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Daratumumab and Lenalidomide/Dexamethasone in Multiple Myeloma MAIA Trial

By: Andrew Goldstein
Posted: Tuesday, September 17, 2019

The addition of daratumumab to lenalidomide/dexamethasone significantly lowered the risk of disease progression or death for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplantation when compared with lenalidomide/ dexamethasone alone, according to the MAIA phase III trial. Thierry Facon, MD, of the University of Lille, Centre Hospitalier Universitaire, France, and colleagues, published their results in The New England Journal of Medicine.

The trial included 737 patients with newly diagnosed multiple myeloma who were ineligible for autologous stem cell transplantation. Approximately half received daratumumab plus lenalidomide/dexamethasone and half received lenalidomide/dexamethasone alone.

The estimated 30-month progression-free survival for patients in the daratumumab group was 70.6%, compared with 55.6% in the control group. Complete response or better occurred in 47.6% of the daratumumab group and 24.9% of the control group. The daratumumab group also had a higher percentage of patients with results below the threshold for minimal residual disease (1 tumor cell per 105 white blood cells) than the control group (24.2% vs. 7.3%, respectively).

Additionally, the daratumumab group had a higher incidence of grade 3 or 4 adverse effects (32.1% vs. 23.3%). They included a 50% incidence of neutropenia, an 11.8% incidence of anemia, a 15.1% incidence of lymphopenia, and a 13.7% incidence of pneumonia for patients in the daratumumab group. Meanwhile, the control group had a 35.3% incidence of neutropenia, a 19.7% incidence of anemia, a 10.7% incidence of lymphopenia, and a 7.9 incidence of pneumonia.

Disclosure: The study authors’ disclosure information may be found at nejm.org.



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