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