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VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00085696
Recruitment Status : Completed
First Posted : June 15, 2004
Last Update Posted : February 11, 2008
Information provided by:
Millennium Pharmaceuticals, Inc.

Brief Summary:
The purpose of this study is to evaluate the safety and effectiveness of VELCADE when given in combination with rituximab in patients with Relapsed or Refractory Indolent B-Cell Lymphoma. This study will investigate if treatment with VELCADE and rituximab increases the time it takes your lymphoma to get worse.

Condition or disease Intervention/treatment Phase
B-Cell Lymphoma Follicular Lymphoma Marginal Lymphoma Drug: VELCADE and rituximab Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of VELCADE® (Bortezomib) With Rituximab in Subjects With Relapsed or Refractory Indolent B-Cell Lymphoma
Study Start Date : May 2004
Actual Primary Completion Date : April 2006

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female subject 18 years or older
  • Diagnosis of B-cell lymphoma (CD20+) of

    • follicular lymphoma (grades 1, 2, and 3) or
    • marginal zone lymphoma (extranodal, nodal, and splenic)
  • Documented relapse or progression following prior anti-neoplastic treatment.
  • At least 1 measurable lymph node mass that is >1.5 cm.
  • No active CNS lymphoma
  • Voluntary consent

Exclusion Criteria:

  • Previous treatment with VELCADE
  • Any anti-neoplastic or experimental therapy within 3 weeks before the first dose of study drug.
  • Any treatment with nitrosoureas within 6 weeks before the first dose of study drug.
  • Treatment with Zevalin™ or Bexxar® within 10 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.
  • Radiation therapy within 3 weeks before the first dose of study drug.
  • Major surgery within 2 weeks before the first dose of study drug.
  • Peripheral neuropathy or neuropathic pain
  • History of allergic reaction attributable to compounds containing boron or mannitol
  • Known anaphylaxis or hypersensitivity to any component of rituximab
  • Diagnosed or treated for a selected malignancies other than NHL within 5 years.
  • Active systemic infection requiring treatment
  • Female subjects must not be pregnant, breast-feeding, or become pregnant during the course of the study.
  • Male subjects who do not agree to use an acceptable method of contraception for the duration of the study
  • Any serious medical or psychiatric illness likely to interfere with participation in this clinical study
  • Concurrent treatment with another investigational agent. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00085696

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United States, California
UCLA School of Medicine
Los Angeles, California, United States, 90095
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
United States, Georgia
Emory University Cancer Institute, Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Georgia Cancer Specialists
Marietta, Georgia, United States, 30060
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
Midwest Cancer Research Group
Skokie, Illinois, United States, 60077
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Missouri
Oncology/Henmatology Associates of Kansas City
Kansas City, Missouri, United States, 64111
United States, Ohio
Mid Ohio Oncology/Hematology Inc.
Columbus, Ohio, United States, 43213
United States, South Carolina
Charleston Cancer Center
Charleston, South Carolina, United States, 29406
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
United States, Utah
University of Utah, Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
United States, Virginia
FNVHO - US Oncology
Fairfax, Virginia, United States, 20031
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.

Layout table for additonal information Identifier: NCT00085696    
Other Study ID Numbers: M34103-061
First Posted: June 15, 2004    Key Record Dates
Last Update Posted: February 11, 2008
Last Verified: February 2008
Keywords provided by Millennium Pharmaceuticals, Inc.:
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Antineoplastic Agents, Immunological
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents