Daratumumab with lenalidomide and dexamethasone may be an efficacious treatment combination for patients with relapsed or refractory multiple myeloma, according to an interim study analysis published in The New England Journal of Medicine.1

Daratumumab, a monoclonal antibody that targets CD38, is approved by the U.S. Food Drug Administration for heavily pretreated patients. For this randomized, phase 3 trial (ClinicalTrials.gov Identifier: NCT02076009), researchers evaluated whether adding daratumumab to lenalidomide and dexamethasone is more efficacious than the latter 2 drugs alone.

Of 569 enrolled patients, 286 were randomized to receive the daratumumab combination, and 283 were randomized to receive lenalidomide and dexamethasone only. Median age was 65 in both groups; participants were stratified for cytogenic risk and previous treatments.

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The response rate was 92.9% in the daratumumab group and 76.4% in the control group. Among patients who responded, 121 had a complete response or better with daratumumab, while only 53 had a complete response or better in the control group. Nearly twice as many patients in the daratumumab group had a very good partial response or better in the experimental group.

Adverse events were, however, more common with daratumumab: 51.9% of patients had grade 3 or 4 neutropenia, versus only 37% of patients in the control group. Patients were also almost twice as likely to have diarrhea.

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Citing a 63% lower risk of disease progression than observed in the control group, the authors conclude that daratumumab provides clinical benefit to patients with relapsed or refractory myeloma. Follow-up analyses will indicate whether the drug combination also improves overall survival.


  1. Dimopoulos MA, Oriol A, Nahi H, et al. Daratumumab, lenalidomide, and dexamethasone for multiple myeloma. N Engl J Med 2016;375:1319-31. doi: 10.1056/NEJMoa1607751