Daratumumab Combination Therapy in Newly Diagnosed Multiple Myeloma
Posted: Monday, March 26, 2018
The use of daratumumab combined with other standard-of-care regimens in patients with relapsed or refractory multiple myeloma resulted in improved survival benefits, but more grade 3 or 4 infections, according to findings published in The New England Journal of Medicine. The study, led by María-Victoria Mateos, MD, of the University Hospital of Salamanca–Instituto de Investigación Biomédica de Salamanca in Spain, compared the use of daratumumab with and without bortezomib, melphalan, and prednisone.
In the phase III trial, researchers analyzed 706 patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplantation. Patients received nine cycles of bortezomib, melphalan, and prednisone (control group) or that same combination of treatment with daratumumab.
Patients treated with daratumumab displayed longer rates of progression-free survival (71.6%) than the control group (50.2%), as well as a better overall response rate (90.9% vs. 73.9%). In the daratumumab group, 22.3% of patients tested negative for minimal residual disease, compared with 6.2% of their non-daratumumab counterparts. Both groups had similar rates of grade 3 or 4 adverse events (hematologic neutropenia, thrombocytopenia, and anemia).
The rate of grade 3 or 4 infections was higher with daratumumab (23.1% vs. 14.7%), although the rate of treatment discontinuation because of infections was slightly lower (0.9% vs. 1.4%, respectively). Researchers observed daratumumab-associated infusion-related reactions in 27.7% of the patients.