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Recombinant monoclonal antibody therapy is an emerging option for patients with relapsed myeloma (NEJM JW Oncol Hematol Nov 2015 and N Engl J Med 2015; 373:621). In an industry-funded, phase I/II trial, investigators tested daratumumab, an anti-CD38 antibody, in heavily pretreated myeloma patients with active disease. Two dose levels were studied in the phase II portion of the trial: 8 mg/kg or 16 mg/kg given weekly for 8 doses, then twice monthly for 8 doses, then monthly for 24 months.
Patients had a median of four prior treatment regimens, including 76% who had prior autologous stem cell transplantation. Most patients were resistant to immunomodulatory agents and proteasome inhibitors.
A higher response rate was observed with the 16-mg dos…