Status:
COMPLETED
A Study of Bortezomib, Cyclophosphamide, and Dexamethasone in Patients With Untreated Multiple Myeloma and Planned for a High Dose Chemotherapy
Lead Sponsor:
Janssen-Cilag G.m.b.H
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
Brief 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.
Detailed Description
This is open-label (both the participant and the investigator know what treatment participants will receive), prospective (participants are identified and then followed forward in time for the outcome...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
401 Patients enrolled
Trial Details
Trial ID
NCT00833560
Start Date
March 1 2006
End Date
June 1 2009
Last Update
November 21 2014
Active Locations (34)
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1
Berg, Germany
2
Berlin, Germany
3
Bremen, Germany
4
Dresden, Germany