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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: 15 Aug 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

    • 25 Jul 2024 According to a Sanofi media release, regulatory decision by US FDA expected in second half of this year and other regulatory submissions are currently under review in the EU, Japan, and China, regulatory decision expected in H1 2025.
    • 04 Jun 2024 Results assessing efficacy and safety of isatuximab, bortezomib, lenalidomide, and dexamethasone vs bortezomib, lenalidomide, and dexamethasone in transplant-ineligible NDMM patients, presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
    • 03 Jun 2024 Results from this trial presented in a Sanofi media release.

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