Daratumumab plus lenalidomide and dexamethasone resulted in rapid, deep, durable responses in patients with refractory and relapsed/refractory multiple myeloma, according to a study published in the journal Blood.1

For the phase 1/2 study, investigators enrolled 32 patients with a median time since diagnosis of 3.2 years. Patients had received 1 to 3 prior therapies, including proteasome inhibitors (91%), alkylating agents (91%), autologous hematopoietic cell transplantation (78%), thalidomide (44%), and lenalidomide (34%).

All participants received daratumumab 16 mg/kg with lenalidomide and dexamethasone.

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Results showed that the overall response rate was 81% with 8, 3, and 9 patients achieving stringent complete responses, complete responses, and very good partial responses, respectively.

The 18-month progression-free survival rate was 72% (95% CI, 51.7-85.0) and the 18-month overall survival rate was 90% (95% CI, 73.1-96.8).

Grade 3 to 4 treatment-related adverse events in 5% of patients or more included neutropenia, thrombocytopenia, and anemia.

Daratumumab is a human CD38-directed monoclonal antibody indicated as monotherapy for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent or who are double-refractory to a proteasome inhibitor and an immunomodulatory agent.

A supplemental Biologics License Application for daratumumab, in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone, has been submitted to the US Food and Drug Administration to expand the current indication to patients who have received at least 1 prior therapy.


1. Plesner T, Arkenau HT, 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]