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

 -  Compare the complete remission (CR) rates (i.e., the true CR, with negative
 immunofixation) achieved with either four courses of VD or four courses of VTD.

 Secondary objectives:

 -  Compare the following parameters following 4 cycles of VD or VTD induction treatment:

 -  CR rate+ very good partial remission (VGPR) rate

 -  Overall remission rate (CR + VGPR + partial remission (PR) rate)

 -  K/l light chain ratio in patients in CR.

 -  Safety (quality of the sampled stem cells, extrahaematological and haematological
 toxicity: specially neurological toxicity, length of hospitalization).

 -  Compare the CR rate and the CR + VGPR rates after post-induction autologous stem cell
 transplantation (ASCT).
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)