Trial Identifiers
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Scientific Title
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
Commercial Sponsor
Sanofi Aventis
Summary
Eligible patients will be randomised to receive intravenous Isatuximab in combination with oral lenalidomide and intravenous dexamethasone OR lenalidomide and dexamethasone alone, over a series of 28 day cycles.