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A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma

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Trial Profile

A Randomized Phase III Trial Assessing the Benefit of the Addition of Isatuximab to Lenalidomide / Bortezomib / Dexamethasone (RVd) Induction and Lenalidomide Maintenance in Patients With Newly Diagnosed Multiple Myeloma

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

Latest Information Update: 30 Jun 2025

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At a glance

  • Drugs Isatuximab (Primary) ; Lenalidomide (Primary) ; Bortezomib; Cyclophosphamide; Dexamethasone; Dexamethasone; Doxorubicin; Melphalan; Stem cell therapies
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms GMMG-HD7

Most Recent Events

  • 23 Jun 2025 According to a Sanofi media release, European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the induction treatment of adult patients with newly diagnosed multiple myeloma (NDMM) who are eligible for autologous stem cell transplant. The positive CHMP opinion is based on part one results from this study.
  • 24 Jan 2025 Planned End Date changed from 1 Dec 2025 to 1 Mar 2027.
  • 10 Dec 2024 According to an abstract presented at the 66th American Society of Hematology Annual Meeting and Exposition, Primary endpoint has been met. (Progression Free Survival (PFS) after second randomization (arms IIA and IIB))

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