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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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Oct 2019

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At a glance

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

    • 22 Aug 2019 According to a Genmab media release, the Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the use of DARZALEX (daratumumab) 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 approval is based on the data from this study.
    • 17 Dec 2018 According to Janssen Pharmaceuticals media release, Health Canada has approved DARZALEX (daratumumab), in combination with bortezomib, melphalan and prednisone (VMP), for the treatment of patients newly diagnosed with multiple myeloma who are ineligible for autologous stem cell transplantation.
    • 13 Dec 2018 According to a Genmab media release, based on the data of this study, the Janssen Pharmaceutical has submitted a supplemental new drug application (sNDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan, 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).
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