SC-Daratumumab + lenalidomide post-transplant for multiple myeloma
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)
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Clinical Trial Information
Trial Contact: Bobe Cortes, Estefania; Ribacchi, Stephanie
Trial Phone: 321.841.6626 ; 321-841-1077
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IRB No: S1803
Protocol Abbrev: S1803-DRAMMATIC
Principal Investigator: Hatem Hassanein, 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
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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.
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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
