Adding a targeting agent to standard of care carfilzomib, lenalidomide, and dexamethasone (KRd) for multiple myeloma is a safe and efficacious alternative to autologous stem cell transplantation (ASCT) with KRd, according to research presented at the 2017 ASCO Annual Meeting (June2-6, 2017; Chicago, IL).
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The new regimen is also considered a feasible addition to induction therapy that does not negatively affect stem cell collection in newly diagnosed patients with multiple myeloma.
Standard treatment for multiple myeloma generally consists of a proteasome inhibitor or immunomodulatory drug plus ASCT. Daratumumab—a human immunoglobulin G1K monoclonal antibody targeting CD38 directly and indirectly through immunomodulation—has shown to induce durable response in combination with lenalidomide or bortezomib. Daratumumab was previously approved for use with standard of care for relapsed/refractory disease after one prior treatment regimen.
Andrzej J Jakubowiak, MD, PhD, University of Chicago Medical Center, and colleagues conducted an open-label, multicenter, phase Ib study to assess the effects of daratumumab as an alternative to ASCT in standard of care treatment in newly diagnosed multiple myeloma. Researchers enrolled 22 patients—regardless of their eligibility for ASCT—and subjected them to multiple 28-day cycles involving daratumumab (8 mg/kg on days 1 and 2 of cycle 1, and 16 mg/kg once weekly on cycles 1 and 2; every 2 weeks on cycles 3–6; and then every 4 weeks), carfilzomib (20 mg/m2), lenalidomide (35 mg on days 1-21 of each cycle), and dexamethasone (40 mg per week). Primary endpoints were safety and tolerability, with overall response rate (ORR) serving as a secondary endpoint.
After a median follow-up of 12 months, the median progression-free survival was 94% and the ORR was 100% for those patients who chose to continue treatment with daratumumab throughout the trial. Twenty-seven percent of patients experienced infusion-related reactions to daratumumab, including cough, throat irritation, nausea, and headache, though none of these reactions were grade 3 or 4.
“The addition of Daratumumab to KRd was well tolerated; the overall safety profile was consistent with that previously reported for KRd, with no additional toxicity observed with the addition of daratumumab,” authors of the study wrote. “These data support further investigation of daratumumab plus KRd as a frontline treatment regimen.”—Zachary Bessette
