Etude Multicentrique Ouverte Randomisée de Phase III Comparant l'Association de VELCADE®-Dexaméthasone à la Chimiothérapie de Type VAD Pour le Traitement Des Patients Porteurs de Myélome Multiple de Novo Jusqu'à l'âge de 65 Ans
After their written informed consent has been obtained and their eligibility verified,
patients are randomised between 4 treatment arms: A1 VAD (4 cycles); A2 VAD (4 cycles)
followed by DCEP (2 cycles); B1 Velcade® + dexamethasone (4 cycles); B2 Velcade® +
dexamethasone (4 cycles) followed by DCEP (2 cycles) A1, A2, B1, B2 + autograft.
Randomisation will be stratified on the basis of the initial b2 microglobulin level (> or <
3 mg/l) and the presence of chromosome 13 abnormalities identified by FISH analysis. VAD:
Vincristine/Adriamycin/Dexamethasone; DCEP: Dexamethasone/Cyclophosphamide/
Etoposide/Cisplatin.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
To compare the CR rate (with negative or positive immunofixation) obtained with VAD or the Velcade®/dexamethasone combination used as induction treatment in patients up to the age of 65 with newly diagnosed MM, at the end of this induction treatment
Jean-Luc Harousseau, MD PHD
Principal Investigator
Intergroupe Francophone du Myélome (IFM)
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
BRD 04/11-J
NCT00200681
June 2005
June 2008
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