VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

This study has been completed.
Information provided by:
Millennium Pharmaceuticals, Inc. Identifier:
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.

Condition Intervention Phase
Mantle Cell Lymphoma
Drug: VELCADE TM (bortezomib) for Injection
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Resource links provided by NLM:

Further study details as provided by Millennium Pharmaceuticals, Inc.:

Estimated Enrollment: 152
Study Start Date: June 2003
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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 identifier: NCT00063713

  Show 35 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
  More Information Identifier: NCT00063713     History of Changes
Obsolete Identifiers: NCT00084851
Other Study ID Numbers: M34103-053 
Study First Received: July 2, 2003
Last Updated: February 7, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses processed this record on April 27, 2016