Mantle Cell LymphomaPhase 2NCT00063713
VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
A Phase 2 study testing VELCADE TM (bortezomib) for Injection in people with Mantle Cell Lymphoma, run by Millennium Pharmaceuticals, Inc. at 35 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle Cell Lymphoma
- What is being tested?
- VELCADE TM (bortezomib) for Injection
- Type of treatment
- Injection or infusion
- How many people
- 152 participants
- Where
- 35 sitesUnited States
- Study dates
- Jun 2003to Dec 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
The Emory Clinic
Atlanta, Georgia, 30322
Alta Bates Medical Center
Berkeley, California, 94704
University of Alabama
Birmingham, Alabama, 35294
University of North Carolina
Chapel Hill, North Carolina, 27599
The Rush Cancer Center
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Colorado Cancer
Denver, Colorado, 80262
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
MD Anderson Cancer Center
Houston, Texas, 77030
Indiana University Cancer Center
Indianapolis, Indiana, 46202
University of Iowa Hospital Division
Iowa City, Iowa, 52242
Onc/Hem Associates of Kansas City
Kansas City, Missouri, 64111
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Loma Linda Cancer Research Institute
Loma Linda, California, 92354
UCLA School of Medicine
Los Angeles, California, 90095
University Hospital-Madison Wisconsin
Madison, Wisconsin, 53792
Vanderbilt University
Nashville, Tennessee, 37232
Sarah Cannon Cancer Center
Nashville, Tennessee
Beth Israel Medical Center
New York, New York, 10003
St Lukes-Roosevelt Hospital
New York, New York, 10019
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
New York Hospital Cornell Medical Center
New York, New York, 10021
Cancer Care Associates
Oklahoma City, Oklahoma, 73112
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Stanford University
Palo Alto, California, 94304
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
Oregon Health Science University
Portland, Oregon, 97239
North Memorial Hospital
Robbinsdale, Minnesota, 55422
University of Rochester Medical Center
Rochester, New York, 14642
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612
Cancer Care Associates
Tulsa, Oklahoma, 74136
Georgetown University Medical Center Lombardi Cancer Center
Washington D.C., District of Columbia, 20007
Wake Forest, University health Sciences/Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157
About this study
Official title: 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.
Read the 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.
- Conditions
- Mantle Cell Lymphoma
- Being tested
- VELCADE TM (bortezomib) for Injection
- Medical subject headings
- Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VELCADE TM (bortezomib) for InjectionDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2003 (estimated)
- Study startJun 2003
- Primary completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 152 participants
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063713
- Sponsor's protocol ID
- M34103-053
- Status last verified
- Feb 2008
- First submitted
- 2 Jul 2003
- Last updated
- 11 Feb 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT00063713
- Acronym / sponsor ID
- M34103-053
- Conditions
- Mantle Cell Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2003
- Primary completion
- Dec 2005 (actual)
- First posted
- 4 Jul 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VELCADE TM (bortezomib) for Injection | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VELCADE TM (bortezomib) for Injection in people with Mantle Cell Lymphoma, run by Millennium Pharmaceuticals, Inc. at 35 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2008.