Change in European Organization for Research and Treatment of Cancer Quality of Life (EORTC) Dyspnea Score Between Baseline and Day 14
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) is a well-validated quality-of-life assessment for patients with cancer, consisting of 30 questions that encompass three symptom scales (pain, fatigue, and nausea/vomiting) and six questions about single symptoms, as well as five functional scales (physical, cognitive, role, emotional, and social) and one scale assessing global health status/quality of life. Each single symptoms have four response categories (1=not at all, and 4=very much). The change in EORTC fatigue score between Baseline and Day 14 were measured. Total scores using a complex scoring procedures ranges from 0 to 100 with a higher scores indicating higher fatigue. Linear model analysis was used for analysis. (NCT03367156)
Timeframe: Baseline and Day 14
| Intervention | score on a scale (Median) |
|---|
| Dexamethasone | -33.3 |
| Placebo | -33.3 |
Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 14
ESAS (Edmonton Symptom Assessment Scale) is a validated scale ranging from 0 (not at all) to 10 (very much) used to assess 10 symptoms commonly experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep and feeling of well being. The change in ESAS fatigue score between Baseline and Day 14 were measured. Total ESAS fatigue score ranged from 0-10, with a higher score indicating higher fatigue. Linear model analysis was used for analysis. (NCT03367156)
Timeframe: Baseline and Day 14
| Intervention | score on a scale (Median) |
|---|
| Dexamethasone | -2 |
| Placebo | -1 |
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Intensity
The average dyspnea intensity over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea scores between Baseline and Day 7 were measured. Linear model analysis was used for analysis. (NCT03367156)
Timeframe: Baseline and Day 7
| Intervention | score on a scale (Mean) |
|---|
| Dexamethasone | -1.6 |
| Placebo | -1.6 |
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Unpleasantness
The average dyspnea unpleasantness over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea unpleasantness scores between Baseline and Day 14 were measured. Linear model analysis was used for analysis. (NCT03367156)
Timeframe: Baseline and Day 14
| Intervention | score on a scale (Median) |
|---|
| Dexamethasone | -1.7 |
| Placebo | -2.3 |
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 14 Average Intensity
The average dyspnea intensity over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea scores between Baseline and Day 14 were measured. Linear model analysis was used for analysis. (NCT03367156)
Timeframe: Baseline and Day 14
| Intervention | score on a scale (Mean) |
|---|
| Dexamethasone | -1.8 |
| Placebo | -1.9 |
Change in Edmonton Symptom Assessment Scale (ESAS) Dyspnea Score Between Baseline and Day 7
ESAS (Edmonton Symptom Assessment Scale) is a validated scale ranging from 0 (not at all) to 10 (very much) used to assess 10 symptoms commonly experienced by cancer patients during the previous 24 hours: pain, fatigue, nausea, depression, anxiety, drowsiness, dyspnea, anorexia, sleep and feeling of well being. The change in ESAS fatigue score between Baseline and Day 7 were measured. Total ESAS fatigue score ranged from 0-10, with a higher score indicating higher fatigue. Linear model analysis was used for analysis. (NCT03367156)
Timeframe: Baseline and Day 7
| Intervention | score on a scale (Median) |
|---|
| Dexamethasone | -1 |
| Placebo | -1.5 |
Change in Dyspnea Numeric Score Over the Past 24 Hours for Baseline and Day 7 Average Unpleasantness
The average dyspnea unpleasantness over the past 24 hours was assessed daily using a validated numeric rating scale from 0 to 10. The total score ranged from 0-10 where higher scores indicate worse dyspnea. The change in Dyspnea unpleasantness scores between Baseline and Day 7 were measured. Linear model analysis was used for analysis. (NCT03367156)
Timeframe: Baseline and Day 7
| Intervention | score on a scale (Mean) |
|---|
| Dexamethasone | -1.8 |
| Placebo | -2.2 |
Percentage of Participants Reporting >6.8 Reduction on the Medication Quantification Scale III
The Medication Quantification Scale (MQS) is an instrument used for clinical and research applications for quantifying medication regimen use in chronic pain populations. A 6.8 point reduction is considered equivalent to 10 morphine eqivalents. (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up
| Intervention | percentage of participants (Number) |
|---|
| One month | Three month | Six month | One year |
|---|
| Transforaminal Catheter-targeted ESI With Triamcinolone | 19 | 17 | 19 | 8 |
,| Transforaminal ESI With Dexamethasone | 16 | 20 | 15 | 7 |
Neck Disability Index-5
Percentage of patients with >30% improvement in Neck Disability Index-5 score. (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up
| Intervention | percentage of participants (Number) |
|---|
| One month | Three month | Six month | One year |
|---|
| Transforaminal Catheter-targeted ESI With Triamcinolone | 62 | 58 | 56 | 60 |
,| Transforaminal ESI With Dexamethasone | 48 | 56 | 55 | 47 |
"The Percentage of Participants Reporting Patient Global Impression of Change Score of 6-7 (Indicating Much Improved and Very Much Improved)"
"Patient Global Impression of Change is a scale which measures participant reported satisfaction after an intervention. The outcome was measured as the percent of patients reporting a PGIC score of 6-7 (indicating much improved and very much improved)" (NCT03382821)
Timeframe: 1 month, 3 month, 6 month, and 1 year follow up
| Intervention | percentage of participants (Number) |
|---|
| One month | Three months | Six months | One year |
|---|
| Transforaminal Catheter-targeted ESI With Triamcinolone | 59 | 57 | 53 | 61 |
,| Transforaminal ESI With Dexamethasone | 41 | 42 | 55 | 57 |
The Percentage of Participants With Reduction of 50% or More of Neck and Arm Pain NRS Score
The Percentage of Participants with Reduction of 50% or More of Neck and Arm Pain NRS score (NCT03382821)
Timeframe: 1 month follow up
| Intervention | percentage of participants (Number) |
|---|
| Transforaminal ESI With Dexamethasone | 49.1 |
| Interlaminar Catheter-targeted ESI With Triamcinolone | 68.5 |
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT03488225)
Timeframe: Start of treatment up to 2 years
| Intervention | Months (Median) |
|---|
| Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 24 |
Number of Participants With Minimal Residual Disease (MRD) Negativity
MRD levels continuously assessed during induction and consolidation therapy by 6-color multiparameter flow. MRD negativity defined by a value of at least 10-4 and confirmed on a second bone marrow aspiration/biopsy performed after a subsequent cycle. (NCT03488225)
Timeframe: Start of treatment up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 4 |
Event-Free Survival
Event-free survival defined as the time interval from date of treatment start until the date of death, disease progression or relapse. (NCT03488225)
Timeframe: Start of treatment up to 2 years
| Intervention | Months (Median) |
|---|
| Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 24 |
Number of Participants With Adverse Events
For the purpose of toxicity monitoring, toxicities are defined as any treatment -related grade 3 or 4 non-hematologic AEs occurred any time during the trial.NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 utilized for adverse event reporting. (NCT03488225)
Timeframe: Start of treatment up to 30 days after last dose received.
| Intervention | Participants (Count of Participants) |
|---|
| Neutropenic Fever | Peripheral Sensory Neuropathy | Allergic Reaction | Muscle Weakness |
|---|
| Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 2 | 1 | 1 | 1 |
Participants to Achieve Complete Remission (CR):
Complete Remission (CR) is defined as - Normalization of the peripheral blood and bone marrow blasts /= 100X10^9/L and complete resolution of all sites of extramedullary disease. (NCT03488225)
Timeframe: Start of treatment up to 2 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Hyper-CVAD, Inotuzumab Ozogamicin) | 4 |
>= Very Good Partial Response (VGPR) Response Percentage With Pembrolizumab Added to Ixazomib Citrate and Dexamethasone
Will be estimated by the number of patients who achieve a VGPR, complete response (CR), or stringent complete response (sCR) at any time divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success rate will be calculated. (NCT03506360)
Timeframe: Up to 9 months
| Intervention | percentage of responders (Number) |
|---|
| Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone) | 0 |
Complete Response Percentage With Pembrolizumab Added to Ixazomib Citrate and Dexamethasone
Will be estimated by the number of patients who achieve a CR or sCR at any time divided by the total number of evaluable patients. Exact binomial 95% confidence intervals for the true success rate will be calculated. (NCT03506360)
Timeframe: Up to 2 years
| Intervention | percentage of responders (Number) |
|---|
| Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone) | 0 |
Incidence of Adverse Events
Graded according National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. The maximum grade for each type of adverse event will be recorded for each patient, and frequency tables will be reviewed to determine patterns. Additionally, the relationship of the adverse event(s) to the study treatment will be taken into consideration. (NCT03506360)
Timeframe: Up to 9 months
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone) | 13 |
Overall Response Percentage
Defined as a partial response or better noted as the objective status on two consecutive evaluations. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients. Confidence intervals for the true success proportion will be calculated according to the approach of Duffy and Santner. (NCT03506360)
Timeframe: Up to 9 months
| Intervention | percentage of responders (Number) |
|---|
| Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone) | 0.077 |
Progression-free Survival
The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. (NCT03506360)
Timeframe: Up to 2 years
| Intervention | Months (Median) |
|---|
| Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone) | 1.6 |
Survival Time
The distribution of survival time will be estimated using the method of Kaplan-Meier. (NCT03506360)
Timeframe: Up to 2 years
| Intervention | Months (Median) |
|---|
| Treatment (Ixazomib Citrate, Pembrolizumab, and Dexamethasone) | 9 |
Event Free Survival (EFS) Where Events Defined as no Response, Loss of Response, or Death
"Time from date of treatment start until the date of first objective documentation of disease-relapse. Relapse and resistant disease will be defined based on morphological assessment of bone marrow and peripheral blood.~Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above, and platelet count of 100 x 10^9/L. Complete resolution of all sites of extramedullary disease is required for CR.~Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets < 100 x 10^9/L; neutrophils < 1 x 10^9/L).~Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts." (NCT03518112)
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 month
| Intervention | Months (Median) |
|---|
| Treatment (Blinatumomab, Combination Chemotherapy) | 5.7 |
Duration of Response
"Response date to loss of response or last follow up. Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above, and platelet count of 100 x 10^9/L. Complete resolution of all sites of extramedullary disease is required for CR.~Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets < 100 x 10^9/L; neutrophils < 1 x 10^9/L).~Partial Response (PR): As above for CR except for the presence of 6-25% marrow blasts." (NCT03518112)
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 month
| Intervention | Months (Median) |
|---|
| Treatment (Blinatumomab, Combination Chemotherapy) | 4.4 |
Participants With a Response
"defined as the percentage of patients achieving complete response (CR) or CR with inadequate count recovery (CRi). Complete Remission (CR): Normalization of the peripheral blood and bone marrow with 5% or less blasts in normocellular or hypercellular marrow with a granulocyte count of 1 x 10^9/L or above, and platelet count of 100 x 10^9/L. Complete resolution of all sites of extramedullary disease is required for CR.~Complete remission without recovery of counts (CRi): Peripheral blood and marrow results as for CR, but with incomplete recover of counts (platelets < 100 x 10^9/L; neutrophils < 1 x 10^9/L)." (NCT03518112)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Blinatumomab, Combination Chemotherapy) | 4 |
Overall Survival
Time from date of treatment start until date of death due to any cause or last Follow-up. (NCT03518112)
Timeframe: Time from the first day of treatment assessed up to 3 years, 1 month
| Intervention | Months (Median) |
|---|
| Treatment (Blinatumomab, Combination Chemotherapy) | 16.7 |
Number of Participants Negative for Minimal Residual Disease (MRD)
Minimal Residual Disease (MRD) was assessed by flow cytometry. MRD negativity: Absence of detectable leukemia using multiparameter flow cytometry with a sensitivity of NCT03518112)
Timeframe: Up to 3 years
| Intervention | Participants (Count of Participants) |
|---|
| Treatment (Blinatumomab, Combination Chemotherapy) | 4 |
Macular Thickness at 3 Days After Intravitreous Dexamethasone
Measure macular thickness at 3 days after intravitreous dexamethasone with OCT - unit µm (NCT03608839)
Timeframe: Three days after intravitreous dexamethasone
| Intervention | µm (Mean) |
|---|
| 0,01ml Dexamethasone Solution | 438.44 |
| 0,03 ml Dexamethasone Solution | 465.22 |
| 0,05 ml Dexamethasone Solution | 368.22 |
Macular Thickness at 28 Days After Intravitreous Dexamethasone
Measure macular thickness at 28 days after intravitreous dexamethasone with OCT - unit µm (NCT03608839)
Timeframe: 28 days after intravitreous dexamethasone
| Intervention | µm (Mean) |
|---|
| 0,01ml Dexamethasone Solution | 554.66 |
| 0,03 ml Dexamethasone Solution | 617.22 |
| 0,05 ml Dexamethasone Solution | 451.44 |
Best Corrected Visual Acuity (BCVA) at 3 Days After Intravitreous Dexamethasone
Measure best corrected visual acuity (BCVA) at 3 days after intravitreous dexamethasone with ETDRS chart (NCT03608839)
Timeframe: Three days after intravitreous dexamethasone
| Intervention | ETDRS Letters (Mean) |
|---|
| 0,01ml Dexamethasone Solution | 54.22 |
| 0,03 ml Dexamethasone Solution | 52.33 |
| 0,05 ml Dexamethasone Solution | 60.22 |
Best Corrected Visual Acuity (BCVA) at 28 Days After Intravitreous Dexamethasone
Measure best corrected visual acuity (BCVA) at 28 days after intravitreous dexamethasone with ETDRS chart (NCT03608839)
Timeframe: 28 days after intravitreous dexamethasone
| Intervention | ETDRS letters (Mean) |
|---|
| 0,01ml Dexamethasone Solution | 58.33 |
| 0,03 ml Dexamethasone Solution | 50.55 |
| 0,05 ml Dexamethasone Solution | 64.11 |
Intraocular Pressure (IOP) at 3 Days After Intravitreous Dexamethasone
Measure intraocular pressure (IOP) 3 days after intravitreous dexamethasone - unit mmHg (NCT03608839)
Timeframe: 3 days after intravitreous dexamethasone
| Intervention | mmHg (Mean) |
|---|
| 0,01ml Dexamethasone Solution | 12.33 |
| 0,03 ml Dexamethasone Solution | 13.11 |
| 0,05 ml Dexamethasone Solution | 12.44 |
Intraocular Pressure (IOP) at 28 Days After Intravitreous Dexamethasone
Measure intraocular pressure (IOP) 28 days intravitreous dexamethasone - unit mmHg (NCT03608839)
Timeframe: 28 days after intravitreous dexamethasone
| Intervention | mmHg (Mean) |
|---|
| 0,01ml Dexamethasone Solution | 12.33 |
| 0,03 ml Dexamethasone Solution | 12.44 |
| 0,05 ml Dexamethasone Solution | 11.88 |
Number of Participants Requiring Second Dose of Dexamethasone
Reason for patient needing a second dose of dexamethasone; such as spit dose up or vomiting dose (NCT03705273)
Timeframe: 1 hour
| Intervention | Participants (Count of Participants) |
|---|
| Dexamethasone Tablets | 0 |
| Dexamethasone IV for PO | 0 |
Number of Participants With Nausea
Presence of nausea after medication administration (yes/no) measured by participant self-report (NCT03705273)
Timeframe: 1 hour
| Intervention | Participants (Count of Participants) |
|---|
| Dexamethasone Tablets | 3 |
| Dexamethasone IV for PO | 0 |
Total Ocular Symptoms Score (TOSS)
The TOSS is a patient-reported evaluation in the TOSS Questionnaire of 3 ocular symptoms: itching/burning, hyperemia of conjunctiva and tearing. A score was given in the presence of symptoms: 0 = none, 1 = mild, 2 = moderate, 3 = severe. (NCT03739528)
Timeframe: Day 4, 8, 15
| Intervention | score on a scale (Mean) |
|---|
| Visit 3 - Day 4 | Visit 4 - Day 8 | Visit 5 - Day 15 |
|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 0.29 | 0.28 | 0.17 |
,| Tobramycin + Dexamethasone | 0.37 | 0.26 | 0.17 |
Ocular Pain/Discomfort: 4-point Scale
Overall ocular pain and discomfort was evaluated by the subject on a 4-point scale (0 = absent, 1 = mild, 2 = moderate, 3 = severe). (NCT03739528)
Timeframe: Day 4, 8, 15
| Intervention | Participants (Count of Participants) |
|---|
| Visit 3 - Day 4: Presence/absence of ocular pain72467252 | Visit 3 - Day 4: Presence/absence of ocular pain72467251 | Visit 4 - Day 8: Presence/absence of ocular pain72467251 | Visit 4 - Day 8: Presence/absence of ocular pain72467252 | Visit 5 - Day 15: Presence/absence of ocular pain72467252 | Visit 5 - Day 15: Presence/absence of ocular pain72467251 |
|---|
| Score=0 | Score>0 |
|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 360 |
| Tobramycin + Dexamethasone | 361 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 35 |
| Tobramycin + Dexamethasone | 32 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 366 |
| Tobramycin + Dexamethasone | 366 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 29 |
| Tobramycin + Dexamethasone | 27 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 377 |
| Tobramycin + Dexamethasone | 373 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 18 |
| Tobramycin + Dexamethasone | 20 |
Visual Acuity
"Visual acuity was assessed as per local clinical practice, i.e. with the Snellen (feet) or the ETDRS (meter) chart. Visual acuity was then analysed using decimal unit. Decimal score is the decimal expression of the Snellen (feet) or the ETDRS (meter) charts in which the numerator indicates the distance from the chart and the denominator indicates the size of the smallest line that can be read. Decimal values were provided directly from the investigator or computed as a result of the Snellen or ETDRS fraction.~Generally decimal values from 0.01 to 0.10 indicate severe vision loss; decimal values from 0.125 to 0.25 indicate moderate vision loss; decimal values from 0.32 to 0.63 indicate mild vision loss; decimal values from 0.8 to 1.6 indicate normal vision.~Lower decimal values correspond to a reduced visual acuity and worst outcomes, while higher decimal values indicate an improved visual acuity and better outcomes." (NCT03739528)
Timeframe: At day 0 (screening) and at day 15
| Intervention | decimal score (Mean) |
|---|
| Visit 1 - Screening | Visit 5 - Day 15 |
|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 0.41 | 0.88 |
,| Tobramycin + Dexamethasone | 0.41 | 0.89 |
Adverse Events
Adverse events were described according to System Organ Classes (SOC) and Preferred Terms (PT) using the Medical Dictionary for Regulatory Activities (MedDRA) and were presented by treatment group. (NCT03739528)
Timeframe: During all the treatment until day 15
| Intervention | Participants (Count of Participants) |
|---|
| Patients with TEAEs | Patients with serious TEAEs | Patients with TEAEs suspected to be study related | Patients with TEAEs leading to discontinuation | Patients with fatal TEAEs | Patients with severe TEAEs |
|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 56 | 4 | 26 | 4 | 1 | 3 |
,| Tobramycin + Dexamethasone | 51 | 2 | 26 | 3 | 0 | 0 |
Number of Participants Without Signs of Anterior Ocular Chamber Inflammation
Number of participants without signs of anterior chamber inflammation (sum of cells and flare score = 0). (NCT03739528)
Timeframe: Day 0 (screening), 4, 8
| Intervention | Participants (Count of Participants) |
|---|
| Visit 1 - Screening72467251 | Visit 1 - Screening72467252 | Visit 3 - Day 472467252 | Visit 3 - Day 472467251 | Visit 4 - Day 872467252 | Visit 4 - Day 872467251 |
|---|
| Number of participants without signs | Number of participants with signs |
|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 395 |
| Tobramycin + Dexamethasone | 393 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 0 |
| Tobramycin + Dexamethasone | 0 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 289 |
| Tobramycin + Dexamethasone | 302 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 106 |
| Tobramycin + Dexamethasone | 91 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 338 |
| Tobramycin + Dexamethasone | 341 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 57 |
| Tobramycin + Dexamethasone | 52 |
Burning, Stinging, Blurred Vision
Burning, stinging, blurred vision were evaluated on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe. (NCT03739528)
Timeframe: Day 4, 8, 15
| Intervention | score on a scale (Mean) |
|---|
| Burning: visit 3 - day 4 | Burning: visit 4 - day 8 | Burning: visit 5 - day 15 | Stinging: visit 3 - day 4 | Stinging: visit 4 - day 8 | Stinging: visit 5 - day 15 | Blurred vision: visit 3 - day 4 | Blurred vision: visit 4 - day 8 | Blurred vision: visit 5 - day 15 |
|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 0.08 | 0.06 | 0.07 | 0.05 | 0.07 | 0.06 | 0.06 | 0.06 | 0.03 |
,| Tobramycin + Dexamethasone | 0.09 | 0.11 | 0.07 | 0.04 | 0.07 | 0.04 | 0.05 | 0.04 | 0.01 |
Global Evaluation of Local Tolerability
Global evaluation was evaluated on a 4-point scale: 0 = no intolerability, 1 = mild intolerability, 2 = moderate intolerability, 3 = maximum intolerability. (NCT03739528)
Timeframe: Day 4, 8, 15
| Intervention | score on a scale (Mean) |
|---|
| Visit 3 - Day 4 | Visit 4 - Day 8 | Visit 5 - Day 15 |
|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 0.03 | 0.01 | 0.02 |
,| Tobramycin + Dexamethasone | 0.01 | 0.03 | 0.02 |
Conjunctival Hyperemia
Conjunctival hyperemia was evaluated with slit lamp and results provided as a score as follows: 0 = absence of inflammation, 1 = mild inflammation (some vessels injected), 2 = moderate inflammation (diffuse injection of vessels, but individual vessels are still discernable) 3 = severe inflammation (intense injection of vessels, individual vessels not easily discernable). (NCT03739528)
Timeframe: Day 4, 8, 15
| Intervention | Participants (Count of Participants) |
|---|
| Visit 3 - Day 472467252 | Visit 3 - Day 472467251 | Visit 4 - Day 872467251 | Visit 4 - Day 872467252 | Visit 5 - Day 1572467252 | Visit 5 - Day 1572467251 |
|---|
| Score>0 | Score=0 |
|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 337 |
| Tobramycin + Dexamethasone | 323 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 58 |
| Tobramycin + Dexamethasone | 70 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 348 |
| Tobramycin + Dexamethasone | 358 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 47 |
| Tobramycin + Dexamethasone | 35 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 371 |
| Tobramycin + Dexamethasone | 375 |
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 24 |
| Tobramycin + Dexamethasone | 18 |
Intraocular Pressure (IOP)
IOP is measured using a tonometer. IOP is measured as mmHg; normal intraocular pressures average between 12-22 mm Hg. (NCT03739528)
Timeframe: At day 0 (screening) and at day 4, 8, 15
| Intervention | mmHg (Mean) |
|---|
| Visit 1 - Screening | Visit 3 - Day 4 | Visit 4 - Day 8 | Visit 5 - Day 15 |
|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 15.16 | 14.26 | 14.29 | 14.45 |
,| Tobramycin + Dexamethasone | 15.12 | 14.49 | 14.45 | 14.37 |
Number of Participants With Endophthalmitis
The number of participants with endophthalmitis after administration of study treatment in the study was assessed and reported. Diagnosis of endophthalmitis is based on clinical evaluation of signs and symptoms (such as swollen eyelids, ocular pain, conjunctival hyperemia, decreased visual acuity, opaque vitreous) through slit lamp examination, and microbiological tests on conjunctival or corneal swabs. (NCT03739528)
Timeframe: Day 4, 8, 15
| Intervention | Participants (Count of Participants) |
|---|
| Visit 3 - Day 4: no diagnosis of endophthalmitis | Visit 4 - Day 8: no diagnosis of endophthalmitis | Visit 5 - Day 15: no diagnosis of endophthalmitis |
|---|
| Levofloxacin + Dexamethasone Followed by Dexamethasone | 393 | 391 | 389 |
,| Tobramycin + Dexamethasone | 393 | 393 | 391 |
Safety Tolerability: Number of Ocular and Non-ocular TEAEs
Treatment-emergent adverse events summarized at the subject level by system organ class and preferred term are available in the Adverse Events module. Data reported in the table below corresponds to the total number of participants with ocular and non-ocular treatment-emergent adverse events (TEAEs). (NCT03739593)
Timeframe: Up to 6 months treatment duration
| Intervention | participants (Number) |
|---|
| Initial Phase: AR-1105-CF1 | 5 |
| Randomization Phase: AR-1105-CF1 | 22 |
| Randomization Phase: AR-1105-CF2 | 22 |
Aqueous Humour Concentration of Levofloxacin
Defined as the concentration of levofloxacin into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of levofloxacin has been measured by LC tandem mass spectrometry. (NCT03740659)
Timeframe: 90±15 min after the first administration of the study treatments
| Intervention | nmol/mL (Mean) |
|---|
| Levofloxacin + Dexamethasone | 1.970 |
| Levofloxacin | 2.151 |
| Dexamethasone | 0 |
Aqueous Humour Concentration of Dexamethasone 21-phosphate
Defined as the concentration of dexamethasone 21-phosphate into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin. The concentration of dexamethasone 21-phosphate has been measured by LC tandem mass spectrometry. (NCT03740659)
Timeframe: 90±15 min after the first administration of the study treatments
| Intervention | nmol/mL (Mean) |
|---|
| Levofloxacin + Dexamethasone | 0 |
| Levofloxacin | 0 |
| Dexamethasone | 0 |
Aqueous Humour Concentration of Dexamethasone
Defined as the concentration of dexamethasone into the aqueous humour in all the three arms: Levofloxacin + Dexamethasone, Dexamethasone and Levofloxacin.The concentration of dexamethasone has been measured by LC tandem mass spectrometry. (NCT03740659)
Timeframe: 90±15 min after the first administration of the study treatments
| Intervention | nmol/mL (Mean) |
|---|
| Levofloxacin + Dexamethasone | 0.030 |
| Levofloxacin | 0 |
| Dexamethasone | 0.042 |
Analgesia Duration
The investigator would like to investigate if the dexamethasone given IV or with the nerve block in young patients undergoing lower limb surgery produces the same duration of analgesia. (NCT03855059)
Timeframe: 24 - 48 hours
| Intervention | Hours (Mean) |
|---|
| Intervenous Steroid | 22.1 |
| Perineural Steroid | 25.7 |
Number of Participants With Anti-Daratumumab Antibodies
Number of participants who test positive for anti-daratumumab antibodies were reported. This outcome measure was planned to be analyzed for specified arm only. (NCT03871829)
Timeframe: Up to end of study; up to 30.3 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 0 |
Serum Concentrations of Daratumumab
Serum concentrations of daratumumab were assessed. This outcome measure was planned to be analyzed for specified arm only. (NCT03871829)
Timeframe: Day 1 of Cycles 1, 3, and 7 (each cycle of 28 days) and Follow Up (post treatment Week 8; up to 30.3 months)
| Intervention | microgram per milliliters (mcg/mL) (Mean) |
|---|
| Cycle 1 Day 1 | Cycle 3 Day 1 | Cycle 7 Day 1 | Post-treatment Week 8 |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 39.1 | 849 | 715 | 85.5 |
Time to Next Treatment
Time to next treatment was defined as the time from randomization to the start of the next-line treatment. (NCT03871829)
Timeframe: Up to 3 years and 7 months
| Intervention | months (Median) |
|---|
| Arm A: Carfilzomib+Dexamethasone (Kd) | 20.60 |
| Arm B: Dara-SC in Combination With Kd (DKd) | 20.14 |
Progression Free Survival (PFS)
PFS was defined as the duration from the date of randomization to either progressive disease (PD) or death, whichever comes first. IMWG criteria for PD: >=25% from lowest response level in serum M-component (the absolute increase must be >=0.5 gram per deciliter [g/dL]) and/or in urine M-component (the absolute increase must be >=200 mg/24 hour); only in participants without measurable serum and urine M-protein levels: increase of >=25% in the difference between involved and uninvolved free light chain levels and the absolute increase must be >10 mg/dL. BMPC%: the absolute % must be >=10%; definite increase in size of existing bone lesions or soft tissue plasmacytomas; definite development of new bone lesions or soft tissue plasmacytomas; development of hypercalcemia (corrected serum calcium >11.5 milligrams per deciliter (mg/dL) or 2.65 millimoles per liter [mmol/L]) that can be attributed solely to PC proliferative disorder. (NCT03871829)
Timeframe: Up to 3 years and 7 months
| Intervention | months (Median) |
|---|
| Arm A: Carfilzomib+Dexamethasone (Kd) | 10.61 |
| Arm B: Dara-SC in Combination With Kd (DKd) | 10.74 |
Percentage of Participants With Negative Minimal Residual Disease (MRD)
Percentage of participants with negative MRD were reported. MRD negativity rate, defined as the percentage of participants who had MRD negative status at 10^-5 by bone marrow aspirate after the date of randomization and prior to PD or subsequent anti-myeloma therapy. (NCT03871829)
Timeframe: Up to 3 years and 7 months
| Intervention | Percentage of participants (Number) |
|---|
| Arm A: Carfilzomib+Dexamethasone (Kd) | 11.4 |
| Arm B: Dara-SC in Combination With Kd (DKd) | 6.8 |
Percentage of Participants Achieving Very Good Partial Response (VGPR) or Better Response
Percentage of participants achieving VGPR or better response were reported. VGPR or better rate was defined as the percentage of participants achieving VGPR, complete response (CR), or stringent complete response (sCR) in accordance with the International Myeloma Working Group (IMWG) criteria, during or after the study treatment but before the start of subsequent anti-myeloma therapy. IMWG criteria for VGPR: Serum and urine M-component detectable by immunofixation but not on electrophoresis, or greater than or equal to (>=) 90 percent (%) reduction in serum M-protein plus urine M-protein less than (<) 100 milligram (mg)/24 hours; for CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas (PCs), and <5% PCs in bone marrow; for sCR: CR plus normal free light chain (FLC) ratio, and Absence of clonal PCs by immunohistochemistry, immunofluorescence or 2- to 4- color flow cytometry. (NCT03871829)
Timeframe: Up to 3 years and 4 months
| Intervention | Percentage of participants (Number) |
|---|
| Arm A: Carfilzomib+Dexamethasone (Kd) | 46.2 |
| Arm B: Dara-SC in Combination With Kd (DKd) | 48.8 |
Percentage of Participants Achieving Complete Response (CR) or Better
Percentage of participants achieving CR or better were reported. CR or better rate was defined as the percentage of participants achieving CR or sCR based on the computerized algorithm, according to IMWG response criteria. IMWG criteria for CR: Negative immunofixation on the serum and urine, and Disappearance of any soft tissue plasmacytomas (PCs), and <5% PCs in bone marrow. (NCT03871829)
Timeframe: Up to 3 years and 7 months
| Intervention | Percentage of participants (Number) |
|---|
| Arm A: Carfilzomib+Dexamethasone (Kd) | 25.6 |
| Arm B: Dara-SC in Combination With Kd (DKd) | 12.2 |
Overall Survival (OS)
OS was defined as the time from the date of randomization to the date of the participant's death due to any cause. (NCT03871829)
Timeframe: Up to 3 years and 7 months
| Intervention | months (Median) |
|---|
| Arm A: Carfilzomib+Dexamethasone (Kd) | NA |
| Arm B: Dara-SC in Combination With Kd (DKd) | NA |
Overall Response Rate (ORR)
ORR was defined as the percentage of participants who achieved partial response (PR) or better responses based on the computerized algorithm, in accordance with the IMWG criteria, during or after the study treatment but before the start of subsequent anti-myeloma therapy. IMWG criteria for PR: greater than or equal to (>=)50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by >=90% or less than (<)200 mg/24 hours; If the serum and urine M-protein were not measurable, a decrease of >=50% in the difference between involved and uninvolved free light chain (FLC) levels was required in place of the M-protein criteria; If serum and urine M-protein were not measurable, and serum free light assay is also not measurable, >=50% reduction in bone marrow plasma cells (PCs) was required in place of M-protein, provided baseline bone marrow plasma cell percentage was >=30%; additionally, if present at baseline, >=50% reduction in the size of soft tissue PCs was also required. (NCT03871829)
Timeframe: Up to 3 years and 7 months
| Intervention | Percentage of participants (Number) |
|---|
| Arm A: Carfilzomib+Dexamethasone (Kd) | 64.1 |
| Arm B: Dara-SC in Combination With Kd (DKd) | 75.6 |
Number of Participants With Anti-recombinant Human Hyaluronidase (rHuPH20) Antibodies
The incidence of anti-rHuPH20 antibodies were summarized for all participants who received at least one dose of Dara-SC and had appropriate plasma samples for detection of antibodies to rHuPH20 (at least 1 sample after the start of the first dose of Dara-SC). This outcome measure was planned to be analyzed for specified arm only. (NCT03871829)
Timeframe: Up to end of study; up to 30.3 months
| Intervention | Participants (Count of Participants) |
|---|
| Arm B: Dara-SC in Combination With Kd (DKd) | 1 |
Percentage of Eyes With Anterior Chamber Cell Grade 0
Of eyes with a record at postoperative day 8, percentage with anterior chamber cell grade 0. Cells in the anterior chamber of the eye are indicative of intraocular inflammation and are evaluated using a slit-lamp biomicroscope; a grade of 0 indicates that no inflammatory cells were visible in a 1 mm by 1 mm slit beam. (NCT04290676)
Timeframe: Postoperative day 8
| Intervention | percentage of eyes (Number) |
|---|
| DEXYCU (Dexamethasone Intraocular Suspension) 9% | 65 |
Patients Needing Drug Dose Adjustment
Patients who needed dose adjustment of any of the drugs involved in the treatment protocol (NCT04425863)
Timeframe: 14 days
| Intervention | Participants (Count of Participants) |
|---|
| Mild Cases | 0 |
| Moderate Cases | 0 |
| Severe Cases | 0 |
Patients Who Improved Their Condition or Did Not Worsen it
Number of patients who did not go to a more severe stage of disease or die (i.e. they neither go from mild to moderate or severe, nor go from moderate to severe or die, if they had been already enrolled in a severe condition) (NCT04425863)
Timeframe: 7 days
| Intervention | Participants (Count of Participants) |
|---|
| Mild Cases | 135 |
| Moderate Cases | 12 |
| Severe Cases | 19 |
Mortality
Patients who died within 30 days after enrollment (NCT04425863)
Timeframe: 30 days
| Intervention | Participants (Count of Participants) |
|---|
| Mild Cases | 0 |
| Moderate Cases | 0 |
| Severe Cases | 1 |
ICU-treated Patients After 2-week Treatment
Number of patients needing ICU-treatment including mechanical ventilation after 2-week treatment (NCT04425863)
Timeframe: 14 days
| Intervention | Participants (Count of Participants) |
|---|
| Mild Cases | 0 |
| Moderate Cases | 0 |
| Severe Cases | 2 |
Adverse Events
Patient presenting serious adverse events (NCT04425863)
Timeframe: 14 days
| Intervention | Participants (Count of Participants) |
|---|
| Mild Cases | 0 |
| Moderate Cases | 0 |
| Severe Cases | 1 |
Mean Change From Baseline in Oral Pain Scores on the Visual Analog Scale (VAS) at 4 Weeks
Oral Pain Scores were measured on the Visual Analog Scale (VAS), the score ranges from 0-10, zero indicating no pain and 10 indicating the worst pain. The pain score measured on a VAS scale will be compared between group A and group B to detect any significant differences pre and post treatment at 4 weeks. (NCT04540133)
Timeframe: 4 weeks
| Intervention | score on a scale (Mean) |
|---|
| Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | 6.3 |
| Dexamethasone 0.5mg/5ml Solution (Arm B) | 4.4 |
Mean Change From Baseline in Reticulation/Keratosis, Erythema, and Ulceration (REU) Scores at 4 Weeks
Oral lesions were scored using the REU (reticulation,erythema and ulcer) system (form 0 till 49.5). Reticulations were scored from 0 to 1 (0 = no white striations, 1 = presence of white striations or keratotic papules); erythematous lesions from 0 to 3 by area of involvement (0 = no lesion, 1 = lesions less than 1 cm2, 2 = lesions from 1 to 3 cm2, 3 = lesions greater than 3 cm2); ulcers from 0 to 3 by area of involvement. The higher is the score the more severe is the disease. In order to evaluate the clinical improvement in clinician-reported outcome measures for oral lesions, REU scores within the compound dexamethasone solution in Mucolox™ group (Arm A) will be compared to that in the dexamethasone solution only group (Arm B). The REU scores will be summarized descriptively for each arm at pre-treatment, post-treatment, and pre-to-post treatment change. The pre-to-post treatment change will be compared between the arms using either student's t-test o (NCT04540133)
Timeframe: 4 weeks
| Intervention | score on a scale (Mean) |
|---|
| Dexamethasone 0.5mg/5ml Solution in Mucolox™ (Group A) | 2.5 |
| Dexamethasone 0.5mg/5ml Solution (Arm B) | 3.2 |
Number of Participants That Developed Clinically Significant Hyperglycemia
Defined as need for insulin drip or ICU admission to control hyperglycemia (NCT04834375)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dexamethasone Dose | 5 |
| Weight-based Dexamethasone Dose | 4 |
Number of Participants Admitted to the ICU
Number of participants that required admission to the ICU (NCT04834375)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dexamethasone Dose | 27 |
| Weight-based Dexamethasone Dose | 12 |
Days of Stay in the Intensive Care Unit
ICU length of stay (NCT04834375)
Timeframe: 28 days
| Intervention | days (Mean) |
|---|
| Standard Dexamethasone Dose | 15.33 |
| Weight-based Dexamethasone Dose | 11.33 |
Duration of Invasive Mechanical Ventilation
Total days requiring invasive mechanical ventilation (NCT04834375)
Timeframe: 28 days
| Intervention | days (Mean) |
|---|
| Standard Dexamethasone Dose | 19.95 |
| Weight-based Dexamethasone Dose | 10.90 |
Days of Hospitalization
Duration of hospitalization (NCT04834375)
Timeframe: 28 days
| Intervention | days (Mean) |
|---|
| Standard Dexamethasone Dose | 14.83 |
| Weight-based Dexamethasone Dose | 11.56 |
All Cause Mortality at 28 Days
"All cause mortality at 28 days.~Comment: Primary outcome was all cause mortality at 28 days but the patients were followed until end of admission for the final disposition (death or discharge) which accounts for the differences in the primary outcome of mortality at 28 days and the total number of deaths at discharge" (NCT04834375)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dexamethasone Dose | 15 |
| Weight-based Dexamethasone Dose | 12 |
Number of Participants That Required Oxygen Supplementation a Discharge From the Hospital
"Need for oxygen supplementation at hospital discharge~Comment: Corrected total number of discharged patients alive to 55 in the Standard Dexamethasone Dose Arm." (NCT04834375)
Timeframe: Until hospital discharge
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dexamethasone Dose | 25 |
| Weight-based Dexamethasone Dose | 27 |
Number of Participants That Required Invasive Mechanical Ventilation
Escalation to invasive mechanical ventilation (NCT04834375)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dexamethasone Dose | 19 |
| Weight-based Dexamethasone Dose | 10 |
Number of Participants That Required Higher Levels of Oxygen Supplementation
Venturi mask, Non-rebreather mask, High-flow nasal cannula, Non-invasive ventilation (NCT04834375)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dexamethasone Dose | 32 |
| Weight-based Dexamethasone Dose | 31 |
Number of Participants That Required ECMO
Refractory hypoxemia requiring ECMO (NCT04834375)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dexamethasone Dose | 3 |
| Weight-based Dexamethasone Dose | 2 |
Number of Participants That Developed Secondary Bacterial or Fungal Infections
Culture positive evidence of secondary bacterial or fungal infections (NCT04834375)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dexamethasone Dose | 19 |
| Weight-based Dexamethasone Dose | 9 |
Number of Participants That Required Tracheostomy
Need for tracheostomy (NCT04834375)
Timeframe: 28 days
| Intervention | Participants (Count of Participants) |
|---|
| Standard Dexamethasone Dose | 5 |
| Weight-based Dexamethasone Dose | 1 |
Ease of Insertion
Rated as Easy, Moderate, Difficult (NCT05372315)
Timeframe: Day 0
| Intervention | Participants (Count of Participants) |
|---|
| Easy | Moderate | Difficult |
|---|
| Lower Punctum Insertion (Group 1) | 36 | 2 | 1 |
,| Upper Punctum Insertion (Group 2) | 36 | 4 | 0 |
Attempts to Achieve Successful Insertion
Number of attempts to insert the dexamethasone insert in the upper or lower punctum. (NCT05372315)
Timeframe: Day 0
| Intervention | Participants (Count of Participants) |
|---|
| One Attempt | Two Attempts |
|---|
| Lower Punctum Insertion (Group 1) | 38 | 1 |
,| Upper Punctum Insertion (Group 2) | 35 | 5 |