This is a phase II, multicenter, open label, single arm study that will evaluate the safety and efficacy of Isatuximab administered intravenously at 10 mg/kg in combination with CyBorD induction treatment and Lenalidomide maintenance treatment in a 28-day long cycle in autologous stem cell transplant-eligible patients.~The induction treatment consists of four cycles of Isa-CyBorD. Isatuximab will be given on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of cycle 2-4 in combination with Cyclophosphamide at 300 mg/m2 on days 1, 8, 15 and 22, Bortezomib at 1.5 mg/m2 on days 1, 8, 15 and 22 and Dexamethasone at 40 mg on days 1, 8, 15 and 22 of each 28-day cycle.~Following the induction phase, all subjects achieving at least stable disease will have stem cell mobilization per standard institutional procedures. This is followed by high dose chemotherapy (Melphalan 200 mg/m2) and autologous stem cell transplantation.~((If, for unexpected logistical reason, there is a foreseen delay of stem cell mobilization or transplantation of more than eight weeks after the end of cycle four of induction, an additional cycle of Isa-CyBorD can be given at the investigator's discretion.))~The maintenance treatment consisting of Isatuximab at 10 mg/kg administered intravenously on days 1, 8, 15 and 22 of cycle 1, days 1 and 15 of cycle 2 and 3 and day 1 all subsequent 28-day maintenance cycles in combination with Lenalidomide administered orally at 10 mg on days 1-21 of each 28-day cycle will be administered starting at day 100 (+/- 7 days) after the transplant. Lenalidomide, if tolerated well, will be increased to 15 mg starting with cycle 3.
This is a phase II multi-center, open label, single arm study to evaluate the safety and efficacy of Isatuximab administered intravenously in combination with CyBorD induction treatment and Lenalidomide maintenance treatment in a 28-day long cycle in autologous stem cell transplant-eligible patients.