(ChemotherapyAdvisor) – The combination of elotuzumab plus bortezomib showed encouraging activity in patients with relapsed/refractory multiple myeloma, a phase I study published in the Journal of Clinical Oncology online January 30 has found.
The trial enrolled 28 patients with relapsed/refractory multiple myeloma who had received ≤3 prior therapies (median=2) for their disease. Three patients each received 2.5, 5.0, and 10mg/kg IV elotuzumab, a humanized anti-CS1 monoclonal IgG1 antibody, on days 1 and 11 and bortezomib 1.3mg/m2 IV on days 1, 4, 8, and 11 in 21-day cycles.
The maximum-tolerated dose was not reached up to the maximum planned dose of 20mg/mg, reported Andrzej J. Jakubowiak, MD, PhD, University of Chicago Medical Center, Chicago, IL, and colleagues; an additional 19 patients received elotuzumab 20mg/kg, 6 during dose escalation and 13 during an expansion phase.
An objective response of partial response or better was observed in 13 of 27 evaluable patients (48%), including 2 of 3 refractory to bortezomib. Median time to progression was 9.46 months. The most frequent grade 3/4 adverse events (AEs) were lymphopenia in 25% of patients and fatigue in 14%. One patient had elotuzumab-related serious AEs of chest pain and gastroenteritis.
The investigators report a phase 3 study of elotuzumab in combination with lenalidomide and dexamethasone in relapsed multiple myeloma is ongoing.