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)