Addtion of Daratumumab to Standard Tx Assessed in Multiple Myeloma
HealthDay News — Bortezomib, melphalan, and prednisone, combined with daratumumab is associated with a lower risk of disease progression or death for patients with newly diagnosed multiple myeloma who are ineligible for stem-cell transplantation, according to a study published online December 12 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Hematology, held from December 9 to 12 in Atlanta.
Maria-Victoria Mateos, MD, PhD, from the University Hospital of Salamanca in Spain, and colleagues randomized 706 patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation to receive nine cycles of bortezomib, melphalan, and prednisone either alone or with daratumumab until disease progression.
The researchers found that the 18-month progression-free survival rate was 71.6% and 50.2% in the daratumumab and control groups, respectively, at a median follow-up of 16.5 months (hazard ratio for disease progression or death, 0.50). The overall response rate was 90.9 and 73.9%, respectively, and rate of complete response or better was 42.6 and 24.4%, respectively. In the daratumumab and control groups, 22.3 and 6.2%, respectively, had results below the threshold for minimal residual disease.
"Among patients with newly diagnosed multiple myeloma who were ineligible for stem-cell transplantation, daratumumab combined with bortezomib, melphalan, and prednisone resulted in a lower risk of disease progression or death than a regimen without daratumumab," the authors write.
The study was funded by Janssen Research and Development, the manufacturer of daratumumab.