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thalidomide and Encephalopathy, Toxic

thalidomide has been researched along with Encephalopathy, Toxic in 12 studies

Thalidomide: A piperidinyl isoindole originally introduced as a non-barbiturate hypnotic, but withdrawn from the market due to teratogenic effects. It has been reintroduced and used for a number of immunological and inflammatory disorders. Thalidomide displays immunosuppressive and anti-angiogenic activity. It inhibits release of TUMOR NECROSIS FACTOR-ALPHA from monocytes, and modulates other cytokine action.
thalidomide : A racemate comprising equimolar amounts of R- and S-thalidomide.
2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione : A dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group.

Research Excerpts

ExcerptRelevanceReference
"Thalidomide is remarkably active in advanced relapsed and refractory multiple myeloma (MM), so that its use has been recently proposed either in newly diagnosed patients or as maintenance treatment after conventional or high-dose therapy."9.11Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma. ( Baccarani, M; Cangini, D; Cavo, M; Cellini, C; Pastorelli, F; Perrone, G; Plasmati, R; Tacchetti, P; Tosi, P; Tura, S; Zamagni, E, 2005)
"We analyzed DNA from 1,495 patients with multiple myeloma."5.37Genetic factors underlying the risk of thalidomide-related neuropathy in patients with multiple myeloma. ( Child, JA; Corthals, SL; Davies, FE; Dickens, NJ; Durie, BG; Goldschmidt, H; Gregory, WM; Johnson, DC; Lokhorst, HM; Morgan, GJ; Ross, FM; Sonneveld, P; Van Ness, B; Walker, BA, 2011)
"Thalidomide is remarkably active in advanced relapsed and refractory multiple myeloma (MM), so that its use has been recently proposed either in newly diagnosed patients or as maintenance treatment after conventional or high-dose therapy."5.11Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma. ( Baccarani, M; Cangini, D; Cavo, M; Cellini, C; Pastorelli, F; Perrone, G; Plasmati, R; Tacchetti, P; Tosi, P; Tura, S; Zamagni, E, 2005)
"2 years) underwent clinical and neurophysiologic assessment at baseline and at 2 (8 patients, group A) or 5 years (11 patients, group B) after starting lenalidomide therapy for relapsed/refractory multiple myeloma."3.83Lenalidomide long-term neurotoxicity: Clinical and neurophysiologic prospective study. ( Barilà, G; Berno, T; Briani, C; Cacciavillani, M; Campagnolo, M; Dalla Torre, C; De March, E; Ermani, M; Lico, A; Lucchetta, M; Salvalaggio, A; Zambello, R, 2016)
"Thalidomide was used for graft-vs-host disease, pyoderma gangrenosum, and discoid lupus with dosages ranging from 100 to 1,200 mg/day for 5 to 16 months (cumulative dosages of 24 to 384 g)."2.70Thalidomide-induced neuropathy. ( Chaudhry, V; Cornblath, DR; Corse, A; Freimer, M; Simmons-O'Brien, E; Vogelsang, G, 2002)
" However, soon after their introduction into clinical practice, chemotherapy-induced peripheral neurotoxicity (CIPN) emerged as their main non-hematological and among dose-limiting adverse events."2.61Vinca alkaloids, thalidomide and eribulin-induced peripheral neurotoxicity: From pathogenesis to treatment. ( Alberti, P; Argyriou, AA; Islam, B; Kolb, N; Lustberg, M; Staff, NP, 2019)
" Depending on dosage and agent used symptoms resolve completely or not."2.42[Neurotoxic effects of medications: an update]. ( Arné-Bès, MC, 2004)
"We analyzed DNA from 1,495 patients with multiple myeloma."1.37Genetic factors underlying the risk of thalidomide-related neuropathy in patients with multiple myeloma. ( Child, JA; Corthals, SL; Davies, FE; Dickens, NJ; Durie, BG; Goldschmidt, H; Gregory, WM; Johnson, DC; Lokhorst, HM; Morgan, GJ; Ross, FM; Sonneveld, P; Van Ness, B; Walker, BA, 2011)

Research

Studies (12)

TimeframeStudies, this research(%)All Research%
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's7 (58.33)29.6817
2010's5 (41.67)24.3611
2020's0 (0.00)2.80

Authors

AuthorsStudies
Islam, B1
Lustberg, M1
Staff, NP1
Kolb, N1
Alberti, P1
Argyriou, AA1
Mahony, C1
McMenemy, S1
Rafipay, AJ1
Beedie, SL1
Fraga, LR1
Gütschow, M1
Figg, WD1
Erskine, L1
Vargesson, N1
Dalla Torre, C1
Zambello, R1
Cacciavillani, M1
Campagnolo, M1
Berno, T1
Salvalaggio, A1
De March, E1
Barilà, G1
Lico, A1
Lucchetta, M1
Ermani, M2
Briani, C3
Johnson, DC1
Corthals, SL1
Walker, BA1
Ross, FM1
Gregory, WM1
Dickens, NJ1
Lokhorst, HM1
Goldschmidt, H1
Davies, FE1
Durie, BG1
Van Ness, B1
Child, JA1
Sonneveld, P1
Morgan, GJ1
Chaudhry, V2
Cornblath, DR1
Corse, A1
Freimer, M1
Simmons-O'Brien, E1
Vogelsang, G1
Apfel, SC1
Zochodne, DW1
Zara, G2
Rondinone, R1
Della Libera, S1
Ruggero, S1
Ghirardello, A1
Zampieri, S1
Doria, A1
Cavaletti, G1
Beronio, A1
Reni, L1
Ghiglione, E1
Schenone, A1
Cocito, D1
Isoardo, G1
Ciaramitaro, P1
Plasmati, R2
Pastorelli, F2
Frigo, M1
Piatti, M1
Carpo, M1
Arné-Bès, MC1
Tosi, P1
Zamagni, E1
Cellini, C1
Cangini, D1
Tacchetti, P1
Perrone, G1
Tura, S1
Baccarani, M1
Cavo, M1
Umapathi, T1

Clinical Trials (5)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Multicenter, Interventional, Single-arm, Phase IV Study Evaluating Tolerability of Eribulin and Its Relationship With a Set of Polymorphisms in an Unselected Population of Female Patients With Metastatic Breast Cancer[NCT02864030]Phase 4200 participants (Actual)Interventional2014-05-31Completed
Relevance of Monitoring Blood Levels Compared to Salivar Levels of Drugs Used in Rheumatic Autoimmune Diseases: Adherence and Understanding the Possible Underlying Mechanisms Involved in Effectiveness and in Adverse Effects[NCT03122431]Phase 493 participants (Actual)Interventional2017-06-05Completed
Phase I / II Study Of Carfilzomib (CFZ) Intensification Early After Autologous Transplantation (AHCT) For Plasma Cell Myeloma[NCT01658904]Phase 1/Phase 23 participants (Actual)Interventional2012-07-31Terminated (stopped due to study closed prematurely because investigator left National Institutes of Health)
Rapamycin-Resistant T Cell Therapy of Multiple Myeloma: Relapse Prevention and Relapse Therapy[NCT01239368]Phase 1/Phase 234 participants (Actual)Interventional2010-11-10Terminated (stopped due to Terminated due to insufficient accrual.)
Mobilization and Collection of Autologous Stem Cell for Transplantation (ASCT) for Plasma Cell Myeloma (PCM)[NCT01547806]Phase 249 participants (Actual)Interventional2012-02-22Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Serum Levels of Hydroxycloroquine

Serum levels of hydroxycloroquine by LCMS (NCT03122431)
Timeframe: 12 months

Interventionng/mL (Mean)
Inactive SLE With Standard Dose of HCQ991.6
Inactive SLE With Reduced Dose of HCQ569.0

Serum Levels of Thalidomide

Serum levels of thalidomide by liquid chromatography and tandem mass spectrometry (HPLC-MS/MS) (NCT03122431)
Timeframe: 12 months

Interventionng/mL (Mean)
SLE/Cutaneous Lupus With Thalidomide415.1

Engraftment Failure Transplant Related Mortality

Engraftment failure is defined as the failure to achieve neutrophil engraftment by day 21; defined from day 0, day of autologous hematopoietic cell transplantation (AHCT), as the first of three consecutive days on which the patient's absolute neutrophil count is greater than 0.5x10(9)/l following the nadir. Transplant related mortality is defined as any subject who dies in the first 100 days post-AHCT of any non-relapse related cause. (NCT01658904)
Timeframe: up to day 100

Interventionparticipants (Number)
Cohort 1- CFZ 20 mg/m^2 (Day 1,2)0

Number of Participants With Adverse Events

Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module. (NCT01658904)
Timeframe: 8 months and 15 days

Interventionparticipants (Number)
Cohort 1- CFZ 20 mg/m^2 (Day 1,2)1

Count of Participants With Serious and Non-serious Adverse Events Assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0)

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01239368)
Timeframe: Date treatment consent signed to last date off study, 81 months and 6 days

InterventionParticipants (Count of Participants)
Cohort 1 - 1x10(5) T Cells/kg1
Cohort 2 - 5x10(5) T Cells/kg1
Cohort 3 - 1x10(6) T Cells/kg1
Cohort 4 - 3x10(6) T Cells/kg2
Cohort 5 - 5x10(6) T Cells/kg5
Cohort 5B - 5x10(6) T Cells/kg2
Cohort 6 - 15x10(6) T Cells/kg3
Cohort 7 - 45x10(6) T Cells/kg0
Cohort A - Th1/Tc1.Rapa Prevention of Relapse1
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma4

Number of Participants With Progression Free Survival in Cohort A Th1 (Type 1 T Helper Cells)/Tc1 (T Cytotoxic Cells, Type 1) Rapa Prevention of Relapse

Progressive disease is assessed by the Consensus of the International Myeloma Working Group criteria and is defined as one or more of the following: Increases of greater or equal to 25% in serum M-component (minimum absolute increase of 0.5 g/dl) or urine M-component (minimum absolute increase of 200mg/24h) or percentage of bone marrow plasma cells (minimum absolute percentage of 10%) or size of bone lesions or new plasmacytoma, or development of hypercalcemia solely attributable to the disease. (NCT01239368)
Timeframe: Study completion at 22 months

InterventionParticipants (Count of Participants)
Cohort A - Th1/Tc1.Rapa Prevention of Relapse1

Number of Patients Who Developed a Partial Response (PR)+Complete Response (CR) in Cohort B at Any Time Point Post Therapy With PR/CR Being Maintained Until Study Completed

Patients whose tumors shrunk and were disease free after therapy in cohort B. Partial response and complete response were assessed by the Consensus of the International Myeloma Working Group criteria. Partial response is defined as 50% or greater reduction in serum M-protein and 90% or greater reduction in 24-h urinary M-protein (or to less than 200 mg per 24h), 50% or greater reduction in the size of soft tissue plasmacytomas, if present at baseline, no evidence of progressive or new bone lesions if radiographic studies were performed (X-rays not required in absence of clinical indication). Complete response is defined as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and 5% or less plasma cells in bone marrow and no evidence of progressive or new bone lesion if radiographic studies were performed. Progressive disease is increases of ≥25% in serum M-component/urine M-component, or size of bone lesions. (NCT01239368)
Timeframe: Study completion at 22 months

InterventionParticipants (Count of Participants)
Cohort B - Th1/Tc1.Rapa for Relapsed Multiple Myeloma2

Number of Patients With an Adverse Event Attributable to the Investigational Therapy

Participants were assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0) (NCT01239368)
Timeframe: 2 months

InterventionParticipants (Count of Participants)
Cohort 1 - 1x10(5) T Cells/kg0
Cohort 2 - 5x10(5) T Cells/kg0
Cohort 3 - 1x10(6) T Cells/kg0
Cohort 4 - 3x10(6) T Cells/kg0
Cohort 5 - 5x10(6) T Cells/kg0
Cohort 5B - - 5x10(6) T Cells/kg0
Cohort 6 - 15x10(6) T Cells/kg0
Cohort 7- 45x10(6) T Cells/kg0
Cohort A - Th1/Tc1.Rapa Prevention of Relapse0
Cohort B - Th1/Tc1.Rapa Prevention of Relapse0

Average Number of Cluster of Differentiation 34 (CD34) Cells Collected (Per kg Recipient Body Weight (BW))

Progenitor cells by apheresis was determined by flow cytometry. (NCT01547806)
Timeframe: Through Day 2 of collection

InterventionNumber of CD34 cells per kg/BW (x 10EE6) (Mean)
Hematopoietic Progenitor Cells6.4

Median and Standard Deviation of Cluster of Differentiation 34 (CD34) Cells Collected (Per Kg Recipient Body Weight) (BW)

Progenitor cells by apheresis was determined by flow cytometry. (NCT01547806)
Timeframe: Through Day 2 of collection

InterventionNumber of CD34 cells per kg/BW (x 10EE6) (Median)
Hematopoietic Progenitor Cells6.3

Number of Hematopoietic Progenitor Cell (HPC) Apheresis Products Collected and Cryopreserved for Subsequent Use in Autologous Hematopoietic Cell Transplantation (AHCT) in Subjects With Plasma Cell Myeloma (PCM)

The cryopreserved stem cells are stored under Good Manufacturing Practice (GMP) conditions in the National Institutes of Health (NIH) Department of Transfusion Medicine until a referring physician requests the products for standard clinical care. (NCT01547806)
Timeframe: Indefinitely until a referring physician requests the product for standard clinical care or until product(s) is no longer needed and disposed of

Interventionproducts (Number)
Hematopoietic Progenitor Cells (HPC)49

Number of Participants With Serious and Non-Serious Adverse Events

Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. (NCT01547806)
Timeframe: 27 months and 27 days

InterventionParticipants (Count of Participants)
Hematopoietic Progenitor Cells (HPC)16

Percentage of Patients Achieving at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight on Day 1 of Apheresis

Progenitor cells by apheresis was determined by flow cytometry. The stated goal was a minimum dose of 2x10EE^6/kg following apheresis. (NCT01547806)
Timeframe: Day 1 of apheresis

Interventionpercentage of patients (Number)
Hematopoietic Progenitor Cells (HPC)98

Percentage of Patients Requiring 2 Days to Achieve at Least 2 x 10^6 Cluster of Differentiation 34 (CD34) Cells Per Kg Recipient Body Weight

Progenitor cells by apheresis was determined by flow cytometry. (NCT01547806)
Timeframe: Through Day 2 of collection

Interventionpercentage of patients (Number)
Hematopoietic Progenitor Cells2

Percentage of Patients That Achieved ≥ 2 x 10^6 But Less Than 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg (Day One Collection)

Percentage of patents achieving collecting the minimum but not optimal CD34 cell number. (NCT01547806)
Timeframe: Day one of collection

Interventionpercentage of patients (Number)
Hematopoietic Progenitor Cells31

Range of Cluster of Differentiation 34 (CD34) Cells Collected

Progenitor cells by apheresis was determined by flow cytometry. (NCT01547806)
Timeframe: Through Day 2 of collection

InterventionNumber of CD34 cells per kg/BW (x 10EE6) (Median)
Hematopoietic Progenitor Cells6.3

25th and 75th Percentile Values of Cluster of Differentiation 34 (CD34) Cells Collected

Progenitor cells by apheresis was determined by flow cytometry. (NCT01547806)
Timeframe: Through Day 2 of collection

InterventionNumber of CD34 cells per kg/BW (x 10EE6) (Number)
25th percentile75th percentile
Hematopoietic Progenitor Cells4.08.0

Percentage of Patients That Achieved or Did Not Achieve 5 x 10^6 Cluster of Differentiation 34 (CD34) Cells/kg

Here is the percentage of patients that achieved or did not achieve 5 x 10^6 CD34 cells/kg in a single apheresis. (NCT01547806)
Timeframe: Through Day 2 of collection

Interventionpercentage of patients (Number)
Achieved 5 x 10EE CD34 cells/kgDid not achieve 5 x 10EE CD34 cells/kg
Hematopoietic Progenitor Cells6535

Percentage of Patients That Required Plerixafor + Granulocyte-colony Stimulating Factor (G-CSF) And Only G-CSF (no Plerixafor)

Percentage of patients that required Plerixafor injection in addition to G-CSF mobilization or none at all (NCT01547806)
Timeframe: One week of mobilization therapy

Interventionpercentage of patients (Number)
Plerixafor + G-CSFOnly G-CSF (no plerixafor)
Hematopoietic Progenitor Cells4753

Reviews

3 reviews available for thalidomide and Encephalopathy, Toxic

ArticleYear
Vinca alkaloids, thalidomide and eribulin-induced peripheral neurotoxicity: From pathogenesis to treatment.
    Journal of the peripheral nervous system : JPNS, 2019, Volume: 24 Suppl 2

    Topics: Antineoplastic Agents; Cohort Studies; Furans; Humans; Immunosuppressive Agents; Ketones; Neoplasms;

2019
[Neurotoxic effects of medications: an update].
    Revue medicale de Liege, 2004, Volume: 59 Suppl 1

    Topics: Anti-Retroviral Agents; Antineoplastic Agents; Carboplatin; Cisplatin; Colchicine; Docetaxel; Humans

2004
Toxic neuropathy.
    Current opinion in neurology, 2005, Volume: 18, Issue:5

    Topics: Animals; Boronic Acids; Bortezomib; Clinical Trials as Topic; Epothilones; Genetic Therapy; Humans;

2005

Trials

2 trials available for thalidomide and Encephalopathy, Toxic

ArticleYear
Thalidomide-induced neuropathy.
    Neurology, 2002, Dec-24, Volume: 59, Issue:12

    Topics: Adult; Bone Marrow Transplantation; Female; Graft vs Host Disease; Humans; Immunosuppressive Agents;

2002
Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma.
    European journal of haematology, 2005, Volume: 74, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Dose-Response Relationsh

2005
Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma.
    European journal of haematology, 2005, Volume: 74, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Dose-Response Relationsh

2005
Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma.
    European journal of haematology, 2005, Volume: 74, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Dose-Response Relationsh

2005
Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma.
    European journal of haematology, 2005, Volume: 74, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Dose-Response Relationsh

2005
Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma.
    European journal of haematology, 2005, Volume: 74, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Dose-Response Relationsh

2005
Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma.
    European journal of haematology, 2005, Volume: 74, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Dose-Response Relationsh

2005
Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma.
    European journal of haematology, 2005, Volume: 74, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Dose-Response Relationsh

2005
Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma.
    European journal of haematology, 2005, Volume: 74, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Dose-Response Relationsh

2005
Neurological toxicity of long-term (>1 yr) thalidomide therapy in patients with multiple myeloma.
    European journal of haematology, 2005, Volume: 74, Issue:3

    Topics: Adult; Aged; Antineoplastic Combined Chemotherapy Protocols; Dexamethasone; Dose-Response Relationsh

2005

Other Studies

7 other studies available for thalidomide and Encephalopathy, Toxic

ArticleYear
CPS49-induced neurotoxicity does not cause limb patterning anomalies in developing chicken embryos.
    Journal of anatomy, 2018, Volume: 232, Issue:4

    Topics: Angiogenesis Inhibitors; Animals; Body Patterning; Bungarotoxins; Chick Embryo; Embryonic Developmen

2018
Lenalidomide long-term neurotoxicity: Clinical and neurophysiologic prospective study.
    Neurology, 2016, Sep-13, Volume: 87, Issue:11

    Topics: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors; Dose-Response Relationship, Drug; Drug Resi

2016
Genetic factors underlying the risk of thalidomide-related neuropathy in patients with multiple myeloma.
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2011, Mar-01, Volume: 29, Issue:7

    Topics: Aged; Antineoplastic Combined Chemotherapy Protocols; Dose-Response Relationship, Drug; Female; Gene

2011
Thalidomide and lenalidomide: overview of the French pharmacovigilance database.
    Prescrire international, 2012, Volume: 21, Issue:125

    Topics: Databases, Factual; France; Hematologic Diseases; Humans; Immunosuppressive Agents; Lenalidomide; Mu

2012
Thalidomide neuropathy: too much or too long?
    Neurology, 2004, Jun-22, Volume: 62, Issue:12

    Topics: Humans; Immunosuppressive Agents; Neurotoxicity Syndromes; Peripheral Nervous System Diseases; Thali

2004
Thalidomide neurotoxicity: prospective study in patients with lupus erythematosus.
    Neurology, 2004, Jun-22, Volume: 62, Issue:12

    Topics: Adult; Electrophysiology; Humans; Immunosuppressive Agents; Lupus Erythematosus, Cutaneous; Middle A

2004
Thalidomide sensory neurotoxicity: a clinical and neurophysiologic study.
    Neurology, 2004, Jun-22, Volume: 62, Issue:12

    Topics: Adult; Aged; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Neurotoxicity Synd

2004