(HealthDay) -- For patients with relapsed or refractory multiple myeloma, combination treatment with elotuzumab, lenalidomide, and low-dose dexamethasone is generally well tolerated, with encouraging response rates, according to a study published online April 30 in the Journal of Clinical Oncology.
Sagar Lonial, M.D., of the Winship Cancer Institute at Emory University in Atlanta, and colleagues conducted a phase I study to evaluate the dose-limiting toxicities and response rates associated with elotuzumab, lenalidomide, and low-dose dexamethasone treatment in 28 patients with relapsed or refractory multiple myeloma (median, three prior multiple myeloma therapies). Patients were treated with 5, 10, or 20 mg/kg elotuzumab, plus lenalidomide and dexamethasone.
The researchers found no dose-limiting toxicities up to the maximum 20-mg/kg dose of elotuzumab. Neutropenia (36 percent) and thrombocytopenia (21 percent) were the most frequently reported grade 3 or 4 toxicities. Two serious infusion reactions, including one grade 4 anaphylactic reaction and one grade 3 stridor, occurred in two patients during the first treatment cycle. A total of 82 percent of patients exhibited objective responses. For patients treated until disease progression, after a median of 16.4 months follow-up, the median time to progression was not reached for patients in the 20-mg/kg cohort.
"The combination of elotuzumab, lenalidomide, and dexamethasone appears to be active, with results from this phase I study suggesting enhanced efficacy over lenalidomide and low-dose dexamethasone alone," the authors write. "Further validation of the dose, safety, and efficacy in larger patient populations is warranted and underway."
More information: doi: 10.1200/JCO.2011.37.2649