VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Mantle Cell Lymphoma Clinical Trial

Official title:

A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063713
• Other study ID #: M34103-053
• Status: Completed
• Phase: Phase 2
• First received: July 2, 2003
• Last updated: February 7, 2008
• Start date: June 2003

Study information

• Verified date: February 2008
• Source: Millennium Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.

Description:

VELCADE is approved in multiple myeloma for patients who have received two prior therapies and their disease came back or got worse while on their second therapy. VELCADE is currently being studied in other types of cancers.

Other known NCT identifiers

• NCT00084851

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• 18 years of age or older

• Confirmed diagnosis of mantle cell lymphoma

• Documented relapse or progressive disease following 1 or 2 prior lines of anti-cancer therapy. At least one of those regimens must have included an anthracycline or mitoxantrone. Relapsed or progressive disease, since last therapy must be documented by new lesions or objective evidence of the progression of existing lesions.

• At least 1 measurable or evaluable site of disease

• Voluntary consent

Exclusion Criteria

• Previous treatment with VELCADE

• Any experimental or anti-cancer therapy within 3 weeks before the first dose of study drug

• Radiation therapy within 3 weeks before the first dose of study drug

• Major surgery with 2 weeks before the first dose of study drug

• Rituximab, Campath, or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug

• Radioimmunotherapy or other toxin immunoconjugates such as Zevalin or Bexxar within 10 weeks before the first dose of study drug

• History of allergic reactions to boron or mannitol compounds

• Diagnosed or treated for another malignancy other than mantle cell lymphoma with 5 years before the first dose of study drug

• Active systemic infection requiring treatment

• Women patients must not be pregnant or breast-feeding, confirmed through pregnancy test obtained during screening (this test is not required for women who are post-menopausal or surgically sterile)

• Serious medical or psychiatric illness likely to interfere with participation in this clinical study

• Concurrent treatment with another investigational drug or participation in non-treatment studies is not allowed if it interferes with participation in this clinical study

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Mantle-Cell
• Mantle Cell Lymphoma

Intervention

Drug:
• VELCADE TM (bortezomib) for Injection

Locations

Country	Name	City	State
United States	The Emory Clinic	Atlanta	Georgia
United States	Alta Bates Medical Center	Berkeley	California
United States	University of Alabama	Birmingham	Alabama
United States	University of North Carolina	Chapel Hill	North Carolina
United States	The Rush Cancer Center	Chicago	Illinois
United States	University of Chicago Medical Center	Chicago	Illinois
United States	University of Colorado Cancer	Denver	Colorado
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	MD Anderson Cancer Center	Houston	Texas
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	University of Iowa Hospital Division	Iowa City	Iowa
United States	Onc/Hem Associates of Kansas City	Kansas City	Missouri
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	Loma Linda Cancer Research Institute	Loma Linda	California
United States	UCLA School of Medicine	Los Angeles	California
United States	University Hospital-Madison Wisconsin	Madison	Wisconsin
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Vanderbilt University	Nashville	Tennessee
United States	Beth Israel Medical Center	New York	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New York Hospital Cornell Medical Center	New York	New York
United States	St Lukes-Roosevelt Hospital	New York	New York
United States	Cancer Care Associates	Oklahoma City	Oklahoma
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Stanford University	Palo Alto	California
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	University of Pennsylvania Cancer Center	Philadelphia	Pennsylvania
United States	Western Pennsylvania Hospital	Pittsburgh	Pennsylvania
United States	Oregon Health Science University	Portland	Oregon
United States	North Memorial Hospital	Robbinsdale	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	H. Lee Moffitt Cancer Center & Research Institute	Tampa	Florida
United States	Cancer Care Associates	Tulsa	Oklahoma
United States	Georgetown University Medical Center Lombardi Cancer Center	Washington	District of Columbia
United States	Wake Forest, University health Sciences/Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Millennium Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States,