Elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma demonstrated acceptable safety and efficacy that appears to be better than that previously observed with lenalidomide and dexamethasone alone, a new study published online ahead of print in the journal The Lancet Haematology has shown.1
For the multicenter, open-label phase 1b/2 study, researchers enrolled 73 patients with relapsed multiple myeloma who had received 1 to 3 previous therapies but not lenalidomide. Patients were randomly assigned 1:1 to receive either 10 mg/kg or 20 mg/kg of intravenous elotuzumab plus lenalidomide 25 mg orally and dexamethasone 40 mg orally.
Elotuzumab was administered on days 1, 8, 15, and 22 during cycles 1 and 2 and days 1 and 15 during subsequent cycles. Patients received lenalidomide on days 1-21 and dexamethasone once weekly.
Results showed that 84% of patients achieved an objective response, 42% achieved a very good partial response, and 27% achieved a partial response.
In regard to safety, the most common treatment-related adverse events were diarrhea, muscle spasms, and fatigue. The most common grade 3 to 4 adverse events were lymphopenia and neutropenia.
Phase 3 trials are currently evaluating the combination of elotuzumab with lenalidomide and dexamethasone in patients with multiple myeloma.
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Elotuzumab is an immunostimulatory monoclonal antibody that targets lymphocytic activation molecule (SLAM) family member 7 (SLAMF7). It selectively kills SLAMF7-expressing myeloma cells through direct activation and engagement of the body’s immune system.
- Richardson PG, Jagannath S, Moreau P, et al. Elotuzumab in combination with lenalidomide and dexamethasone in patients with relapsed multiple myeloma: final phase 2 results from the randomised, open-label, phase 1b–2 dose-escalation study [published online ahead of print November 15, 2015]. Lancet Haematol. doi: 10.1016/S2352-3026(15)00197-0.