Subcutaneous Daratumumab with Standard Multiple Myeloma Tx

March 15, 2019

A Multicenter Phase 2 Study to Evaluate Subcutaneous Daratumumab in Combination with Standard Multiple Myeloma Treatment Regimens

  • Clinical Trial Information

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

    Trial Phone: 321.841.1907 ; 321.841.7293

  • IRB No: 18.033.03

    Protocol Abbrev: MMY2040

    Principal Investigator: Julio J. Hajdenberg, MD

    Phase: Drug: Phase II

    Age Group: Adult

    Secondary Protocol No: 54767414MMY2040

    Treatment: Daratumumab administered SC to standard MM regimens

    Therapies Involved: Oncology: 1st line;Oncology: 2nd line;Oncology: 3rd line/Refractory

    ClinicalTrials.gov ID: NCT03412565

  • Objective

    The purpose of this study is to evaluate the clinical benefit of subcutaneous (SC) daratumumab administered in combination with standard multiple myeloma (MM) regimens in participants with MM as measured by overall response rate (ORR) or very good partial response (VGPR) or better rate

  • Key Eligibility

    18 years of age and older; documented secretory MM based on IMWG criteria, and an Eastern Cooperative Oncology Group (ECOG) performance status grade of 0, 1, or 2. Additional criteria are defined for each treatment cohort (D-VRd, D-VMP, and D-Rd).