Long-term follow-up of phase 3 CASSIOPEIA trial of D-VTd versus VTd followed by daratumumab maintenance or observation in transplant-eligible NDMM

The multinational phase 3 CASSIOPEIA trial randomized transplant-eligible patients with newly diagnosed multiple myeloma (NDMM) to daratumumab, bortezomib, thalidomide, and dexamethasone (D-VTd) or VTd alone during pre-transplant induction and post-transplant consolidation, followed by re-randomization of patients with at least partial response to daratumumab maintenance or observation. At median 70.6 months (IQR 66.4-76.1) follow-up after the second randomization the median progression-free survival was not reached in the daratumumab maintenance group versus 45.8 months in the observation group (HR 0.49; p<0.0001). D-VTd followed by daratumumab maintenance versus D-VTd followed by observation resulted in median PFS not reached versus 72.1 months (HR 0.76; p=0.048); whereas VTd followed by daratumumab maintenance versus VTd followed by observation resulted in median PFS not reached versus 32.7 months (HR 0.34; p<0.0001). The authors conclude that including daratumumab in both the induction and consolidation phase and the maintenance phase led to superior PFS outcomes.