Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)

Inclusion Criteria:

• Newly diagnosed symptomatic multiple myeloma (MM) patient
• Aged under 65
• Candidate for ASCT, with measurable levels of paraprotein in the serum (³ 10 g/L) or the urine (³ 200 mg/day)
• Using effective contraceptive methods (for fertile men, women of childbearing potential)
• Provision of informed consent
• No evidence of active infection

Exclusion Criteria:

• Asymptomatic MM
• Non-secretory MM
• Aged 66 years or over
• ECOG performance status over 2 (see Appendix 2)
• Proven amyloidosis
• A personal medical history of cancer (except for basocellular skin cancer or in situ cervical cancer)
• Positive HIV serology
• A personal medical history of severe psychiatric disease
• Severe diabetes contraindicating the use of high-dose dexamethasone
• NCI grade ³ 2 peripheral neuropathy

• Serum clinical chemistry:

  • creatinine level > 300 µmol/L or requiring dialysis
  • bilirubin, transaminases or GamaGT > 3 the upper normal limit (UNL)
• Prior or current systemic therapy for MM, including steroids (except for emergency use of a 4-day block of dexamethasone between the screening phase and randomization)
• Radiation therapy in the 2 weeks preceding randomization
• A personal medical history of allergic reactions to compounds containing boron or mannitol
• Non-controlled or severe cardiovascular disease (including a myocardial infarction in the 6 months prior to recruitment) or NYHA class III or IV renal failure
• Use of any investigational drug in the 30 days preceding randomization
• Pregnant or lactating women; a serum Beta-hCG pregnancy test must be performed during the screening phase for female patients of childbearing potential
• Severe pulmonary troubles (including acute infiltrative pneumopathy)