![]() ![]() Median progression-free survival was 33.6 months (95% CI = 27.2–37.4 months) in the VTd plus observation group, and not reached in the D-VTd plus daratumumab, D-VTd plus observation, or VTd plus daratumumab groups (95% CI = not evaluable–not evaluable for all). 0001).Ī prespecified analysis showed a significant interaction between maintenance and induction and consolidation therapy ( P <. The preplanned interim analysis is considered the primary analysis of progression-free survival based on recommendation of the independent data monitoring committee.Īt a median follow-up of 35.4 months (interquartile range = 30.2–39.9 months) from second random assignment, median progression-free survival was not reached (95% confidence interval = not evaluable–not evaluable) in the daratumumab group vs 46.7 months (95% CI = 40.0 months–not evaluable) in the observation group (hazard ratio = 0.53, 95% CI = 0.42–0.68, P <. The part 2 primary endpoint was progression-free survival from second random assignment. Daratumumab maintenance was given at 16 mg/kg every 8 weeks for up to 2 years. ![]() In part 2, 886 patients still on study postconsolidation (day 100 post-ASCT) who had experienced partial response or better (458 of the D-VTd group 428 of the VTd group) were randomly assigned between May 2016 and June 2018 to receive daratumumab maintenance (n = 442 229 from the D-VTd group, 213 from the VTd group) or observation only (n = 444 229 from the D-VTd group, 215 from the VTd group). As previously reported, D-VTd was associated with improved depth of response and significantly better progression-free survival. In part 1 of the European multicenter open-label trial, 1,085 patients aged ≤ 65 years were randomly assigned to receive daratumumab, bortezomib, thalidomide, and dexamethasone (D-VTd n = 543) or bortezomib, thalidomide, and dexamethasone (VTd n = 542) as induction and posttransplantation consolidation.
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