A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy

• Status: Completed
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and effectiveness of bortezomib in combination with a standard regimen of cyclophosphamide and dexamethasone.

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

Details

• Lead Sponsor: Janssen-Cilag G.m.b.H
• Treatments: BB 1101; Bortezomib; Cyclophosphamide; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• Cytologically or histologically diagnosed with multiple myeloma stage II/III

• Participants without preceding cytostatic (tending to retard cellular activity and multiplication) treatment (pretreatment with radiation or dexamethasone is allowed)

• Agree to use one of the contraception methods as defined in the protocol

• Karnofsky performance status 60 percent or more

• Adequate laboratory test values

Exclusion Criteria:

• Non-secretory multiple myeloma

• Estimated life expectancy less than 3 months

• History of cancer (except basal cell carcinoma) in the last 5 years

• Peripheral neuropathy (disorder of the peripheral nerves) grade 2 or more

• Positive human immunodeficiency virus test and active hepatitis B and/or hepatitis C

• Pregnant or breast-feeding female participants