Patients with newly diagnosed multiple myeloma (NDMM) ineligible for transplant may have an improved progression-free survival (PFS) if treated with daratumumab (D) plus bortezomib, melphalan, and prednisone (VMP) compared with VMP alone, according to a late breaking abstract being presented at the 2017 American Society of Hematology (ASH) Annual Meeting in Atlanta, Georgia.1
A previous study demonstrated that patients with relapsed MM have a superior PFS and greater depth of response when treated with D-VMP.
For the phase 3 ALCYONE study (ClinicalTrials.gov Identifier: NCT02195479), researchers randomly assigned 706 patients with NDMM ineligible for transplant or chemotherapy to receive VMP with or without D. Patients were stratified by age (median, 71 years) and International Staging System (19.3%, 42.4%, and 38.4% of patients had stage I, II, and III disease, respectively); 46.3% of patients were male. Nearly 16% of patients were high risk by cytogenetic analysis.
After a median follow-up of 16.5 months, the risk of progression or death was 50% lower among patients treated with D-VMP compared with VMP (P < .0001). Median PFS was not evaluable in the D-VMP arm compared with 18.1 months in the VMP arm.
PFS benefit from D-VMP was observed across all subgroups regardless of age, stage, and risk status.
The most frequent treatment-related adverse events (AEs) included neutropenia, thrombocytopenia, anemia, peripheral sensory neuropathy, upper respiratory tract infection, diarrhea, pyrexia, and nausea.
The authors concluded that “[t]hree phase 3 studies have now demonstrated a consistent doubling of PFS and more than threefold increase in MRD-negativity rate when combining D with [standard of care] regimens. These results support the use of a D-based combination, D-VMP, in transplant ineligible NDMM.”
- Mateos MV, Dimopoulos MA, Cavo M, et al. Phase 3 randomized study of daratumumab plus bortezomib, melphalan, and prednisone (D-VMP) versus bortezomib, melphalan, and prednisone (VMP) in newly diagnosed multiple myeloma (NDMM) patients (pts) ineligible for transplant (ALCYONE). Oral presentation at: American Society of Hematology 59th Annual Meeting & Exposition; December 9-12, 2017; Atlanta, GA.
This article originally appeared on Cancer Therapy Advisor