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A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination with Bortezomib (Velcade), Lenalidomide (Revlimid) and Dexamethasone versus Bortezomib, Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant

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Trial Profile

A Phase 3 Randomized, Open-label, Multicenter Study Assessing the Clinical Benefit of Isatuximab (SAR650984) in Combination with Bortezomib (Velcade), Lenalidomide (Revlimid) and Dexamethasone versus Bortezomib, Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma (NDMM) Not Eligible for Transplant

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

Latest Information Update: 23 Apr 2024

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At a glance

  • Drugs Isatuximab (Primary) ; Bortezomib; Bortezomib; Dexamethasone; Dexamethasone; Diphenhydramine; Lenalidomide; Paracetamol; Ranitidine
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms IMROZ
  • Sponsors Sanofi; Sanofi-Aventis Recherche & Developpement
  • Most Recent Events

    • 07 Dec 2023 According to a Sanofi media release, based on the interim analysis, the study met its primary endpoint demonstrating statistically significant improvement in progression-free survival (PFS) compared with VRd alone.
    • 07 Dec 2023 According to a Sanofi media release, the use of Sarclisa in combination with VRd has not been fully evaluated by any regulatory authority.
    • 07 Dec 2023 According to a Sanofi media release, Thierry Facon, Professor of Haematology in the Department of Haematology, Lille University Hospital, Lille, France, member of French Academy of Medecine is a Principal Investigator of this study.
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