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

This study is currently recruiting participants.

Verified by Millennium Pharmaceuticals, Inc., January 2009

Sponsors and Collaborators:	Millennium Pharmaceuticals, Inc. Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by:	Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:	NCT00298766

Purpose

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.

Condition	Intervention	Phase
Amyloidosis	Drug: bortezomib	Phase I Phase II

Drug Information available for: Bortezomib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
Official Title:	An Open-Label Phase 1/2 Study of VELCADE (Bortezomib) for Injection in Subjects With Light-Chain (AL)-Amyloidosis

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:

To determine the maximum tolerated dose [ Time Frame: 8 cycles of treatment ] [ Designated as safety issue: No ]
To determine the safety of VELCADE [ Time Frame: 8 cycles of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To determine the hematologic response rate and duration of response at maximum tolerated dose. [ Time Frame: 8 cycles ] [ Designated as safety issue: No ]

Estimated Enrollment:	81
Study Start Date:	April 2005
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental VELCADE (Bortezomib)	Drug: bortezomib The dose of VELCADE will be drawn from the injection vial and administered as an i.v. bolus over 3 to 5 seconds followed by a standard saline flush. Once weekly at: 0.7, 1.0, 1.3 or 1.6 mg/m2(squared) Or Twice-weekly at: 0.7, 1.0, or 1.3 mg/m2(squared)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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 Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298766

Contacts

Contact: Millennium Medical and Drug Information Center

1-866-835-2233

medical@mlnm.com

Locations

United States, California
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute	Recruiting
Los Angeles, California, United States, 90049
United States, Georgia
Winship Cancer Center - Emory Clinic School of Medicine	Recruiting
Atlanta, Georgia, United States, 30322
United States, Massachusetts
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
United States, New York
MSKCC	Recruiting
New York, New York, United States, 10017

Sponsors and Collaborators

Millennium Pharmaceuticals, Inc.

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

More Information

Responsible Party:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C. ( Clinical Research Monitor )
Study ID Numbers:	26866138-CAN-2007
Study First Received:	March 1, 2006
Last Updated:	January 8, 2009
ClinicalTrials.gov Identifier:	NCT00298766
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Amyloidosis
Metabolic Diseases
Bortezomib
Metabolic disorder

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses

Enzyme Inhibitors
Pharmacologic Actions
Protease Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009