VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma - Tabular View

Tracking Information
First Received Date ^ICMJE	July 2, 2003
Last Updated Date	February 7, 2008
Start Date ^ICMJE	June 2003
Primary Completion Date	December 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00063713 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Official Title ^ICMJE	A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Brief Summary	The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.
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 Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Condition ^ICMJE	Mantle Cell Lymphoma
Intervention ^ICMJE	Drug: VELCADE TM (bortezomib) for Injection
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	152
Completion Date
Primary Completion Date	December 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00063713
Responsible Party
Study ID Numbers ^ICMJE	M34103-053
Study Sponsor ^ICMJE	Millennium Pharmaceuticals, Inc.
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Millennium Pharmaceuticals, Inc.
Verification Date	February 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP