Multiple Myeloma Coverage from Every Angle

EHA2021: MAIA Trial Update on Daratumumab-Based Therapy for Newly Diagnosed Myeloma

By: Julia Fiederlein
Posted: Monday, June 14, 2021

In the phase III MAIA trial, the monoclonal antibody daratumumab plus lenalidomide and dexamethasone reduced the risk of disease progression or death by 44% versus lenalidomide plus dexamethasone in patients with newly diagnosed multiple myeloma, according to Thierry Facon, MD, of the University of Lille, France, and colleagues. The 5-year follow-up of transplant-ineligible patients from the prespecified interim overall survival analysis was presented during the European Hematology Association Virtual Congress (EHA2021; Abstract LB1901).

“The favorable benefit-risk profile observed supports the use of daratumumab plus lenalidomide and dexamethasone,” the investigators commented. “These results, together with the overall survival benefit observed in [the phase III ALCYONE trial], support the use of front-line daratumumab-based combination regimens to maximize progression-free survival for optimal long-term outcomes.”

A total of 737 patients were randomly assigned in a 1:1 ratio to receive lenalidomide plus dexamethasone with or without daratumumab. Compared with lenalidomide plus dexamethasone, the addition of daratumumab reduced the risk of death by 32%; the median duration of overall survival was not reached in either treatment arm (hazard ratio = 0.68; P = .0013). The estimated 5-year overall survival rates were 66.3% and 53.1% with and without daratumumab, respectively. The updated median duration of progression-free survival was not reached with daratumumab plus lenalidomide and dexamethasone and was 34.4 months with lenalidomide plus dexamethasone (hazard ratio = 0.53; P < .0001). The estimated 5-year progression-free survival rate was higher with daratumumab than without (52.5% vs. 28.7%). The updated objective response rates were 92.9% and 81.6% with and without daratumumab, respectively (P < .0001).

The longer follow-up did not reveal any new safety signals. Neutropenia (54.1% vs. 37.0%), pneumonia (19.2% vs. 10.7%), anemia (16.8% vs. 21.6%), and lymphopenia (16.5% vs. 11.2%) were among the most commonly reported grade 3 or 4 treatment-emergent adverse events with and without daratumumab.

Disclosure: For disclosures of the study authors, visit

By continuing to browse this site you permit us and our partners to place identification cookies on your browser and agree to our use of cookies to identify you for marketing. Read our Privacy Policy to learn more.