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A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

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Trial Profile

A Phase 3 Study Comparing Daratumumab, VELCADE (Bortezomib), Lenalidomide, and Dexamethasone (D-VRd) With VELCADE, Lenalidomide, and Dexamethasone (VRd) in Subjects With Untreated Multiple Myeloma and for Whom Hematopoietic Stem Cell Transplant is Not Planned as Initial Therapy

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

Latest Information Update: 02 Apr 2025

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At a glance

  • Drugs Daratumumab (Primary) ; Daratumumab/hyaluronidase (Primary) ; Bortezomib; Dexamethasone; Dexamethasone; Lenalidomide
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms CEPHEUS
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 28 Feb 2025 According to a Johnson & Johnson media release, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of an indication extension of DARZALEX (daratumumab) subcutaneous (SC) formulation in the frontline setting.
    • 10 Dec 2024 According to an abstract presented at the 66th American Society of Hematology Annual Meeting and Exposition, Primary endpoint (Percentage of Participants with Negative Minimal Residual Disease (MRD) Status) has been met.
    • 10 Dec 2024 Results (n=395) reporting an expanded analysis of MRD outcomes , presented at the 66th American Society of Hematology Annual Meeting and Exposition

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