Status:
UNKNOWN
Study in Myeloma Patients Newly Diagnosed Treated as an Induction With Velcade-Dex or Velcade (Bortezomib) Thalidomide Dexamethasone (VTD)
Lead Sponsor:
Intergroupe Francophone du Myelome
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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:...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT00910897
Start Date
March 1 2008
Last Update
June 1 2009
Active Locations (56)
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1
ANVERS Centrumziekenhuis
Antwerp, Belgium
2
Anvers Uza
Antwerp, Belgium
3
Bruxelles Erasme
Brussels, Belgium
4
Bruxelles I Bordet
Brussels, Belgium