Status:
TERMINATED
Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Lead Sponsor:
Nantes University Hospital
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.
Eligibility Criteria
Inclusion
- diagnosis of MM according to the SWOG criteria (annex 1)
- previously untreated (localized radiotherapy is allowed)
- symptomatic MM stage II or III according to Durie-Salmon staging system (annex 2) or stage I with one symptomatic osteolytic lesion
- with measurable levels of paraprotein in the serum (\> 1g/dl) or in the urine (\> 0.2g/24h)
- age \< 75 years
- able to understand and to given an informed consent
- male, female without childbearing potential or negative urine pregnancy test within 72 hours prior to beginning the treatment. Women of childbearing potential must be following adequate contraceptive measures.
- no active systemic infection. In the presence of any active systemic infection, adequate broad-spectrum or organism-specific antibiotic coverage must be administered. Patients must be a febrile with stable vital signs while receiving antibiotics for at least 48 hours prior to beginning the treatment with Velcade plus dexamethasone.
Exclusion
- life expectancy \< 2 months
- ECOG performance status \> 2 (annex 3)
- proven amyloidosis
- positive HIV serology
- antecedents of severe psychiatric disease
- severe diabetes contraindicating the use of high-dose corticoïds
- \> NCI grade 2 peripheral neuropathy (Annex IV)
- serum biochemical values as follow
- creatinin level \> 200mmol/l
- bilirubin, transaminases or gGT \> 3 the upper normal limit
- use of any experimental drugs within 30 days of baseline
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00337506
Start Date
August 1 2003
Last Update
June 16 2006
Active Locations (1)
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1
Jean-Luc HAROUSSEAU
Nantes, France, 44093