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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

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: 29 Jan 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

    • 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))
    • 10 Dec 2024 Results(Between Oct 2018 and Sep 2020, n=662 pts) exploring the impact of MRDneg and continued MRDneg on progression-free survival (PFS) , presented at the 66th American Society of Hematology Annual Meeting and Exposition

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