![]() ![]() The supplemental Appendix includes details regarding pre- and postinfusion medications and dose modifications. Following completion of study maintenance therapy, patients can continue lenalidomide per local standard of care. Maintenance therapy on study will continue until disease progression or up to 2 years. Patients in the D-RVd group also received IV daratumumab (16 mg/kg) on day 1 every 8 weeks or every 4 weeks per protocol amendment 2 (approved 5 February 2018), based on emerging pharmacokinetic results from other studies. Starting at cycle 7, all patients received maintenance therapy (28-day cycles) consisting of oral lenalidomide (10 mg daily on days 1-21 increasing to 15 mg after 3 cycles, if tolerated). Patients in the D-RVd group received IV daratumumab (16 mg/kg) on days 1, 8, and 15 of cycles 1 through 4 and day 1 of post-ASCT consolidation cycles (cycles 5 and 6). This trial was registered at as #NCT02874742.Īll patients received four 21-day induction cycles and two 21-day consolidation cycles of oral lenalidomide (25 mg daily on days 1-14), subcutaneous bortezomib (1.3 mg/m 2 on days 1, 4, 8, and 11), and oral dexamethasone (20 mg on days 1, 2, 8, 9, 15, and 16). Daratumumab with RVd induction and consolidation improved depth of response in patients with transplant-eligible NDMM, with no new safety concerns. ![]() Median times to neutrophil and platelet engraftment were comparable. Median CD34 + cell yield was 8.2 × 10 6/kg for D-RVd and 9.4 × 10 6/kg for RVd, although plerixafor use was more common with D-RVd. More infections occurred with D-RVd, but grade 3/4 infection rates were similar. Grade 3/4 hematologic adverse events were more common with D-RVd. Four patients (3.8%) in the D-RVd group and 7 patients (6.8%) in the RVd group progressed respective 24-month progression-free survival rates were 95.8% and 89.8%. 0177), as did minimal residual disease (MRD) negativity (10 −5 threshold) rates in the intent-to-treat population (51.0% vs 20.4% P <. With longer follow-up (median, 22.1 months), responses deepened sCR rates improved for D-RVd vs RVd (62.6% vs 45.4% P =. 068) and met the prespecified 1-sided α of 0.10. The primary end point, stringent complete response (sCR) rate by the end of post-ASCT consolidation, favored D-RVd vs RVd (42.4% vs 32.0% odds ratio, 1.57 95% confidence interval, 0.87-2.82 1-sided P =. Patients (N = 207) were randomized 1:1 to D-RVd or RVd induction (4 cycles), ASCT, D-RVd or RVd consolidation (2 cycles), and lenalidomide or lenalidomide plus D maintenance (26 cycles). The addition of daratumumab (D) to RVd (D-RVd) in transplant-eligible NDMM patients was evaluated. Lenalidomide, bortezomib, and dexamethasone (RVd) followed by autologous stem cell transplantation (ASCT) is standard frontline therapy for transplant-eligible patients with newly diagnosed multiple myeloma (NDMM).
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