Study Comparing Continuous Versus Fixed Duration Therapy With Daratumumab, Lenalidomide, and Dexamethasone for Relapsed Multiple Myeloma

"Conditioning regimen: 16 mg/kg IV :~* Weekly (Cycles 1 and C2)~* Every two weeks (C3 to C6)~* Monthly from C7 up to 24 months in total (Arm 1)~Infusion reaction prophylaxis :~* Acetaminophen (paracetamol) 650-1000 mg IV or orally (PO) approximately 1 hour or less prior to infusion~* An antihistamine (diphenhydramine 25-50 mg IV or PO, or equivalent but avoid IV use of promethazine) approximately 1hour prior to infusion; after Cycle 6, if a subject has not developed an infusion-related reaction and is intolerant to antihistamines, modifications are acceptable as per investigator discretion~* Dexamethasone 40 mg IV (preferred) or PO, approximately 1 hour or less prior infusion.~Lenalidomide:~Conditioning regimen: 25 mg per os. From day 1 to day 21 of each cycle up to 24 months in total (Arm 1)~Dexamethasone:~Conditioning regimen: 40 mg at day 1 (preinfusion medication IV preferred), day 8, day 15 and day 22 per os of each cycle up to 24 months in total (Arm 1)"

"Conditioning regimen: 16 mg/kg IV :~* Weekly (Cycles 1 and C2)~* Every two weeks (C3 to C6)~* Monthly from C7 until disease progression (Arm 2).~Infusion reaction prophylaxis :~* Acetaminophen (paracetamol) 650-1000 mg IV or orally (PO) approximately 1 hour or less prior to infusion~* An antihistamine (diphenhydramine 25-50 mg IV or PO, or equivalent but avoid IV use of promethazine) approximately 1hour prior to infusion; after Cycle 6, if a subject has not developed an infusion-related reaction and is intolerant to antihistamines, modifications are acceptable as per investigator discretion~* Dexamethasone 40 mg IV (preferred) or PO, approximately 1 hour or less prior infusion.~Lenalidomide:~Conditioning regimen: 25 mg per os. From day 1 to day 21 of each cycle until disease progression (Arm 2).~Dexamethasone:~Conditioning regimen: 40 mg at day 1 (preinfusion medication IV preferred), day 8, day 15 and day 22 per os of each cycle until disease progression (Arm 2)."