Recently, results of a phase 3 trial performed by Antonio Palumbo, MD and other CASTOR investigators was published in the New England Journal of Medicine (N Engl J Med. 2016; 375:754-766) demonstrating the efficacy of daratumumab (16 mg/kg), an anti-CD38 monoclonal antibody, with bortezomib (1.3 mg/m2) plus dexamethasone (20 mg) in treatment of patients with relapses or relapsed and refractory multiple myeloma (n=498).
Specifically, the progression-free survival (60.7% vs 26.9%), overall response (82.9% vs 63.2%), very good partial response or better (59.2% vs 29.1%), and complete response (19.2% vs 9.0%) was superior in the daratumumab with bortezomib plus dexamethasone group than the bortezomib plus dexamethasone group alone. Results also showed that infusion-related reactions, thrombocytopenia, and neutropenia rates were higher in the former than the latter group.
The study was funded by Janssen Research and Development; ClinicalTrials.gov number, NCT02136134.)