One year update of a phase 3 randomized study of daratumumab plus bortezomib, melphalan, and prednisone (D VMP) versus bortezomib, melphalan, and prednisone (VMP) in patients …

MethodsPts were≥ 65 years of age or ineligible for high-dose chemotherapy with autologous stem cell transplantation. Pts were randomized 1: 1 to receive up to nine 6-week cycles of VMP (V 1.3 mg/m 2 SC on Days 1, 4, 8, 11, 22, 25, 29, 32 [Cycle 1] and Days 1, 8, 22, and 29 [Cycles 2-9]; M 9 mg/m 2 PO and P 60 mg/m 2 PO on Days 1-4 [Cycles 1-9]) with or without DARA (16 mg/kg IV QW for Cycle 1, Q3W for Cycles 2-9, and Q4W for Cycles 10+ until disease progression). PFS was the primary endpoint. PFS on the subsequent line of therapy (PFS2), overall response rate (ORR), CR or better rate, very good partial response (VGPR) or better rate, MRD-negative rate (10-5 threshold: clonoSEQ® V2. 0, Adaptive), overall survival (OS), and safety were secondary endpoints. PFS2 was defined as the duration from randomization to progression on the next line of subsequent antimyeloma therapy or death, whichever …