Multiple Myeloma
Conditions
Keywords
Newly Diagnosed, multiple myeloma, induction, Thalidomide
Brief summary
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).
Interventions
DRUGVelcade-Dexamethasone
DRUGVelcade-Thalidomide-Dexamethasone
Sponsors
Intergroupe Francophone du Myelome
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Countries
Belgium, France
Outcome results
None listed