(HealthDay News) – 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, MD, 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 5mg/kg, 10mg/kg, or 20mg/kg elotuzumab, plus lenalidomide and dexamethasone.
The researchers found no dose-limiting toxicities up to the maximum 20mg/kg dose of elotuzumab. Neutropenia (36%) and thrombocytopenia (21%) 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% 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 20mg/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.”
Several authors disclosed financial ties to pharmaceutical companies, including Abbott, which funded the study and manufactures elotuzumab.