Lenalidomide, bortezomib, and dexamethasone (RVd) ± autologous stem cell transplantation (ASCT) and lenalidomide (R) maintenance to progression for newly diagnosed multiple myeloma (NDMM): The phase 3 DETERMINATION trial.
To explore the drug combination, lenalidomide, bortezomib and dexamethasone (RVd) alone or when combined with autologous stem cell transplantation to see what side effects it may have and how well it works for treatment of newly diagnosed multiple myeloma. Specifically, the objective of this trial is to determine if, in the era of novel drugs, high dose therapy (HDT) is still necessary in the initial management of multiple myeloma in younger patients. In this study, HDT as compared to conventional dose treatment would be considered superior if it significantly prolongs progression-free survival by at least 9 months or more, recognizing that particular subgroups may benefit more compared to others. The aim of the Phase 3 study is to report updates on primary data from the U.S. DETERMINATION trial, which used lenalidomide (R) maintenance until progression.
Dr. Paul G. Richardson (Dana-Farber Cancer Institute—Boston, MA) provides updates on the Phase 3 DETERMINATION Trial: RVd ± ASCT and R maintenance to progression for NDMM patients correlative analyses are ongoing.
RVd ± ASCT and R maintenance to progression resulted in the longest median progression-free survival (PFS) reported for each approach, and a highly significant 21.4-month gain in median PFS benefit using RVd + ASCT. No overall survival (OS) advantage has been observed to date.
Clinical trial information: NCT01208662
Doctor’s Bio:
Dr. Paul G. Richardson is the Clinical Program Leader at the Jerome Lipper Multiple Myeloma Center; Director of Clinical Research at the Jerome Lipper Multiple Myeloma Center; Institute Physician at Dana-Farber Cancer Institute; and RJ Corman Professor of Medicine at Harvard Medical School.
with support from:
Bristol Myers Squibb, Janssen, and Takeda Oncology
