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A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Previously Untreated Multiple Myeloma Who Are Eligible for High-dose Therapy

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Trial Profile

A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) vs VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Previously Untreated Multiple Myeloma Who Are Eligible for High-dose Therapy

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

Latest Information Update: 12 Apr 2024

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At a glance

  • Drugs Bortezomib (Primary) ; Daratumumab/hyaluronidase (Primary) ; Dexamethasone; Lenalidomide
  • Indications Multiple myeloma; Plasmacytoma
  • Focus Therapeutic Use
  • Acronyms Perseus

    • Most Recent Events

    • 06 Mar 2024 According to a Johnson & Johnson media release, the company announced the submission of a Type II variation application to the European Medicines Agency (EMA).The submission is seeking approval for an indication extension of DARZALEX (daratumumab) subcutaneous (SC) formulation in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant.
    • 30 Jan 2024 According to Janssen media release, Based on data from this study the company submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the approval of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for treatment of patients with newly diagnosed multiple myeloma (NDMM) and autologous stem cell transplant (ASCT).
    • 12 Dec 2023 Primary Results presented at the 65th American Society of Hematology Annual Meeting and Exposition
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