Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
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Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.
life expectancy < 2 months
ECOG performance status > 2 (annex 3)
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