VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Completed · Phase 2

Conditions studied: Mantle Cell Lymphoma

In brief

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

Key facts

Study ID

NCT00063713

Run by

Millennium Pharmaceuticals, Inc.

People needed

152

Starts

2003-06-01

Last updated by the study team

2008-02-11

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Alta Bates Medical Center — Berkeley, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Loma Linda Cancer Research Institute — Loma Linda, California, United States
• UCLA School of Medicine — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of Colorado Cancer — Denver, Colorado, United States
• Georgetown University Medical Center Lombardi Cancer Center — Washington D.C., District of Columbia, United States
• H. Lee Moffitt Cancer Center & Research Institute — Tampa, Florida, United States
• The Emory Clinic — Atlanta, Georgia, United States
• The Rush Cancer Center — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Indiana University Cancer Center — Indianapolis, Indiana, United States
• University of Iowa Hospital Division — Iowa City, Iowa, United States
• North Memorial Hospital — Robbinsdale, Minnesota, United States
• Onc/Hem Associates of Kansas City — Kansas City, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Beth Israel Medical Center — New York, New York, United States
• St Lukes-Roosevelt Hospital — 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
• University of Rochester Medical Center — Rochester, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Wake Forest, University health Sciences/Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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