Status:
COMPLETED
Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis
Lead Sponsor:
Millennium Pharmaceuticals, Inc.
Collaborating Sponsors:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Amyloidosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
This is a phase 1/2 open-label, dose-escalation study investigating single-agent therapy with VELCADE in patients with previously treated systemic AL-amyloidosis who require further treatment.
Eligibility Criteria
Inclusion
- Male or Female 18 y/o and older
- Female patients must be practicing an effective method of birth control
- Biopsy-proven AL-amyloidosis
- Must have been previously treated (failed at least 1 previous treatment) and in the opinion of the physician, patient requires further treatment
Exclusion
- Hypersensitivity to boron or mannitol
- Prior treatment with VELCADE
- Patient requires other concomitant chemotherapy, radiotherapy or ancillary therapy considered investigational
- Uncontrolled infection
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT00298766
Start Date
June 1 2005
End Date
September 1 2009
Last Update
June 25 2012
Active Locations (4)
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1
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States, 90049
2
Winship Cancer Center - Emory Clinic School of Medicine
Atlanta, Georgia, United States, 30322
3
Boston Medical Center
Boston, Massachusetts, United States, 02118
4
MSKCC
New York, New York, United States, 10017