NCT00063713

CompletedPhase 2

VELCADE in Subjects With Relapsed or Refractory Mantle Cell ...

Millennium Pharmaceuticals, Inc.Source

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Other study identifiers

Sponsor study identifier

M34103-053

Study Type

interventional

Reported enrollment (type unavailable)

152

Locations

1 country

Sites

35

Timeline

Study Start

June 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2005

Actual (reported)

Study Completion

Not reported

Date not reported

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 152 participants
Study completion date: Not reported
Date not reported
Listed locations: 1 countries · 35 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
June 2003
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
July 2, 2003
Actual (reported)
First Posted
July 4, 2003
Actual (reported)
Primary Completion
December 2005
Actual (reported)

Last Updated: February 11, 2008
Status Verified: February 2008
Last Update Submitted: February 7, 2008

Conditions

Mantle Cell Lymphoma

Interventions

VELCADE TM (bortezomib) for InjectionDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

years of age or older
Confirmed diagnosis of mantle cell lymphoma

Sponsors & Collaborators

Millennium Pharmaceuticals, Inc.
Industrylead

Study Sites (35)

University of Alabama

Birmingham, Alabama, 35294, United States

Alta Bates Medical Center

Berkeley, California, 94704, United States

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Loma Linda Cancer Research Institute

Loma Linda, California, 92354, United States

UCLA School of Medicine

Los Angeles, California, 90095, United States

Stanford University

Palo Alto, California, 94304, United States

University of Colorado Cancer

Denver, Colorado, 80262, United States

MeSH Terms

Conditions

Lymphoma, Mantle-Cell

Interventions

BortezomibWW Domain-Containing Oxidoreductase

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Study Design

Study Type: interventional
Phase: phase 2
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

July 2, 2003

First Posted

July 4, 2003

Study Start

June 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2005

Actual (reported)

NCT00114738

EPOCH-R Chemotherapy Plus Bortezomib to Treat Mantle Cell Lymphoma

Phase 2Completed

NCT00022945

Safety and Efficacy Study of Iodine-131 Anti-B1 Antibody Plus CHOP For Untreated Mantle Cell Lymphoma

Phase 2Completed

NCT00581776

Phase II Study of VcR-CVAD With Rituximab Consolidation and Maintenance for Untreated Mantle Cell Lymphoma

Phase 2Completed

NCT00005780

Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma

Phase 2Completed

NCT01472562

Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma

Phase 2Completed

NCT00088205

Oral Enzastaurin in Participants With Relapsed Mantle Cell Lymphoma

Phase 2Completed

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Georgetown University Medical Center Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, 33612, United States

The Emory Clinic

Atlanta, Georgia, 30322, United States

The Rush Cancer Center

Chicago, Illinois, 60612, United States

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

University of Iowa Hospital Division

Iowa City, Iowa, 52242, United States

North Memorial Hospital

Robbinsdale, Minnesota, 55422, United States

Onc/Hem Associates of Kansas City

Kansas City, Missouri, 64111, United States

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Beth Israel Medical Center

New York, New York, 10003, United States

St Lukes-Roosevelt Hospital

New York, New York, 10019, United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10021, United States

New York Hospital Cornell Medical Center

New York, New York, 10021, United States

University of Rochester Medical Center

Rochester, New York, 14642, United States

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Wake Forest, University health Sciences/Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Cancer Care Associates

Oklahoma City, Oklahoma, 73112, United States

Cancer Care Associates

Tulsa, Oklahoma, 74136, United States

Oregon Health Science University

Portland, Oregon, 97239, United States

University of Pennsylvania Cancer Center

Philadelphia, Pennsylvania, 19104, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Western Pennsylvania Hospital

Pittsburgh, Pennsylvania, 15224, United States

Vanderbilt University

Nashville, Tennessee, 37232, United States

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, 77030, United States

University Hospital-Madison Wisconsin

Madison, Wisconsin, 53792, United States

Boronic Acids

Acids, Noncarboxylic

Acids

Inorganic Chemicals

Boron Compounds

Organic Chemicals

Pyrazines

Heterocyclic Compounds, 1-Ring

Heterocyclic Compounds

Short Chain Dehydrogenase-Reductases

NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases

Alcohol Oxidoreductases

Oxidoreductases

Enzymes

Enzymes and Coenzymes

Tumor Suppressor Proteins

Neoplasm Proteins

Proteins

Amino Acids, Peptides, and Proteins

Last Updated

February 11, 2008

Record last verified: 2008-02

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00063713
Data provider: ClinicalTrials.gov
Source updated: 2008-02-11
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:20:11 UTC

Locations

US(35)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Conditions

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (35)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations