Status:
COMPLETED
IFM 2005-01: Velcade/Dexamethasone Versus Vincristine/Adriamycin (Doxorubicin)/Dexamethasone (VAD) for the Treatment of Patients With Multiple Myeloma
Lead Sponsor:
Nantes University Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
This is an open-label, multi-centre, randomised Phase III study, looking at a series of 480 patients up to the age of 65 with newly diagnosed multiple myeloma (MM) not previously treated. They will re...
Detailed Description
After their written informed consent has been obtained and their eligibility verified, patients are randomised between 4 treatment arms: A1 VAD (4 cycles); A2 VAD (4 cycles) followed by DCEP (2 cycles...
Eligibility Criteria
Inclusion
- Recently diagnosed MM according to the criteria of the South West Oncology Group (SWOG)
- Not previously treated, apart from local radiotherapy, in the case of a threatening or incapacitating lesion, and/or a 4-day block of dexamethasone (40 mg/mL) in an emergency
- Stage II or III disease according to the Durie and Salmon classification or Stage I disease with symptomatic bone lesion
- \< 65 years of age
- Ability to give signed informed consent
- Secretion of a measurable monoclonal spike (\> 10 g/l in the serum or 0.2 g/24h in the urine)
- Negative pregnancy test at inclusion (if necessary)
- Absence of active infection. In the case of infection, appropriate antibiotic therapy must be administered and patients must have been apyretic for 48 hours before the start of treatment with VAD or Velcade®/dexamethasone
Exclusion
- ECOG performance status \> 2
- History of cancer (other than basal cell carcinoma or carcinoma of the cervix in situ)
- Life expectancy \< 2 months
- Confirmed amyloidosis
- Positive HIV serology
- Serious psychiatric item in the history
- Renal failure requiring dialysis
- Uncontrolled diabetes, contra-indicating the use of corticosteroids
- Peripheral neuropathy National Cancer Institute (NCI) grade \> 2 (Annex 5)
- Clinical signs of heart failure or coronary heart disease
- Bilirubin \> 3 x normal
- Transaminases or gamma-glutamyl transpeptidase (GT) \> 4 x normal
- Platelets \< 50 x 10\^9/l during the 15 days prior to inclusion
- Neutrophils \< 0.75 x 10\^9/l during the 15 days prior to inclusion
- Use of an investigational medicinal product during the 30 days prior to inclusion
- Known hypersensitivity to bortezomib, boron or mannitol
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
493 Patients enrolled
Trial Details
Trial ID
NCT00200681
Start Date
June 1 2005
End Date
June 1 2008
Last Update
February 5 2009
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de Nantes, Service d'Hématologie
Nantes, France, 44093