Impact of baseline renal function on efficacy and safety of daratumumab plus bortezomib melphalan prednisone (VMP) in patients (Pts) with newly diagnosed multiple myeloma (NDMM …

user-5ebe28ba4c775eda72abcdf3(2018)

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摘要
e20024 Background: In the phase 3 ALCYONE study, daratumumab (D) in combination with VMP (D-VMP) prolonged progression-free survival (PFS) vs VMP alone, and exhibited favorable tolerability in pts with NDMM. We conducted a subgroup analysis of the efficacy and safety of D-VMP vs VMP according to baseline creatinine clearance (CrCl;≤ 60 mL/min [moderately impaired] and> 60 mL/min). Methods: Randomized pts were ineligible for high-dose chemotherapy with ASCT and had baseline CrCl≥ 40 mL/min. Up to nine 6-week VMP cycles (V 1.3 mg/m2 SC on Days [d] 1, 4, 8, 11, 22, 25, 29, 32 in Cycle [C] 1 and d 1, 8, 22, 29 in C 2-9; M 9 mg/m2 PO and P 60 mg/m2 PO on d 1-4 in C 1-9) with or without D (16 mg/kg IV QW for C1, Q3W for C 2-9, and Q4W for C 10+[post VMP-treatment phase] until progression) were received. Minimal residual disease (MRD) at 10–5threshold was evaluated using clonoSEQ …
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