A Phase 2 Study of Isatuximab in Combination With Bortezomib, Cyclophosphamide and Dexamethasone Followed by Isatuximab and Lenalidomide Maintenance in Newly Diagnosed Patients With Multiple Myeloma and Severe Renal Impairment

Route of administration: Intravenous (IV). Dose regimen: Isatuximab will be given at a dose of 10 mg/kg once weekly (QW) on Days 1, 8, 15, and 22 in Cycle 1, on Days 1 and 15 during Cycles 2-6 and on Day 1 from Cycle 7 onwards.

Route of administration: Subcutaneous (SC). Dose regimen: Bortezomib will be given at 1.3 mg/m2 on Days 1, 4, 8, 11 of Cycle 1 and days 1, 8, 15, 22 of Cycles 2-6.

Route of administration: Intravenous (IV). Dose regimen: Cyclophosphamide will be given at 300 mg/m2on Days 1, 8, 15 of Cycle 1 and days 1, 8, 15, 22 of Cycles 2-6.

Route of administration: per os (PO)/Intravenous (IV). Dose regimen: Dexamethasone will be given at 40 mg (20 mg for ≥75 years old) on Days 1-4 and 9-12 of Cycle 1 and Days 1, 8, 15 and 22 of Cycles 2-6.

Route of administration: per os (PO). Dose regimen: Lenalidomide will be given at 10 mg (or according to renal function) daily from Cycle 7 onwards.