A Multicenter Open-Label Phase II Study of Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma
Inclusion Criteria:
- 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 Criteria:
- 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