Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): A randomised, open-label, phase 3 study
The Lancet Jun 07, 2019
Moreau P, et al. - Through the two-part, randomized, open-label, phase 3 CASSIOPEIA trial, which is the first study showing the clinical benefit of daratumumab plus standard of care in transplant-eligible patients with newly diagnosed multiple myeloma, researchers assessed if in newly diagnosed multiple myeloma patients an improved stringent complete response rate could be achieved with daratumumab added to bortezomib, thalidomide, and dexamethasone (VTd) before and after autologous stem-cell transplantation. Patients were randomized 1:1 to receive four pre-transplant induction and two post-transplant consolidation cycles of VTd alone (VTd group) or in combination with daratumumab (D-VTd group). There were 1,085 patients from 111 European sites who were randomized to the D-VTd group (n=543) or the VTd group (n=542). Neutropenia, lymphopenia, and stomatitis were most common adverse events noted of grade 3 or 4. Improved response depth and progression-free survival and satisfactory safety was noted with D-VTd before and after autologous stem-cell transplantation.
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