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

Completed
Phase of Trial: Phase III

Latest Information Update: 25 Jun 2017

At a glance

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

    • 25 Jun 2017 Results validating the use of Serum-Free Light-Chains (sFLC) assay in patients being treated in GEM/PETHEMA clinical trials (GEM05menos65, GEM05MAS65, GEM2010MAS65 and GEM2012menos65), presented at the 22nd Congress of the European Haematology Association.
    • 06 May 2017 Status changed from active, no longer recruiting to completed.
    • 07 Dec 2016 Planned End Date changed from 1 May 2019 to 1 May 2018.
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