Daratumumab Combined With Lenalidomide, Dexamethasone, Improves Overall Survival For Certain Patients With Multiple Myeloma
Daratumumab in combination with lenalidomide and dexamethasone increased overall survival (OS) and progression-free survival (PFS) for patients with newly diagnosed multiple myeloma ineligible for stem cell transplantation, according to the interim analysis of the phase 3 MAIA trial. No new safety concerns were encountered, which the investigators said support the frontline use of daratumumab plus lenalidomide and dexamethasone for patients with multiple myeloma who are ineligible for transplantation.
MAIA is an ongoing, multicenter, randomized, open-label, phase 3 trial that enrolled 737 eligible patients from 176 hospitals. Eligible patients were 18 years of age or older, had newly diagnosed multiple myeloma, had an Eastern Cooperative Oncology Group performance status score of 0–2, and were ineligible for high-dose chemotherapy with autologous stem-cell transplantation because of their age (≥65 years) or comorbidities.
Participants were randomized to receive 28-day cycles of either intravenous daratumumab plus oral lenalidomide and oral dexamethasone or lenalidomide and dexamethasone alone. The primary endpoint was PFS, with OS as the secondary endpoint. Neither the study participants nor the investigators were masked to treatment assignment.
At the time of the median follow-up of 56.2 months, median PFS was not reached in the daratumumab group, compared to 34.4 months in the control group. Median OS was not reached by either group.
The most common treatment-emergent adverse events (AEs) of grade 3 or higher were neutropenia (54% of patients in the daratumumab group vs 37% of patients in the control group), pneumonia (19% vs 11%), anemia (17% vs 22%), and lymphopenia (16% vs 11%).
Serious AEs occurred in 77% of the daratumumab group and 70% of the control group. Treatment-related deaths occurred in 4% of the daratumumab group and 3% of the control.
Daratumumab, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone alone in newly diagnosed multiple myeloma (MAIA): overall survival results from a randomised, open-label, phase 3 trial. The Lancet; October 13, 2021. Accessed November 1, 2021. https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(21)00466-6/fulltext