The combination of elotuzumab, lenalidomide, and dexamethasone is well tolerated and active in patients with high-risk smoldering multiple myeloma who would otherwise remain untreated, according to a study presented at the American Society of Hematology (ASH) 58th Annual Meeting and Exposition.1
Elotuzumab, a monoclonal antibody directed against signaling lymphocyte activation molecule family 7 (SLAMF7), is indicated in combination with lenalidomide and dexamethasone for the treatment of relapsed/refractory multiple myeloma.
Because current recommendations of therapy for smoldering multiple myeloma, a precursor to multiple myeloma, continue to be patient observation, researchers sought to evaluate the 3-drug elotuzumab combination in this patient population.
For the phase 2 study, researchers enrolled 39 patients with high-risk smoldering myeloma. All participants received elotuzumab 10 mg/kg intravenously weekly on days 1, 8, 15, and 22 for the first 2 28-day cycles in combination with lenalidomide orally daily on days 1 to 21 and dexamethasone. For cycles 3 to 8, patients received elotuzumab on days 1, 8, and 15. Patients were then eligible to continue on maintenance therapy with elotuzumab 20 mg/kg on day 1 and lenalidomide on days 1 to 21 of each 28-day cycle.
Results showed that 71% of the 34 evaluable patients achieved an overall response, including 9 very good partial responses and 15 partial responses. The clinical benefit rate was 97%.
Due to potential interference of elotuzumab with immunoelectrophoresis, researchers are evaluating whether some of the very good partial responses are possible complete responses.
Treatment-related grade 3 toxicities included hypophosphatemia in 23%, neutropenia in 8%, infection in 8%, and anemia, pulmonary embolism, rash, and diarrhea each in 3%. To date, investigators have not observed grade 4 or 5 toxicities.
The findings suggest that elotuzumab plus lenalidomide and dexamethasone represents a potential strategy for early intervention in patients with high-risk smoldering myeloma.
1. Ghobrial IM, Badros AZ, Vredenburgh JJ, et al. Phase II trial of combination of elotuzumab, lenalidomide, and dexamethasone in high-risk smoldering multiple myeloma. Paper presented at: American Society of Hematology (ASH) 58th Annual Meeting and Exposition; December 3-6, 2016; San Diego, CA.