VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
This study has been completed.
Information provided by:
Millennium Pharmaceuticals, Inc.
First received: July 2, 2003
Last updated: February 7, 2008
Last verified: February 2008
The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.
Mantle Cell Lymphoma
Drug: VELCADE TM (bortezomib) for Injection
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
| Estimated Enrollment:
| Study Start Date:
| 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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00063713
Millennium Pharmaceuticals, Inc.
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 2, 2003
||February 7, 2008
||United States: Food and Drug Administration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on July 24, 2014
Neoplasms by Histologic Type
Immune System Diseases
Molecular Mechanisms of Pharmacological Action