What is the role of daratumumab in the treatment of multiple myeloma (MM)?

Updated: Jul 15, 2019
  • Author: Dhaval Shah, MD; Chief Editor: Emmanuel C Besa, MD  more...
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Answer

A phase III study by the ALCYONE Trial Investigators found that the addition of daratumumab to the combination of bortezomib, melphalan, and prednisone in patients with newly diagnosed multiple myeloma who are ineligible for autologous stem-cell transplantation resulted in a lower risk of disease progression or death. [68] At a median follow-up of 16.5 months, results of treatment with and without daratumumab were as follows:

  • 18-month progression-free survival rate: 71.6% vs 50.2% 
  • Overall response rate: 90.9% vs 73.9% (P< 0.001)
  • Rate of complete response or better (including stringent complete response): 42.6% 24.4% (P< 0.001)

   However, the rate of grade 3 or 4 infections was 23.1% in the daratumumab group and 14.7% in the control group.

The MAIA trial was an open-label, randomized, phase 3 study comparing lenalidomide with low-dose dexamethasone with or without daratumumab in patients with newly diagnosed multiple myeloma ineligible for ASCT. The study demonstrated an improvement in progression-free survival in the daratumumab combination arm compared to the control arm. Patients with a complete response or better was 47.6% in the daratumumab group and 24.9% in the control group. A total of 24.2% of the patients in the daratumumab group, as compared with 7.3% of the patients in the control group, had results below the threshold for minimal residual disease (1 tumor cell per 105 white cells). [69]


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