Daratumumab in combination with lenalidomide and dexamethasone induced rapid, deep, durable responses and was well-tolerated in patients relapsed/refractory multiple myeloma, a study published in Blood has shown.1

Because single-agent daratumumab has activity in relapsed/refractory multiple myeloma, researchers sought to investigate the activity and safety of the human CD38 IgG1κ monoclonal antibody plus lenalidomide and dexamethasone in a phase 1/2 study.

In part 1, 4 doses of daratumumab in that combination were evaluated in 13 patients. No dose-limiting toxicities were observed, and thus, the 16 mg/kg dose was selected as the recommended phase 2 dose.

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In phase 2, 32 patients with relapsed/refractory multiple myeloma were enrolled. The median time since diagnosis was 3.2 years and patients had a received a median of 2 prior therapies.

After a median follow-up of 15.6 months, 81% of patients had achieved a response, with 8 patients achieving stringent complete responses and 3 having complete responses; 9 patients achieved very good partial responses.

The 18-month progression-free survival and overall survival rates were 72% (95% CI, 51.7-85.0) and 90% (95% CI, 73.1-96.8), respectively.

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The most frequently reported grade 3 to 4 adverse events included neutropenia, thrombocytopenia, and anemia. Infusion-related reactions, which were mostly grade 2 or less, occurred in 56% of the 32 patients in the phase 2 portion.


  1. Plesner T, Arkenau H-T, Gimsing P, et al. Phase 1/2 study of daratumumab, lenalidomide, and dexamethasone for relapsed multiple myeloma. Blood. 2016 Aug 16. doi: 10.1182/blood-2016-07-726729. [Epub ahead of print]