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| Sponsor: | Millennium Pharmaceuticals, Inc. |
|---|---|
| Information provided by: | Millennium Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00063713 |
Purpose
The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.
| Condition | Intervention | Phase |
|---|---|---|
|
Mantle Cell Lymphoma |
Drug: VELCADE TM (bortezomib) for Injection |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma |
| Estimated Enrollment: | 152 |
| Study Start Date: | June 2003 |
| Primary Completion Date: | December 2005 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Exclusion Criteria
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| Alta Bates Medical Center | |
| Berkeley, California, United States, 94704 | |
| Stanford University | |
| Palo Alto, California, United States, 94304 | |
| Loma Linda Cancer Research Institute | |
| Loma Linda, California, United States, 92354 | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| UCLA School of Medicine | |
| Los Angeles, California, United States, 90095 | |
| United States, Colorado | |
| University of Colorado Cancer | |
| Denver, Colorado, United States, 80262 | |
| United States, District of Columbia | |
| Georgetown University Medical Center Lombardi Cancer Center | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| H. Lee Moffitt Cancer Center & Research Institute | |
| Tampa, Florida, United States, 33612 | |
| United States, Georgia | |
| The Emory Clinic | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| The Rush Cancer Center | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago Medical Center | |
| Chicago, Illinois, United States, 60637 | |
| United States, Indiana | |
| Indiana University Cancer Center | |
| Indianapolis, Indiana, United States, 46202 | |
| United States, Iowa | |
| University of Iowa Hospital Division | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Minnesota | |
| North Memorial Hospital | |
| Robbinsdale, Minnesota, United States, 55422 | |
| United States, Missouri | |
| Onc/Hem Associates of Kansas City | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Nebraska | |
| University of Nebraska Medical Center | |
| Omaha, Nebraska, United States, 68198 | |
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| University of Rochester Medical Center | |
| Rochester, New York, United States, 14642 | |
| New York Hospital Cornell Medical Center | |
| New York, New York, United States, 10021 | |
| Beth Israel Medical Center | |
| New York, New York, United States, 10003 | |
| St Lukes-Roosevelt Hospital | |
| New York, New York, United States, 10019 | |
| United States, North Carolina | |
| University of North Carolina | |
| Chapel Hill, North Carolina, United States, 27599 | |
| Wake Forest, University health Sciences/Comprehensive Cancer Center | |
| Winston-Salem, North Carolina, United States, 27157 | |
| United States, Oklahoma | |
| Cancer Care Associates | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| Cancer Care Associates | |
| Tulsa, Oklahoma, United States, 74136 | |
| United States, Oregon | |
| Oregon Health Science University | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19111 | |
| University of Pennsylvania Cancer Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Western Pennsylvania Hospital | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Tennessee | |
| Sarah Cannon Cancer Center | |
| Nashville, Tennessee, United States | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| United States, Wisconsin | |
| University Hospital-Madison Wisconsin | |
| Madison, Wisconsin, United States, 53792 | |
More Information
| Study ID Numbers: | M34103-053 |
| Study First Received: | July 2, 2003 |
| Last Updated: | February 7, 2008 |
| ClinicalTrials.gov Identifier: | NCT00063713 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Lymphoma, Mantle-Cell Bortezomib Enzyme Inhibitors |
Pharmacologic Actions Protease Inhibitors Lymphatic Diseases Neoplasms Therapeutic Uses Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma |