The addition of daratumumab to a conventional regimen is associated with a 2-fold increase in progression-free survival (PFS) in patients with newly diagnosed multiple myeloma who are ineligible for transplant, according to a recent study.
Findings from the study will be presented on Tuesday, December 12, 2017, at the American Society of Hematology (ASH) 59th Annual Meeting & Exposition (Atlanta, GA).
In the ALCYONE study, Maria-Victoria Mateos, University of Salamanca (Spain), and colleagues assessed 706 patients aged 65 years or older or otherwise not eligible to receive high-dose chemotherapy with autologous stem cell transplantation. Patients were randomly assigned to receive either D-VMP (n = 350) or VMP (n = 356) and were categorized in accordance with the International Staging System and age (younger than 75 years vs 75 years or older). Follow-up lasted a median of 16.5 months.
The primary endpoint was PFS, and secondary endpoints included overall response rate, rate of very good partial response (VGPR) or better, rate of complete response, minimal residual disease (MRD)-negativity rate, overall survival (OS), and safety.
Results of the study showed that patients with D-VMP had a 50% lower risk of disease progression or mortality vs those treated with VMP alone (HR, 0.50). The researchers noted that, compared with 18.1 months, median PFS had not been reached at 16.1 months for D-VMP compared with VMP. The PFS treatment benefit of D-VMP vs VMP was observed consistently across all subgroups.
The most commonly reported all-grade treatment emergent adverse events included neutropenia, thrombocytopenia, anemia, peripheral sensory neuropathy, upper respiratory tract infection, diarrhea, pyrexia, and nausea. A total of 23.1% of patients on D-VMP developed grade 3/4 infections compared with 14.7% of patients on VMP. Approximately 2.3% of patients on D-VMP and 2.5% of patients on VMP developed secondary primary malignancy.
“The combination of D with VMP in transplant ineligible newly diagnosed multiple myeloma patients doubled the PFS (HR, 0.50), which was driven by more patients achieving deep responses, including significantly higher complete response rate and tripling of the MRD-negativity rate,” the researchers concluded. “No new safety signals were observed when combining D with VMP. These results support the use of a D-based combination, D-VMP, in transplant ineligible newly diagnosed multiple myeloma.”—Christina Vogt