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A Randomized, National, Open-label, Multicenter, Phase III Trial Studying Induction Therapy With Bortezomib/Lenalidomide/Dexamethasone (VRD-GEM), Followed by High-dose Chemotherapy With Melphalan-200 (MEL-200) Versus Busulfan-melphalan (BUMEL), and Consolidation With VRD-GEM in Patients Under 65 Years Old With Newly-diagnosed, Symptomatic Multiple Myeloma

Trial Profile

A Randomized, National, Open-label, Multicenter, Phase III Trial Studying Induction Therapy With Bortezomib/Lenalidomide/Dexamethasone (VRD-GEM), Followed by High-dose Chemotherapy With Melphalan-200 (MEL-200) Versus Busulfan-melphalan (BUMEL), and Consolidation With VRD-GEM in Patients Under 65 Years Old With Newly-diagnosed, Symptomatic Multiple Myeloma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jan 2024

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At a glance

  • Drugs Busulfan (Primary) ; Melphalan (Primary) ; Bortezomib; Dexamethasone; Lenalidomide
  • Indications Multiple myeloma
  • Focus Therapeutic Use
  • Acronyms PETHEMA/GEM2012
  • Most Recent Events

    • 12 Dec 2023 Results of an analysis assessing clinical impact of PRD and MRD dynamics in MM patients receiving intensive treatment from two clinical studies: GEM2012MENOS65 trial and GEM2014MAIN trial presented at the 65th American Society of Hematology Annual Meeting and Exposition
    • 06 Jun 2022 Results (n=374) from multiple myeloma patients enrolled in the GEM2012MENOS65 and GEM2014MAIN trials published in the Journal of Clinical Oncology
    • 14 Dec 2021 Results (n=164) assessing treatment response by immunofixation , next generation flow cytometry and mass spectrometry by deriving samples, presented at the 63rd American Society of Hematology Annual Meeting and Exposition
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