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
• Target enrollment: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion criteria:

Newly diagnosed patients with measurable multiple myeloma defined as at least one of the following:

• Serum M protein ≥1 g/dL (≥10 g/L).

• Urine M protein ≥200 mg/24 hours.

• Serum free light chain (sFLC) assay: involved free light chain assay ≥10 mg/dL (≥100 mg/L) and an abnormal sFLC ratio (<0.26 or >1.65).

Patients with ultra-high risk smoldering multiple myeloma fulfilling the International Myeloma Working Group criteria are eligible.

Patient is not eligible for transplant.

Patient with no immediate intent for transplant as per investigator's decision are also eligible for VRDI Part B cohort only.

Exclusion criteria:

Eastern Cooperative Oncology Group performance status >2.

Poor bone marrow reserve.

Poor organ function.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.