Velcade Combined With High-Dose Dexamethasone in Patients With Newly Diagnosed Multiple Myeloma

Nantes University Hospital (NUH)

Status and phase

Terminated

Phase 2

Conditions

Multiple Myeloma

Treatments

Drug: velcade

Drug: Dexamethasone

Study type

Interventional

Funder types

Other

Identifiers

NCT00337506

BRD 03/6-E

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy and safety of Velcade plus dexamethasone used as induction chemotherapy prior to autologous transplantation.

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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