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: Walton, Sherri; Manchola-Orozco, Carolina; Wyatt, Zachary M
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: NCT04071457
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.
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