Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below
  • Phase III Study of Daratumumab/rHuPH20 (NSC- 810307) + Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Stud

    Cancer Categories
    • Hematologic (Blood Cancers)
    Karmanos Trial ID
    • S1803
    NCT ID
    • NCT04071457
    Age Group
    • Adult
    Scope
    • National
    PhaseClick for Clinical Trial Phase DefinitionPhase III
    Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug
    • Phase III
    Principal Investigator
    • Andrew
      Kin, M.D.

      Oncology - Hematology, Oncology - Medical View Profile

    Objective:

    Primary Objective:
    • To compare overall survival (OS) between the two treatment arms with lenalidomide as the comparator arm and lenalidomide + daratumumab/rHuPH20 as the experimental arm in post-autologous transplant multiple myeloma (MM) patients.
    Secondary Objectives of First Randomization:
    • To compare the best overall response rate (ORR), including partial remission (PR), very good partial remission (VGPR), and complete remission (CR, sCR) in the subset of patients not in PR at randomization to lenalidomide versus lenalidomide + daratumumab/rHuPH20 in this patient population.
    • To compare progression-free survival (PFS) between the study arms in this patient population.
    • To evaluate MRD-negativity on the two treatment arms at randomization (Registration Step 2), and to compare MRD-negativity rate at 12, 24 (second randomization), 36, and 48 months after first randomization between lenalidomide and lenalidomide + daratumumab/rHuPH20 in this patient population.
    • To compare toxicities and tolerability of long term therapy between the study arms.
    Objectives of Second Randomization:
    • To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide vs. discontinued lenalidomide from the time of second randomization in this patient population.
    • To compare overall survival (OS) between MRD negative patients randomized to continued lenalidomide + daratumumab/rHuPH20 vs. discontinued lenalidomide + daratumumab/rHuPH20 from time of second randomization in this patient population.
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    Detroit, MI 48201
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    Lansing, MI 48912
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    Lansing, MI 48912
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    Petoskey, MI 49770
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    Port Huron, MI 48060
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