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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Treatments: BB 1101; Bortezomib; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

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