SC-Daratumumab + lenalidomide post-transplant for multiple myeloma

August 20, 2019

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 STUDY)

  • Clinical Trial Information

    Trial Contact: Cevallos, Claudia; Manchola-Orozco, Carolina; Walton, Sherri

  • IRB No: S1803

    Protocol Abbrev: S1803 DRAMMATIC

    Principal Investigator: Daniel Ari Landau, MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: S1803

    Treatment: Patients will be randomized to receive either Arm 1: Lenalidomide or Arm 2: Lenalidomide + Daratumumab/rHuPH20

    Therapies Involved: Oncology: 2nd line

    ClinicalTrials.gov ID: PENDING

  • 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.

  • Key Eligibility

    Confirmed diagnosis of symptomatic multiple myeloma that required systemic induction therapy prior to autologous stem cell transplantation (ASCT).
    Patients must not be refractory to either lenalidomide or daratumumab/rHuPH20
    Patients must be ≥ 18 and ≤ 75 years of age