VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

This study has been completed.
Sponsor:
Information provided by:
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00063713
First received: July 2, 2003
Last updated: February 7, 2008
Last verified: February 2008

July 2, 2003
February 7, 2008
June 2003
December 2005   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00063713 on ClinicalTrials.gov Archive Site
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VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
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.

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.

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Mantle Cell Lymphoma
Drug: VELCADE TM (bortezomib) for Injection
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
152
Not Provided
December 2005   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00063713
M34103-053
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Millennium Pharmaceuticals, Inc.
Not Provided
Not Provided
Millennium Pharmaceuticals, Inc.
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP