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

Phase 2
18 Years
Not Enrolling
Mantle Cell Lymphoma

Thank you

Trial Information

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

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.

Inclusion Criteria

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

- 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

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

Related Keywords:

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



University of Alabama Birmingham, Alabama  
Memorial Sloan Kettering Cancer Center New York, New York  10021
MD Anderson Cancer Center Houston, Texas  77030-4096
UCLA School of Medicine Los Angeles, California  900121973
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Pennsylvania Cancer Center Philadelphia, Pennsylvania  19104
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
Stanford University Stanford, California  94305
Beth Israel Medical Center New York, New York  10003
Western Pennsylvania Hospital Pittsburgh, Pennsylvania  15224
University of Rochester Medical Center Rochester, New York  14642
University of Nebraska Medical Center Omaha, Nebraska  68198-3330
City of Hope Comprehensive Cancer Center Duarte, California  91010
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
Vanderbilt University Nashville, Tennessee  37232-6305
University of North Carolina Chapel Hill, North Carolina  27599
Cancer Care Associates Tulsa, Oklahoma  74136
University of Chicago Medical Center Chicago, Illinois  60637
H. Lee Moffitt Cancer Center & Research Institute Tampa, Florida  33612
Sarah Cannon Cancer Center Nashville, Tennessee  37203
Oregon Health Science University Portland, Oregon  97239
Alta Bates Medical Center Berkeley, California  94704
Loma Linda Cancer Research Institute Loma Linda, California  92354
University of Colorado Cancer Denver, Colorado  80262
Georgetown University Medical Center Lombardi Cancer Center Washington, District of Columbia  20007
The Emory Clinic Atlanta, Georgia  30322
The Rush Cancer Center Chicago, Illinois  60612
University of Iowa Hospital Division Iowa City, Iowa  52242
North Memorial Hospital Robbinsdale, Minnesota  55422
Onc/Hem Associates of Kansas City Kansas City, Missouri  64111
St Lukes-Roosevelt Hospital New York, New York  10019
New York Hospital Cornell Medical Center New York, New York  10021
Wake Forest, University health Sciences/Comprehensive Cancer Center Winston-Salem, North Carolina  27157
University Hospital-Madison Wisconsin Madison, Wisconsin  53792