Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Inclusion Criteria: * diagnosis of MM according to the SWOG criteria (annex 1) * previously untreated (localized radiotherapy is allowed) * symptomatic MM stage II or III according to Durie-Salmon staging system (annex 2) or stage I with one symptomatic osteolytic lesion * with measurable levels of paraprotein in the serum (\> 1g/dl) or in the urine (\> 0.2g/24h) * age \< 75 years * able to understand and to given an informed consent * male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures. * no active systemic infection. In the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. Patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with Velcade plus dexamethasone. Exclusion Criteria: * life expectancy \< 2 months * ECOG performance status \> 2 (annex 3) * proven amyloidosis * positive HIV serology * antecedents of severe psychiatric disease * severe diabetes contraindicating the use of high-dose corticoïds * \> NCI grade 2 peripheral neuropathy (Annex IV) * serum biochemical values as follow * creatinin level \> 200mmol/l * bilirubin, transaminases or gGT \> 3 the upper normal limit * use of any experimental drugs within 30 days of baseline