Open-Label Phase 1/2 Study of VELCADE for Injection in Patients With Light-chain (AL)-Amyloidosis

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Millennium Pharmaceuticals, Inc.
• Collaborator: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
• Treatments: Bortezomib

Criteria

Inclusion Criteria:

1. Male or Female 18 y/o and older

2. Female patients must be practicing an effective method of birth control

3. Biopsy-proven AL-amyloidosis

4. Must have been previously treated (failed at least 1 previous treatment) and in the opinion of the physician, patient requires further treatment

Exclusion Criteria:

1. Hypersensitivity to boron or mannitol

2. Prior treatment with VELCADE

3. Patient requires other concomitant chemotherapy, radiotherapy or ancillary therapy considered investigational

4. Uncontrolled infection