VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

February 7, 2008 updated by: Millennium Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment

152

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Medical Center
      • Duarte, California, United States, 91010-3000
        • City of Hope Comprehensive Cancer Center
      • Loma Linda, California, United States, 92354
        • Loma Linda Cancer Research Institute
      • Los Angeles, California, United States, 90095
        • UCLA School of Medicine
      • Palo Alto, California, United States, 94304
        • Stanford University
    • Colorado
      • Denver, Colorado, United States, 80262
        • University of Colorado Cancer
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University Medical Center Lombardi Cancer Center
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center & Research Institute
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • The Emory Clinic
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60612
        • The Rush Cancer Center
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospital Division
    • Minnesota
      • Robbinsdale, Minnesota, United States, 55422
        • North Memorial Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Onc/Hem Associates of Kansas City
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth-Hitchcock Medical Center
    • New York
      • New York, New York, United States, 10003
        • Beth Israel Medical Center
      • New York, New York, United States, 10021
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10019
        • St Lukes-Roosevelt Hospital
      • New York, New York, United States, 10021
        • New York Hospital Cornell Medical Center
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest, University health Sciences/Comprehensive Cancer Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Cancer Care Associates
      • Tulsa, Oklahoma, United States, 74136
        • Cancer Care Associates
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19111
        • Fox Chase Cancer Center
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Cancer Center
      • Pittsburgh, Pennsylvania, United States, 15224
        • Western Pennsylvania Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
      • Nashville, Tennessee, United States
        • Sarah Cannon Cancer Center
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Hospital-Madison Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Millennium Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

December 1, 2005

Study Registration Dates

First Submitted

July 2, 2003

First Submitted That Met QC Criteria

July 3, 2003

First Posted (Estimate)

July 4, 2003

Study Record Updates

Last Update Posted (Estimate)

February 11, 2008

Last Update Submitted That Met QC Criteria

February 7, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M34103-053

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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