IMROZ : A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide (Revlimid®) and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

• NCT03319667

Scientific Title

A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination With Bortezomib (Velcade®), Lenalidomide (Revlimid®) and Dexamethasone Versus Bortezomib, Lenalidomide and Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant

Commercial Sponsor

Sanofi Aventis

Summary

In this trial participants will be randomized to one of three arms. In the first experimental arm, participants will receive induction treatment (4x6 week cycles) with intravenous (IV) isatuximab + subcutaneous (SC) bortezomib + oral lenalidomide + IV or oral dexamethasone, followed by continuous treatment (4-week cycles) with IV isatuximab + oral lenalidomide + IV or oral dexamethasone. In the second comparator arm, participants will receive induction treatment (4x6-week cycles) with SC bortezomib + oral lenalidomide + IV or oral dexamethasone, followed by continuous treatment (4-week cycles) with oral lenalidomide + IV or oral dexamethasone. In the third arm, participants will receive just 4-weeks cycles with IV isatuximab + oral lenalidomide + IV or oral dexamethasone.