A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy

Trial Profile

A Phase 3, Randomized, Controlled, Open-label Study of VELCADE (Bortezomib) Melphalan-Prednisone (VMP) Compared to Daratumumab in Combination With VMP (D-VMP), in Subjects With Previously Untreated Multiple Myeloma Who Are Ineligible for High-dose Therapy

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 05 Apr 2018

At a glance

  • Drugs Daratumumab (Primary) ; Bortezomib; Melphalan; Prednisone
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms Alcyone
  • Sponsors Genmab; Janssen Biotech; Janssen Research & Development
  • Most Recent Events

    • 19 Jan 2018 According to a Genmab media release, the U.S. Food and Drug Administration (FDA) has granted Priority Review to the supplemental Biologics License Application (sBLA) for the use of daratumumab (DARZALEX) in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2018 to take a decision
    • 12 Dec 2017 Results of interim analysis assessing safety and efficacy published in the New England Journal of Medicine
    • 12 Dec 2017 Results published in the American Society of Hematology Media Release
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