A Study to Investigate the Clinical Benefit of Isatuximab in Combination With Bortezomib, Lenalidomide and Dexamethasone in Adults With Newly Diagnosed Multiple Myeloma Not Eligible for Transplant

About the trial

Sponsor

Sanofi

Tested

Isatuximab SAR650984 (drug), Bortezomib (drug), Lenalidomide (drug), Dexamethasone (drug)

Dates

Started 2017-12-07; completion 2027-06-30

Results posted

Not yet

Primary Objective: -To demonstrate the benefit of isatuximab in combination with bortezomib, lenalidomide, and dexamethasone in the prolongation of progression free survival (PFS) as compared to bortezomib, lenalidomide, and dexamethasone, in participants with newly diagnosed multiple myeloma (NDMM) not eligible for transplant. Secondary Objectives: * To evaluate in both randomized (isatuximab, bortezomib, lenalidomide and dexamethasone combination (IVRd) and bortezomib, lenalidomide and dexamethasone combination (VRd)) arms: * Complete response (CR) rate, as defined by the International Myeloma Working Group (IMWG) criteria. * Minimal residual disease (MRD) negativity rate in participant…

From ClinicalTrials.gov, last updated 2026-05-04. Full record, eligibility and contacts (opens in a new tab)

Industry funding

Sanofi US Services Inc. reported $50,143 in research payments for this study in 2025 (7 payments).

Products named: Sarclisa

Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.