At a glance
ClinicalIndex Comparison Record- ✓Age ≥20 years
- ✓Symptomatic multiple myeloma diagnosis
- ✓≥3 prior lines of therapy OR double refractory to IMiD and PI
- ✓Responsive (MR or better) to at least one prior line
- ✕Prior anti-CD38 agent treatment
- ✕Other malignancy within 5 years (except skin cancer, in-situ, or low-risk prostate cancer)
- ✕Grade ≥2 toxicity (except alopecia, neutropenia, neuropathy) from prior therapy
- ✕Neuropathy Grade ≥3 or painful peripheral neuropathy Grade ≥2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/II Study of Isatuximab (Anti-CD38 mAb) Administered as a Single Agent in Japanese Patients With Relapsed and Refractory Multiple Myeloma
In Brief
A Phase 2 clinical trial evaluating Isatuximab SAR650984 for Multiple Myeloma. Completed, enrolled 36 participants across 13 sites.
Detailed Summary
Primary Objectives: * Phase I: To evaluate safety and tolerability of isatuximab in Japanese participants with relapsed and refractory multiple myeloma. * Phase II: To evaluate efficacy of isatuximab at recommended dose and to further evaluate the overall response rate (ORR) of isatuximab in Japanese participants with relapsed and refractory multiple myeloma. Secondary Objectives: * To evaluate the safety including immunogenicity of isatuximab. The severity, frequency and incidence of all adverse events were assessed. * To evaluate the pharmacokinetic (PK) profile of isatuximab in the proposed dosing schedule. * To assess the efficacy using International Myeloma Working Group (IMWG) uniform response criteria. * To assess the relationship between Baseline cluster of differentiation 38 (CD38) receptor density on multiple myeloma cells and efficacy.
Study Details
Timeline
Interventions
Pharmaceutical form: solution Route of administration: intravenous