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VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Primary Purpose

Mantle Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
VELCADE TM (bortezomib) for Injection
Sponsored by
Millennium Pharmaceuticals, Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mantle Cell Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama
  • Alta Bates Medical Center
  • City of Hope Comprehensive Cancer Center
  • Loma Linda Cancer Research Institute
  • UCLA School of Medicine
  • Stanford University
  • University of Colorado Cancer
  • Georgetown University Medical Center Lombardi Cancer Center
  • H. Lee Moffitt Cancer Center & Research Institute
  • The Emory Clinic
  • The Rush Cancer Center
  • University of Chicago Medical Center
  • Indiana University Cancer Center
  • University of Iowa Hospital Division
  • North Memorial Hospital
  • Onc/Hem Associates of Kansas City
  • University of Nebraska Medical Center
  • Dartmouth-Hitchcock Medical Center
  • Beth Israel Medical Center
  • St Lukes-Roosevelt Hospital
  • Memorial Sloan Kettering Cancer Center
  • New York Hospital Cornell Medical Center
  • University of Rochester Medical Center
  • University of North Carolina
  • Wake Forest, University health Sciences/Comprehensive Cancer Center
  • Cancer Care Associates
  • Cancer Care Associates
  • Oregon Health Science University
  • University of Pennsylvania Cancer Center
  • Fox Chase Cancer Center
  • Western Pennsylvania Hospital
  • Vanderbilt University
  • Sarah Cannon Cancer Center
  • MD Anderson Cancer Center
  • University Hospital-Madison Wisconsin

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 2, 2003
Last Updated
February 7, 2008
Sponsor
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00063713
Brief Title
VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Official Title
A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Millennium Pharmaceuticals, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mantle Cell Lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
152 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
VELCADE TM (bortezomib) for Injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Alta Bates Medical Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
Loma Linda Cancer Research Institute
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
UCLA School of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University of Colorado Cancer
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
Georgetown University Medical Center Lombardi Cancer Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
H. Lee Moffitt Cancer Center & Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
The Emory Clinic
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
The Rush Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University of Iowa Hospital Division
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
North Memorial Hospital
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Onc/Hem Associates of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
St Lukes-Roosevelt Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
New York Hospital Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Wake Forest, University health Sciences/Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cancer Care Associates
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cancer Care Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Oregon Health Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Vanderbilt University
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Sarah Cannon Cancer Center
City
Nashville
State/Province
Tennessee
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University Hospital-Madison Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

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