glycine has been researched along with Exanthem in 5 studies
Excerpt | Relevance | Reference |
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"In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 722 patients who had relapsed, refractory, or relapsed and refractory multiple myeloma to receive ixazomib plus lenalidomide-dexamethasone (ixazomib group) or placebo plus lenalidomide-dexamethasone (placebo group)." | 9.22 | Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. ( Bahlis, NJ; Baker, BW; Berg, DT; Buadi, FK; Cavo, M; Di Bacco, A; Ganly, P; Garderet, L; Gimsing, P; Grzasko, N; Hansson, M; Hui, AM; Jackson, SR; Kumar, S; Laubach, JP; Lin, J; Masszi, T; Moreau, P; Palumbo, A; Pour, L; Richardson, PG; Sandhu, I; Simpson, DR; Stoppa, AM; Touzeau, C; van de Velde, H, 2016) |
"Ixazomib is an oral proteasome inhibitor approved in combination with lenalidomide and dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM)." | 8.12 | Population pharmacokinetic/pharmacodynamic joint modeling of ixazomib efficacy and safety using data from the pivotal phase III TOURMALINE-MM1 study in multiple myeloma patients. ( Diderichsen, PM; Gupta, N; Hanley, MJ; Labotka, R; Srimani, JK; Venkatakrishnan, K, 2022) |
"In this double-blind, placebo-controlled, phase 3 trial, we randomly assigned 722 patients who had relapsed, refractory, or relapsed and refractory multiple myeloma to receive ixazomib plus lenalidomide-dexamethasone (ixazomib group) or placebo plus lenalidomide-dexamethasone (placebo group)." | 5.22 | Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. ( Bahlis, NJ; Baker, BW; Berg, DT; Buadi, FK; Cavo, M; Di Bacco, A; Ganly, P; Garderet, L; Gimsing, P; Grzasko, N; Hansson, M; Hui, AM; Jackson, SR; Kumar, S; Laubach, JP; Lin, J; Masszi, T; Moreau, P; Palumbo, A; Pour, L; Richardson, PG; Sandhu, I; Simpson, DR; Stoppa, AM; Touzeau, C; van de Velde, H, 2016) |
"Ixazomib is an oral proteasome inhibitor approved in combination with lenalidomide and dexamethasone for the treatment of relapsed/refractory multiple myeloma (MM)." | 4.12 | Population pharmacokinetic/pharmacodynamic joint modeling of ixazomib efficacy and safety using data from the pivotal phase III TOURMALINE-MM1 study in multiple myeloma patients. ( Diderichsen, PM; Gupta, N; Hanley, MJ; Labotka, R; Srimani, JK; Venkatakrishnan, K, 2022) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 1 (20.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 1 (20.00) | 29.6817 |
2010's | 2 (40.00) | 24.3611 |
2020's | 1 (20.00) | 2.80 |
Authors | Studies |
---|---|
Srimani, JK | 1 |
Diderichsen, PM | 1 |
Hanley, MJ | 1 |
Venkatakrishnan, K | 1 |
Labotka, R | 1 |
Gupta, N | 2 |
Richardson, PG | 2 |
Baz, R | 1 |
Wang, M | 1 |
Jakubowiak, AJ | 1 |
Laubach, JP | 2 |
Harvey, RD | 1 |
Talpaz, M | 1 |
Berg, D | 1 |
Liu, G | 1 |
Yu, J | 1 |
Di Bacco, A | 2 |
Hui, AM | 2 |
Lonial, S | 1 |
Moreau, P | 1 |
Masszi, T | 1 |
Grzasko, N | 1 |
Bahlis, NJ | 1 |
Hansson, M | 1 |
Pour, L | 1 |
Sandhu, I | 1 |
Ganly, P | 1 |
Baker, BW | 1 |
Jackson, SR | 1 |
Stoppa, AM | 1 |
Simpson, DR | 1 |
Gimsing, P | 1 |
Palumbo, A | 1 |
Garderet, L | 1 |
Cavo, M | 1 |
Kumar, S | 1 |
Touzeau, C | 1 |
Buadi, FK | 1 |
Berg, DT | 1 |
Lin, J | 1 |
van de Velde, H | 1 |
Heras-Mendaza, F | 1 |
Casado-Fariñas, I | 1 |
Paredes-Gascón, M | 1 |
Conde-Salazar, L | 1 |
Dudgeon, JA | 1 |
Marshall, WC | 1 |
Peckham, CS | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
An Open-Label, Dose-Escalation, Phase 1 Study of the Oral Form of Ixazomib (MLN9708), a Second-Generation Proteasome Inhibitor, in Adult Patients With Relapsed and/or Refractory Multiple Myeloma[NCT00932698] | Phase 1 | 60 participants (Actual) | Interventional | 2009-10-12 | Completed | ||
A Phase I/II Study of Carfilzomib, Iberdomide (CC-220) and Dexamethasone (KID) in Patients With Newly Diagnosed Transplant Eligible Multiple Myeloma[NCT05199311] | Phase 1/Phase 2 | 66 participants (Anticipated) | Interventional | 2022-05-13 | Recruiting | ||
GEM21menos65. A Phase III Trial for NDMM Patients Who Are Candidates for ASCT Comparing Extended VRD Plus Early Rescue Intervention vs Isatuximab-VRD vs Isatuximab-V-Iberdomide-D[NCT05558319] | Phase 3 | 480 participants (Anticipated) | Interventional | 2022-10-31 | Not yet recruiting | ||
A Phase 3, Randomized, Double-Blind, Multicenter Study Comparing Oral Ixazomib (MLN9708) Plus Lenalidomide and Dexamethasone Versus Placebo Plus Lenalidomide and Dexamethasone in Adult Patients With Relapsed and/or Refractory Multiple Myeloma[NCT01564537] | Phase 3 | 722 participants (Actual) | Interventional | 2012-08-01 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
MTD was highest dose of Ixazomib, at which <=1 of 6 participants experienced dose-limiting toxicity (DLT) during Cycle 1 of Phase 1. DLT was defined as any of following considered possibly related to therapy: Grade 4 neutropenia (absolute neutrophil count [ANC] <500 cell per cubic millimeter [cells/mm^3]) for >7 days;Grade 3 neutropenia with fever or infection; Grade 4 thrombocytopenia (platelets < 25,000/mm^3) for >7 days;Grade 3 thrombocytopenia with clinically significant bleeding; platelet count <10,000/mm^3; Grade 2 peripheral neuropathy with pain or >=Grade 3 peripheral neuropathy; >=Grade 3 nausea/emesis, diarrhea controlled by supportive therapy; Grade 3 QTc prolongation (QTc >500 millisecond [msec]);any >=Grade 3 nonhematologic toxicity except Grade 3 arthralgia/myalgia; or <1 week Grade 3 fatigue; delay in initiation of the subsequent therapy cycle by >2 weeks; other >=Grade 2 study drug-related nonhematologic toxicities requiring therapy discontinuation. (NCT00932698)
Timeframe: Cycle 1 (21 days)
Intervention | mg/m^2 (Number) |
---|---|
Ixazomib (All Groups) | 2 |
The number of participants with any clinically significant changes in vital signs collected throughout the study that were reported as TEAEs. Measurement of vital signs, included oral temperature, blood pressure, and heart rate. (NCT00932698)
Timeframe: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Intervention | Participants (Count of Participants) |
---|---|
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 0 |
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 0 |
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 0 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 0 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 0 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 0 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 1 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 0 |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 |
The RP2D of Ixazomib was determined in Part 1 (dose escalation) on the basis of the totality of safety, tolerability, pharmacokinetics (PK) and pharmacodynamic data observed in Cycle 1 and beyond. (NCT00932698)
Timeframe: Cycle 1 through Cycle 39 (Up to 28.3 months)
Intervention | mg/m^2 (Number) |
---|---|
Ixazomib (All Groups) | 2 |
(NCT00932698)
Timeframe: Cycle 1, Day 11: predose and at multiple time points (up to 264 hours) postdose
Intervention | hr (Mean) |
---|---|
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 135.00 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 126.50 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 129.33 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 105.88 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 92.70 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 115.85 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 123.06 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 124.93 |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 134.00 |
(NCT00932698)
Timeframe: Cycle 1, Day 11: predose and at multiple time points (Up to 264 hours) postdose
Intervention | 1/hr (Mean) |
---|---|
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 0.005 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 0.005 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 0.006 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 0.007 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 0.008 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0.006 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0.006 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 0.006 |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0.005 |
(NCT00932698)
Timeframe: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 72 hours) postdose
Intervention | hr*ng/mL (Mean) |
---|---|
Day 11 | |
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 56.53 |
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 177.67 |
(NCT00932698)
Timeframe: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 72 hours) postdose
Intervention | hr*ng/mL (Mean) | |
---|---|---|
Day 1 | Day 11 | |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 509.00 | 1010.00 |
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 109.00 | 458.00 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 159.05 | 605.00 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 251.00 | 808.50 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 449.00 | 1435.60 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 416.50 | 1915.00 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 410.00 | 2297.20 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 451.64 | 903.85 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 351.00 | 937.86 |
(NCT00932698)
Timeframe: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
Intervention | hr*ng/mL (Mean) | |
---|---|---|
Day 1 | Day 11 | |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 509.000 | 1010.000 |
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 3.383 | 56.533 |
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 20.700 | 177.667 |
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 109.000 | 458.000 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 159.050 | 605.000 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 251.000 | 808.500 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 449.000 | 1435.600 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 416.500 | 1915.000 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 410.000 | 2297.200 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 418.175 | 903.846 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 351.000 | 937.857 |
(NCT00932698)
Timeframe: Cycle 1, Days 1 and 11: Predose and at multiple time points (up to 264 hours) postdose
Intervention | ng/mL (Mean) | |
---|---|---|
Day 1 | Day 11 | |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 26.600 | 27.200 |
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 2.120 | 2.837 |
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 10.190 | 8.857 |
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 22.200 | 31.650 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 29.000 | 56.500 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 21.100 | 101.100 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 68.167 | 85.420 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 117.933 | 105.450 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 85.600 | 109.660 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 58.900 | 59.871 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 59.343 | 61.800 |
Neurotoxicity was assessed as the number of participants with the TEAE of peripheral neuropathy. (NCT00932698)
Timeframe: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Intervention | Participants (Count of Participants) | |
---|---|---|
Neuropathy Peripheral | Peripheral Sensory Neuropathy | |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 | 0 |
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 0 | 0 |
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 1 | 0 |
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 1 | 0 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 0 | 0 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 0 | 1 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 1 | 0 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 0 | 0 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 1 | 0 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 3 | 0 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 3 | 0 |
The number of participants with any clinically significant abnormal standard safety laboratory values collected throughout the study reported as TEAEs. Parameters assessed were hematology, serum chemistry and urinalysis. (NCT00932698)
Timeframe: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Intervention | Participants (Count of Participants) | |||||||||
---|---|---|---|---|---|---|---|---|---|---|
Blood Creatinine Increased | Blood Urea Increased | White Blood Cell Count Decreased | Neutrophil Count Decreased | Alanine Aminotransferase Increased | Liver Function Test Increased | Blood Calcium Increased | Platelet Count Decreased | Haematocrit Decreased | Haemoglobin Decreased | |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 1 | 0 | 0 | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 1 | 0 | 1 | 1 | 0 | 0 | 0 | 1 | 0 | 0 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 2 | 0 | 0 | 0 | 1 | 1 | 0 | 0 | 0 | 0 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 2 | 1 | 0 | 1 | 0 | 0 | 0 | 0 | 1 | 1 |
An AE is any untoward medical occurrence in a participant administered a medicinal investigational drug. The untoward medical occurrence does not necessarily have to have a causal relationship with treatment. An SAE is any untoward medical occurrence that results in death;is life-threatening;requires inpatient hospitalization or prolongation of present hospitalization;results in persistent or significant disability/incapacity;is a congenital anomaly/birth defect;or is a medically important event that may not be immediately life-threatening or result in death or hospitalization, but may jeopardize the participant or may require intervention to prevent one of other outcomes listed in definition above, or involves suspected transmission via a medicinal product of an infectious agent. A TEAE is defined as an AE that occurs after administration of first dose of study drug and through 30 days after last dose of study drug or until start of subsequent antineoplastic therapy. (NCT00932698)
Timeframe: From first dose of the study drug through 30 days after the last dose of study drug or start of subsequent antineoplastic therapy (Up to 81.1 months)
Intervention | Participants (Count of Participants) | |
---|---|---|
AEs | SAEs | |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 2 | 2 |
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 3 | 0 |
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 3 | 0 |
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 3 | 2 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 3 | 2 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 3 | 0 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 7 | 5 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 4 | 3 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 6 | 3 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 20 | 14 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 12 | 6 |
ORR is defined as percentage of participants with complete response (CR) or partial response (PR) or minimal response (MR) as assessed by the investigator using International Myeloma Working Group Uniform Response criteria. CR=Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow. PR=≥50% reduction of serum M-protein and reduction in 24-h urinary M-protein by ≥90% or to <200 mg /24 h. MR=25-49% reduction in the serum monoclonal paraprotein maintained for a minimum of 6 weeks; 50-89% reduction in 24-h urinary light chain excretion, which still exceeds 200 mg/24 h, maintained for a minimum of 6 weeks; for participants with non-secretory myeloma only, 25-49% reduction in plasma cells in a bone marrow aspirate and on trephine biopsy, if biopsy is performed, maintained for a minimum of 6 weeks; 25-49% reduction in the size of soft tissue plasmacytomas; no increase in the size or number of lytic bone lesions. (NCT00932698)
Timeframe: Cycle 1 through Cycle 115 (Up to 80.1 months)
Intervention | percentage of participants (Number) | |
---|---|---|
CR+PR | CR+PR+MR | |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0 | 0 |
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 0 | 0 |
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 0 | 0 |
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 0 | 0 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 33 | 33 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 0 | 0 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 0 | 0 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 50 | 50 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 33 | 33 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 5 | 10 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 9 | 18 |
(NCT00932698)
Timeframe: Cycle 1, Days 1 and 11: Predose and at multiple time points (Up to 264 hours) postdose
Intervention | hours (Median) | |
---|---|---|
Day 1 | Day 11 | |
Carfilzomib Expansion Cohort: Ixazomib 2.0 mg/m^2 | 1.000 | 1.500 |
Dose Escalation Cohort 1: Ixazomib 0.24 mg/m^2 | 1.000 | 1.100 |
Dose Escalation Cohort 2: Ixazomib 0.48 mg/m^2 | 1.000 | 1.000 |
Dose Escalation Cohort 3: Ixazomib 0.8 mg/m^2 | 0.775 | 1.275 |
Dose Escalation Cohort 4: Ixazomib 1.2 mg/m^2 | 0.775 | 0.500 |
Dose Escalation Cohort 5: Ixazomib 1.68 mg/m^2 | 1.000 | 1.000 |
Dose Escalation Cohort 6: Ixazomib 2.0 mg/m^2 | 1.000 | 0.667 |
Dose Escalation Cohort 7: Ixazomib 2.23 mg/m^2 | 1.000 | 0.832 |
Proteasome Inhibitor-Naive Expansion Cohort: Ixazomib 2 mg/m^2 | 0.525 | 1.500 |
Relapsed and Refractory Expansion Cohort: Ixazomib 2.0 mg/m^2 | 1.000 | 1.010 |
Velcade-Relapsed (VR) Expansion Cohort: Ixazomib 2.0 mg/m^2 | 0.617 | 0.583 |
DOR was measured as the time in months from the date of first documentation of a confirmed response of PR or better (CR [including sCR] + PR+ VGPR) to the date of the first documented disease progression (PD) among participants who responded to the treatment. Response was assessed by the investigator using International Myeloma Working Group (IMWG) Criteria. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 38 months
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 26.0 |
Placebo + Lenalidomide + Dexamethasone | 21.7 |
Overall survival (OS) is defined as the time from the date of randomization to the date of death. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are not included in the analysis. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. Data is only reported for high-risk participants. (NCT01564537)
Timeframe: From the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 46.9 |
Placebo + Lenalidomide + Dexamethasone | 30.9 |
ORR was defined as the percentage of participants with Complete Response (CR) including stringent complete response (sCR), very good partial response (VGPR) and Partial Response (PR) assessed by the IRC using IMWG criteria. Percentages are rounded off to single decimal. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months(approximate median follow-up 15 months)
Intervention | percentage of participants (Number) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 78.3 |
Placebo + Lenalidomide + Dexamethasone | 71.5 |
Data is reported for percentage of participants defined by polymorphism defined by polymorphisms in proteasome genes, such as polymorphism P11A in PSMB1 gene. Percentages are rounded off to single decimal. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
Intervention | percentage of participants (Number) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 80.3 |
Placebo + Lenalidomide + Dexamethasone | 75.7 |
Overall survival is defined as the time from the date of randomization to the date of death. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. (NCT01564537)
Timeframe: From date of randomization until death (up to approximately 97 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 53.6 |
Placebo + Lenalidomide + Dexamethasone | 51.6 |
Overall survival is defined as the time from the date of randomization to the date of death. The high-risk participants whose myeloma carried del(17) subgroup was defined as the cases reported as positive for del(17) by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17) by local laboratory. Participants without documentation of death at the time of the analysis were censored at the date when they were last known to be alive. Data is only reported high-risk participants with Del(17). (NCT01564537)
Timeframe: From the time of screening until disease progression and thereafter every 12 weeks until death or study termination (up to approximately 97 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 42.2 |
Placebo + Lenalidomide + Dexamethasone | 29.4 |
Response was assessed by the IRC using International Myeloma Working Group (IMWG) Criteria. CR is defined as negative immunofixation on the serum and urine and; disappearance of any soft tissue plasmacytomas and; < 5% plasma cells in bone marrow. VGPR is defined as Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level < 100 mg per 24 hours. Percentages are rounded off to single decimal. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
Intervention | percentage of participants (Number) |
---|---|
Ixazomib + Lenalidomide + Dexamethasone | 48.1 |
Placebo + Lenalidomide + Dexamethasone | 39.0 |
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first. Response was assessed by independent review committee (IRC) using IMWG response criteria. High-risk participants are defined as participants carrying cytogenic abnormalities: del(17), translocation t(4;14), or t(14;16) as reported by the central laboratory combined with those cases that lacked a central laboratory result but with known del (17), t(4;14), or t(14;16) by local laboratory. Cytogenetic abnormalities of del(13) and +1q are not included in the analysis. (NCT01564537)
Timeframe: From date of randomization until disease progression or death up to approximately 38 months (approximate median follow-up 15 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 18.7 |
Placebo + Lenalidomide + Dexamethasone | 9.3 |
Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of first documentation of disease progression (PD) or death due to any cause, whichever occurs first. Response including PD was assessed by independent review committee (IRC) using the International Myeloma Working Group (IMWG) response criteria. PD requires 1 of the following: Increase of ≥ 25% from nadir in: Serum M-component (absolute increase ≥ 0.5 g/dl); Urine M-component (absolute increase ≥ 200 mg/24 hours); In patients without measurable serum and urine M-protein levels the difference between involved and uninvolved free light chain (FLC) levels (absolute increase > 10 mg/dl); Development of new or increase in the size of existing bone lesions or soft tissue plasmacytomas; Development of hypercalcemia (corrected serum calcium > 11.5 mg/dl) attributed solely to plasma cell proliferative disease. Status evaluated every 4 weeks until disease progression (PD) was confirmed. (NCT01564537)
Timeframe: From date of randomization until disease progression or death up to approximately 27 months (approximate median follow-up 15 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 20.6 |
Placebo + Lenalidomide + Dexamethasone | 14.7 |
TTP was measured as the time in months from the first dose of study treatment to the date of the first documented progressive disease (PD) as assessed by the IRC using IMWG criteria. (NCT01564537)
Timeframe: Day 1 of each cycle (every 4 weeks) until disease progression up to approximately 27 months (approximate median follow-up 15 months)
Intervention | months (Median) |
---|---|
Ixazomib+ Lenalidomide + Dexamethasone | 22.4 |
Placebo + Lenalidomide + Dexamethasone | 17.6 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. 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, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement. Scores are linearly transformed to a 0-100 scale. High scores for the global and functional domains indicate higher quality of life or functioning. Higher scores on the symptom scales represent higher levels of symptomatology or problems. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
Intervention | score on a scale (Mean) | |||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Global Health Index: Baseline | Global Health Index: End of Treatment | Physical Functioning: Baseline | Physical Functioning: EOT | Role Functioning: Baseline | Role Functioning: EOT | Emotional Functioning: Baseline | Emotional Functioning: EOT | Cognitive Functioning: Baseline | Cognitive Functioning: EOT | Social Functioning: Baseline | Social Functioning: EOT | Fatigue: Baseline | Fatigue: EOT | Pain: Baseline | Pain: EOT | Nausea and Vomiting: Baseline | Nausea and Vomiting: EOT | Dyspnea: Baseline | Dyspnea: EOT | Insomnia: Baseline | Insomnia: EOT | Appetite Loss: Baseline | Appetite Loss: EOT | Constipation: Baseline | Constipation: EOT | Diarrhea: Baseline | Diarrhea: EOT | Financial Difficulties: Baseline | Financial Difficulties: EOT | |
Ixazomib+ Lenalidomide + Dexamethasone | 58.4 | -6.0 | 70.0 | -4.7 | 68.4 | -8.6 | 75.1 | -2.1 | 81.9 | -7.6 | 77.9 | -6.9 | 38.4 | 6.0 | 38.0 | 2.7 | 5.0 | 3.4 | 21.2 | 5.7 | 27.4 | 0.9 | 16.9 | 4.7 | 12.2 | -1.3 | 6.3 | 17.2 | 16.7 | 0.5 |
The EORTC-QLQ-C30 is a 30-question tool used to assess the overall quality of life in cancer participants. 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, where higher scores indicate better Global Health Status/QOL. Negative changes from baseline indicate deterioration in QOL or functioning and positive changes indicate improvement. Scores are linearly transformed to a 0-100 scale. High scores for the global and functional domains indicate higher quality of life or functioning. Higher scores on the symptom scales represent higher levels of symptomatology or problems. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
Intervention | score on a scale (Mean) | ||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Global Health Index: Baseline | Global Health Index: End of Treatment | Global Health Index: Last Follow-up | Physical Functioning: Baseline | Physical Functioning: EOT | Physical Functioning: Last Follow-up | Role Functioning: Baseline | Role Functioning: EOT | Role Functioning: Last Follow-up | Emotional Functioning: Baseline | Emotional Functioning: EOT | Emotional Functioning: Last Follow-up | Cognitive Functioning: Baseline | Cognitive Functioning: EOT | Cognitive Functioning: Last Follow-up | Social Functioning: Baseline | Social Functioning: EOT | Social Functioning: Last Follow-up | Fatigue: Baseline | Fatigue: EOT | Fatigue: Last Follow-up | Pain: Baseline | Pain: EOT | Pain: Last Follow-up | Nausea and Vomiting: Baseline | Nausea and Vomiting: EOT | Nausea and Vomiting: Last Follow-up | Dyspnea: Baseline | Dyspnea: EOT | Dyspnea: Last Follow-up | Insomnia: Baseline | Insomnia: EOT | Insomnia: Last Follow-up | Appetite Loss: Baseline | Appetite Loss: EOT | Appetite Loss: Last Follow-up | Constipation: Baseline | Constipation: EOT | Constipation: Last Follow-up | Diarrhea: Baseline | Diarrhea: EOT | Diarrhea: Last Follow-up | Financial Difficulties: Baseline | Financial Difficulties: EOT | Financial Difficulties: Last Follow-up | |
Placebo + Lenalidomide + Dexamethasone | 56.4 | -6.0 | 16.7 | 67.3 | -6.2 | 0.0 | 64.4 | -8.6 | -16.7 | 75.3 | -6.1 | -25.0 | 81.6 | -5.8 | -50.0 | 75.3 | -7.9 | 0.0 | 39.5 | 6.7 | 22.2 | 38.5 | 3.8 | 0.0 | 6.0 | 0.6 | 33.3 | 23.7 | 2.3 | 0.0 | 30.5 | -0.5 | 33.3 | 15.3 | 6.5 | 0.0 | 13.5 | 2.2 | 33.3 | 8.1 | 10.8 | 0.0 | 18.6 | 1.3 | -33.3 |
The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement. Scores are linearly transformed to a 0-100 scale. Higher scores on the symptom scales (e.g. Disease Symptoms, Side Effects of Treatment) represent higher levels of symptomatology or problems. High scores for Body Image and Future Perspective represent better quality of life or functioning. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
Intervention | score on a scale (Mean) | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Disease Symptoms: Baseline | Disease Symptoms: EOT | Side Effects of Treatment: Baseline | Side Effects of Treatment: EOT | Side Effects of Treatment: Last Follow-up | Body Image: Baseline | Body Image: EOT | Body Image: Last Follow-up | Future Perspective: Baseline | Future Perspective: EOT | Future Perspective: Last Follow-up | |
Placebo + Lenalidomide + Dexamethasone | 30.41 | -2.58 | 17.97 | 4.43 | 37.04 | 79.48 | -5.38 | -33.3 | 60.26 | -2.75 | -11.11 |
The EORTC-QLQ-MY-20 is a patient-completed, 20-question quality of life questionnaire that has 4 independent subscales, 2 functional subscales (body image, future perspective), and 2 symptoms scales (disease symptoms and side-effects of treatment). The participant answers questions about their health during the past week using a 4-point scale where 1=Not at All to 4=Very Much. A negative change from Baseline indicates improvement. Scores are linearly transformed to a 0-100 scale. Higher scores on the symptom scales (e.g. Disease Symptoms, Side Effects of Treatment) represent higher levels of symptomatology or problems. High scores for Body Image and Future Perspective represent better quality of life or functioning. (NCT01564537)
Timeframe: Baseline, EOT and follow-up (up to approximately 97 months)
Intervention | score on a scale (Mean) | ||||||||
---|---|---|---|---|---|---|---|---|---|
Disease Symptoms: Baseline | Disease Symptoms: EOT | Disease Symptoms: Last Follow-up | Side Effects of Treatment: Baseline | Side Effects of Treatment: EOT | Body Image: Baseline | Body Image: EOT | Future Perspective: Baseline | Future Perspective: EOT | |
Ixazomib+ Lenalidomide + Dexamethasone | 29.71 | -2.35 | 1.11 | 17.23 | 4.52 | 78.00 | -0.27 | 56.99 | 2.76 |
Eastern Cooperative Oncology Group (ECOG) performance score, laboratory values, vital sign measurements and reported adverse events (AEs) were collected and assessed to evaluate the safety of therapy throughout the study. An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; or congenital anomaly; or a medically important event. (NCT01564537)
Timeframe: From the date of signing of the informed consent form through 30 days after the last dose of study drug up to approximately 115 months
Intervention | Participants (Count of Participants) | |
---|---|---|
TEAEs | SAEs | |
Ixazomib+ Lenalidomide + Dexamethasone | 359 | 205 |
Placebo + Lenalidomide + Dexamethasone | 357 | 201 |
"Pain response was defined as 30% reduction from Baseline in Brief Pain Inventory-Short Form (BPI-SF) worst pain score over the last 24 hours without an increase in analgesic (oral morphine equivalents) use at 2 consecutive evaluations. The BPI-SF contains 15 items designed to capture the pain severity (worst, least, average, and now [current pain]), pain location, medication to relieve the pain, and the interference of pain with various daily activities including general activity, mood, walking activity, normal work, relations with other people, sleep, and enjoyment of life. The pain severity items are rated on a 0 to 10 scale where: 0=no pain and 10=pain as bad as you can imagine and averaged for a total score of 0 (best) to 10 (Worst)." (NCT01564537)
Timeframe: Baseline and end of treatment (EOT) (up to approximately 38 months)
Intervention | Participants (Count of Participants) | |
---|---|---|
Baseline | EOT | |
Ixazomib+ Lenalidomide + Dexamethasone | 345 | 145 |
Placebo + Lenalidomide + Dexamethasone | 351 | 153 |
(NCT01564537)
Timeframe: Pre-dose and post-dose at multiple timepoints up to Cycle 10 Day 1 (each cycle length = 28 days)
Intervention | μg/mL (Mean) | ||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cycle 1 Day 1, 1 Hour Post-Dose | Cycle 1 Day 1, 4 Hours Post-Dose | Cycle 1 Day 14, Pre-Dose | Cycle 2 Day 1, Pre-Dose | Cycle 2 Day 14, Pre-Dose | Cycle 3 Day 1, Pre-Dose | Cycle 4 Day 1, Pre-Dose | Cycle 5 Day 1, Pre-Dose | Cycle 6 Day 1, Pre-Dose | Cycle 7 Day 1, Pre-Dose | Cycle 8 Day 1, Pre-Dose | Cycle 9 Day 1, Pre-Dose | Cycle 10 Day 1, Pre-Dose | |
Placebo + Lenalidomide + Dexamethasone | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
(NCT01564537)
Timeframe: Pre-dose and post-dose at multiple timepoints up to Cycle 10 Day 1 (each cycle length = 28 days)
Intervention | μg/mL (Mean) | |||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Cycle 1 Day 1 | Cycle 1 Day 1, 1 Hour Post-Dose | Cycle 1 Day 1, 4 Hours Post-Dose | Cycle 1 Day 14, Pre-Dose | Cycle 2 Day 1, Pre-Dose | Cycle 2 Day 14, Pre-Dose | Cycle 3 Day 1, Pre-Dose | Cycle 4 Day 1, Pre-Dose | Cycle 5 Day 1, Pre-Dose | Cycle 6 Day 1, Pre-Dose | Cycle 7 Day 1, Pre-Dose | Cycle 8 Day 1, Pre-Dose | Cycle 9 Day 1, Pre-Dose | Cycle 10 Day 1, Pre-Dose | |
Ixazomib+ Lenalidomide + Dexamethasone | 4.79 | 36.3 | 15.6 | 6.83 | 2.4 | 7.12 | 2.48 | 2.41 | 2.42 | 2.57 | 2.71 | 2.37 | 2.51 | 2.82 |
3 trials available for glycine and Exanthem
Article | Year |
---|---|
Phase 1 study of twice-weekly ixazomib, an oral proteasome inhibitor, in relapsed/refractory multiple myeloma patients.
Topics: Administration, Oral; Aged; Aged, 80 and over; Area Under Curve; Boron Compounds; Dose-Response Rela | 2014 |
Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols | 2016 |
Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols | 2016 |
Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols | 2016 |
Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols | 2016 |
Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols | 2016 |
Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols | 2016 |
Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols | 2016 |
Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols | 2016 |
Oral Ixazomib, Lenalidomide, and Dexamethasone for Multiple Myeloma.
Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antineoplastic Combined Chemotherapy Protocols | 2016 |
Rubella vaccine trials in adults and children. Comparison of three attenuated vaccines.
Topics: Adolescent; Adult; Age Factors; Animals; Antibodies; Antibody Formation; Body Temperature; Buffers; | 1969 |
2 other studies available for glycine and Exanthem
Article | Year |
---|---|
Population pharmacokinetic/pharmacodynamic joint modeling of ixazomib efficacy and safety using data from the pivotal phase III TOURMALINE-MM1 study in multiple myeloma patients.
Topics: Boron Compounds; Clinical Trials, Phase III as Topic; Diarrhea; Exanthema; Glycine; Humans; Multiple | 2022 |
Erythema multiforme-like eruption due to an irritant contact dermatitis from a glyphosate pesticide.
Topics: Adult; Dermatitis, Allergic Contact; Dermatitis, Irritant; Diagnosis, Differential; Erythema Multifo | 2008 |