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

• Status: Active, not recruiting
• Trial end date: 2026-07-01

Summary

Primary Objectives:

• VCDI cohort:

• To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR650984 isatuximab when administered in combination with bortezomib (Velcade®) , 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 administered at the selected dose in combination with bortezomib based regimin VCDI according to IMWG criteria.

• VRDI Part A cohort and Part B cohort:

• To evaluate the preliminary efficacy (complete response [CR] rate) of isatuximab administered at the selected dose in combination with bortezomib based regimen: VRDI, (bortezomib, lenalidomide, dexamethasone) according to IMWG criteria in adult patients with newly diagnosed MM non eligible for transplantation.

Secondary Objectives:

• VCDI cohort:

• To characterize the overall safety profile of SAR650984 in combination with VCD regimen, including cumulative toxicities.

• To characterize the pharmacokinetic (PK) profile of SAR650984/isatuximab and each combination drug in VCDI regimen.

• To evaluate the immunogenicity of SAR650984 in combination treatments.

• To evaluate the preliminary efficacy of VCDI regimen in terms of duration of response and progression-free survival.

• To assess the relationship between clinical effects (adverse event [AE] and/or tumor response) and CD38 receptor density.

• VRDI Part A cohort and Part B cohort:

• To characterize the overall safety profile of isatuximab in combination with VRD regimen.

• To evaluate the infusion duration (only applicable for VRDI Part B cohort)

• To characterize the PK profile of isatuximab and each combination drug in VRDI regimen.

• To evaluate the immunogenicity of isatuximab in combination treatments.

• To evaluate the preliminary efficacy of VRDI regimen in terms of ORR, DOR, and PFS.

• To evaluate the impact of M protein measurement without isatuximab interference (via the SEBIA HYDRASHIFT 2/4 isatuximab IFE test) on CR and BOR assessment.

• To assess the relationship between clinical effects (AE and/or tumor response) and CD38 receptor density (only applicable for VRDI Part A cohort).

• To assess MRD negativity rate in patients achieving a CR or VGPR and explore correlation with clinical outcome.

• Phase: Phase 1

Details

• Lead Sponsor: Sanofi
• Treatments: BB 1101; Bortezomib; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Lenalidomide