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

Completed · Phase 1/Phase 2

Conditions studied: Amyloidosis

In brief

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.

Key facts

Study ID

NCT00298766

Run by

Millennium Pharmaceuticals, Inc.

People needed

70

Starts

2005-06-01

Expected to finish

2009-09-01

Last updated by the study team

2012-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Hypersensitivity to boron or mannitol
• Prior treatment with VELCADE
• Patient requires other concomitant chemotherapy, radiotherapy or ancillary therapy considered investigational
• Uncontrolled infection

Where it is running

• Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute — Los Angeles, California, United States
• Winship Cancer Center - Emory Clinic School of Medicine — Atlanta, Georgia, United States
• Boston Medical Center — Boston, Massachusetts, United States
• MSKCC — New York, New York, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.