A Phase 3 randomized, open-label, multicenter study of isatuximab (SAR650984) in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone in patients with high-risk smoldering multiple myeloma

Plasma cell myeloma

Number of participants with treatment-emergent: adverse events (AEs) and serious adverse events - Safety Run-in Part, Plasma concentration of isatuximab during the treatment period: - Safety Run-in Part, Receptor density/receptor occupancy - Safety Run-in Part, Progression-free survival (PFS) - Randomized Phase 3 Part

Overall response rate (ORR) - Safety Run-in Part, Duration of response (DOR) - Safety Run-in Part, Minimal residual disease (MRD) negativity -Safety Run-in Part, Time to diagnostic (SLiM CRAB) progression or death - Safety Run-in Part, Time to first-line treatment for multiple myeloma (MM) - Safety Run-in Part, Number of participants with anti-drug antibodies (ADA) against isatuximab - Safety Run-in Part, PFS in participants with chromosomal abnormalities - Safety Run-In Part, Overall Survival (OS) in participants with chromosomal abnormalities - Safety Run-In Part, Minimal residual disease (MRD) negativity – Randomized Phase 3 Part, Sustained MRD negativity - Randomized Phase 3 Part, Second PFS (PFS2) - Randomized Phase 3 Part, OS - Randomized Phase 3 Part, Complete response (CR) rate - Randomized Phase 3 Part, Overall Response Rate (ORR) – Randomized Phase 3 Part, Duration of response (DOR) – Randomized Phase 3 Part, Time to diagnostic (SLiM CRAB) progression - Randomized Phase 3 Part, Time to biochemical progression - Randomized Phase 3 Part, Time to first-line treatment for MM- Randomized Phase 3 Part, PFS in participants with chromosomal abnormalities - Randomized Phase 3 Part, OS in participants with chromosomal abnormalities - Randomized Phase 3 Part, Number of participants with Treatment- emergent adverse events (AEs) and serious adverse events - Randomized Phase 3 Part, Plasma concentration of isatuximab (Ctrough)- Safety Run-in and Randomized Phase 3 Part, Concentration observed at the end of intravenous infusion.(Ceoi)- Safety Run-in Part, Number of participants with Incidence of anti- drug antibodies (ADA) against isatuximab-, European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 - Randomized Phase 3, EORTC QLQ-MY20 - Randomized Phase 3 Part, EQ-5D-5L - Randomized Phase 3 Part, Randomized Phase 3: HRUPQ - Randomized Phase 3 Part, Patient's Qualitative Assessment of Treatment Version 2 (PQAT-v2) - Randomized Phase 3 Part

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Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Lithuania, Norway, Poland, Spain