A Randomized Study of Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma Who Are Minimal Residual Disease Positive After Frontline Autologous Stem Cell Transplant

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Multiple Myeloma
  • Age: Between 18 - 79 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    In order to participate in this study, the following criteria must be met: 1) Have newly diagnosed multiple myeloma with a history of 4 to 8 total cycles of induction with or without consolidation therapy and have received HDT and ASCT. 2) For patients treated with consolidation therapy, the patient must be within 60 days of the last dose of consolidation therapy at the time of randomization. 3) Must have a VGPR or better response assessed per IMWG 2016 criteria at the time of randomization.

You may not be eligible for this study if the following are true:

  • You will not be able to participate in this study if you have the following : 1) Have any prior or concurrent invasive malignancy (other than multiple myeloma) within 5 years of date of randomization (exceptions are adequately treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other non-invasive lesion that in the opinion of the investigator, and concurrence by the sponsor’s medical monitor, is considered cured with minimal risk of recurrence within 3 years). 2) Have had prior treatment/therapy with: a. Anti-CD38 antibody at any time, b. Radiation within 14 days of randomization, or c. Plasmapheresis within 28 days of randomization. 3) Be exhibiting clinical signs of meningeal or central nervous system involvement due to multiple myeloma.

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