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57 active trials for Plasma Cell Myeloma

Study of Isatuximab Combined With Bortezomib + Cyclophosphamide + Dexamethasone (VCD) and Bortezomib + Lenalidomide + Dexamethasone (VRD) in Newly Diagnosed Multiple Myeloma (MM) Non Eligible for Transplant or No Intent for Immediate Transplantation

Primary Objectives: VCDI cohort: To determine the maximum tolerated dose (MTD) and recommended dose (RD) of isatuximab when administered in combination with bortezomib, cyclophosphamide, and dexamethasone (VCDI) based on the dose-limiting toxicity(ies) (DLTs) observed in patients with newly diagnosed multiple myeloma non-eligible for transplantation. To evaluate safety and preliminary efficacy (overall response rate and complete response rate) of isatuximab in combination with bortezomib, dexamethasone, and cyclophosphamide in patients with newly diagnosed multiple myeloma non-eligible for transplantation. VRDI cohort parts A and B: To evaluate preliminary efficacy (complete response rate) of isatuximab in combination with bortezomib, dexamethasone, and lenalidomide in patients with newly diagnosed multiple myeloma non-eligible for transplantation or no intent for immediate transplantation. Secondary Objectives: To characterize the overall safety profile of isatuximab in combination with each bortezomib-based regimen, including cumulative toxicities. To characterize the pharmacokinetic (PK) profile of isatuximab and each combination drug in each isatuximab/bortezomib based regimen. To evaluate the immunogenicity of isatuximab in combination treatments. To evaluate the preliminary efficacy of both bortezomib based regimens in terms of duration of response, overall response rate and progression-free survival. To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density (VCDI and VRDI part only). To evaluate the infusion duration. To assess the minimal residual disease (MRD) negativity rate in patients achieving a Complete Response (CR) or Very Good Partial Response (VGPR).

Start: September 2015