A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With VBMCP-VBAD/Velcade Versus Thalidomide / Dexamethasone Versus Velcade / Thalidomide / Dexamethasone Followed by High Dose Intensive Therapy With Autologous Hemopoietic Stem Cell Support and Maintenance Treatment With Interferon-a Versus Thalidomide Versus Thalidomide / Velcade in Untreated Patients With Multiple Myeloma Less Than 65 Yrs Old

Trial Profile

A National, Open-Label, Multicenter, Randomized, Comparative Phase III Study of Induction Treatment With VBMCP-VBAD/Velcade Versus Thalidomide / Dexamethasone Versus Velcade / Thalidomide / Dexamethasone Followed by High Dose Intensive Therapy With Autologous Hemopoietic Stem Cell Support and Maintenance Treatment With Interferon-a Versus Thalidomide Versus Thalidomide / Velcade in Untreated Patients With Multiple Myeloma Less Than 65 Yrs Old

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Sep 2017

At a glance

  • Drugs Bortezomib (Primary) ; Carmustine; Cyclophosphamide; Dexamethasone; Doxorubicin; Interferon alpha-2b; Melphalan; Prednisone; Thalidomide; Vincristine
  • Indications Multiple myeloma
  • Focus Registrational; Therapeutic Use
  • Acronyms Pethema/GEM Study
  • Most Recent Events

    • 01 Sep 2017 Results related to 3-year maintenance period published in the Leukemia
    • 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.
    • 08 Aug 2013 The European Commission has approved bortezomib induction therapy in combination with dexamethasone or thalidomide + dexamethasone based on the analysis of data from this trial, according to a Janssen-Cilag media release.
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