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• W2891834757 abstract "8031 Background: Daratumumab (D) plus VMP (D-VMP) prolonged progression-free survival (PFS) compared with VMP and was well-tolerated in the phase 3 ALCYONE study (NCT02195479). We examined the efficacy and safety profiles of D-VMP vs VMP in elderly (≥75 y) and non-elderly ( < 75 y) NDMM pts in ALCYONE. Methods: Pts were ineligible for high-dose chemotherapy with ASCT. Pts received up to nine 6-week VMP cycles (V: 1.3 mg/m2 SC Days 1, 4, 8, 11, 22, 25, 29, 32 [Cycle 1] and Days 1, 8, 22, 29 [Cycles 2-9]; M: 9 mg/m2 PO and P: 60 mg/m2 PO Days 1-4 [Cycles 1-9]) ± D (16 mg/kg IV QW for Cycle 1, Q3W for Cycles 2-9, and Q4W for Cycles 10+ [post VMP-treatment phase] until progression). Minimal residual disease (MRD) was assessed by clonoSEQ assay (Adaptive Biotechnologies). Results: 706 (350 D-VMP; 356 VMP) pts were randomized, including 211 ≥75 y (104 D-VMP; 107 VMP) and 495 < 75 y (246 D-VMP; 249 VMP) pts. For D-VMP vs VMP, the median duration of study treatment was 14.5 mo vs 12.0 mo for ≥75 y pts and 15.0 mo vs 12.0 mo for < 75 y pts, respectively. After median follow-up of 16.5 months, PFS was prolonged with D-VMP vs VMP in both the ≥75 y (median not reached [NR] vs 20.4 mo; HR 0.53; 95% CI 0.32-0.85) and < 75 y (median NR vs 17.9 mo; HR 0.49; 95% CI 0.36-0.68) pts. ORR and ≥complete response (CR) rates were consistently higher for D-VMP vs VMP in ≥75 y (ORR: 88% vs 70%; ≥CR: 41% vs 24%) and < 75 y (ORR: 92% vs 76%; ≥CR: 43% vs 25%) pts. MRD-negative rates (10–5 threshold) also increased with D-VMP vs VMP in ≥75 y (24% vs 8%) and < 75 y (22% vs 6%) pts. Rates of most common grade 3/4 (≥10%) treatment-emergent adverse events, peripheral sensory neuropathy, and infections are in Table. D-associated infusion-related reactions were 36% (9% grade 3/4) in ≥75 y and 24% (3% grade 3/4) in < 75 y pts. Conclusions: Efficacy and safety of D-VMP vs VMP in pts ≥75 y of age were consistent with the overall study population. Clinical trial information: NCT02195479.Grade 3/4, % ≥75 y < 75 y D-VMP VMP D-VMP VMP Most common TEAEs Neutropenia 52 42 35 38 Thrombocytopenia 51 43 28 35 Anemia 24 23 13 19 Leukopenia 13 9 6 9 Lymphopenia 10 10 7 4 Pneumonia 18 9 9 2 Peripheral sensory neuropathy 0 6 2 3 Infections 28 20 21 13" @default.
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• W2891834757 date "2018-05-20" @default.
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• W2891834757 title "Daratumumab plus bortezomib-melphalan-prednisone (VMP) in elderly (≥75 y) patients (Pts) with newly diagnosed multiple myeloma (NDMM) ineligible for transplantation (ALCYONE)." @default.
• W2891834757 doi "https://doi.org/10.1200/jco.2018.36.15_suppl.8031" @default.
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