Multiple MyelomaNCT00063791
A Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE
A study testing Bortezomib in people with Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 3 sites in United States.
Trial summary
The purpose of this study is to give patients who have had 4 or more prior lines of therapy for multiple myeloma access to VELCADE. The study is for patients who are not eligible for other clinical trials with VELCADE and for who VELCADE would otherwise not be available. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Bortezomib
- How many people
- Not given
- Where
- 3 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Major Criteria:
- Plasmacytomas on tissue biopsy
- Bone marrow plasmacytosis (> 30% plasma cells)
- Monoclonal IgG is > 3.5 g/dL or IgA is > 2.0 g/dL; kappa or lambda light chain excretion is > 1 g/day on a 24 hour urine sample.
- Minor criteria:
- Bone marrow plasmacytosis (10 to 30%)
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- Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria.
- Lytic bone lesions
- Other Eligibility Requirements:
- Patient is not eligible for Millennium Study M34101-039.
- Patient has received 4 or more lines of therapy for multiple myeloma and, in the investigator's opinion, currently needs therapy because of relapsed or progressive disease.
- Patient is of legal consenting age, as defined by local regulations.
- Patient is, in the investigator's opinion, willing and able to comply with the protocol requirements.
- Patient has given voluntary written informed consent before performance of any study-related procedure not part of normal medical care.
- Female patients must be either post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control throughout the study.
- Male patients must agree to use an acceptable method of birth control throughout the study.
- Patient has a Karnofsky performance status of greater than or equal to 60%.
- Patient meets pretreatment laboratory criteria at and within 14 to 21 days before Baseline (Day 1 of Cycle 1, before study drug administration).
Who cannot join
- Patient progressed while receiving VELCADE previously in a clinical trial.
- Patient has been treated in Millennium Study M34101-039.
- Patient received corticosteroids (> 10 mg/day prednisone or equivalent) within 1 week before enrollment in the study.
- Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment in the study.
- Patient received immunotherapy or antibody therapy within 4 weeks before enrollment.
- Patient had major surgery with 4 weeks before enrollment (kyphoplasty isn't considered major surgery).
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- Patient has a history of allergic reactions due to compounds containing boron or mannitol.
- Patient has peripheral neuropathy of Grade 2 or greater, as defined by the National Cancer Institute Common Toxicity Criteria (NCI CTC).
- Patient has a myocardial infarction within 6 months of enrollment or has New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias or electrocardiogram shows evidence of acute ischemia or active conduction system abnormalities.
- Patient has cardiac amyloidosis
- Patient has poorly controlled hypertension, diabetes mellitus, or other serious medical or psychiatric illness that could potentially interfere with the completion of treatment.
- Patient is known to be infected with human immunodeficiency virus (HIV positive).
- Patient is known to be hepatitis B positive or has active hepatitis C infection.
- Patient has an active systemic infection requiring treatment.
- Female patient is pregnant or breast-feeding. Confirmation that the patient is not pregnant is required. Pregnancy testing is not required for post-menopausal or surgically sterilized patients.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Henry Ford Health System
Detroit, Michigan, 48202
Michael Meshad, Oncology Center
Mobile, Alabama, 36608
Toledo Clinic
Toledo, Ohio, 43623
About this study
Official title: An Open-Labeled, Randomized Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE in Patients With Relapsed Multiple Myeloma Who Have Failed Four or More Lines of Therapy
The purpose of this study is to give patients who have had 4 or more prior lines of therapy for multiple myeloma access to VELCADE. The study is for patients who are not eligible for other clinical trials with VELCADE and for who VELCADE would otherwise not be available.
- Conditions
- Multiple Myeloma
- Being tested
- Bortezomib
- Keywords
- Relapsed or Refractory
- Medical subject headings
- Multiple Myeloma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00063791
- Sponsor's protocol ID
- M34102-052
- Status last verified
- Jul 2003
- First submitted
- 7 Jul 2003
- Last updated
- 14 Feb 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Labeled, Randomized Study to Assess Two Different Strategies of Combining Dexamethasone and VELCADE in Patients With Relapsed Multiple Myeloma Who Have Failed Four or More Lines of Therapy
- ClinicalTrials.gov ID
- NCT00063791
- Acronym / sponsor ID
- M34102-052
- Conditions
- Multiple Myeloma
- Keywords
- Relapsed or Refractory
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- First posted
- 8 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 give patients who have had 4 or more prior lines of therapy for multiple myeloma access to VELCADE. The study is for patients who are not eligible for other clinical trials with VELCADE and for who VELCADE would otherwise not be available.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Plasmacytomas on tissue biopsy
- Bone marrow plasmacytosis (> 30% plasma cells)
- Monoclonal IgG is > 3.5 g/dL or IgA is > 2.0 g/dL; kappa or lambda light chain excretion is > 1 g/day on a 24 hour urine sample.
- Bone marrow plasmacytosis (10 to 30%)
- Monoclonal immunoglobulin present but of lesser magnitude than given under major criteria.
Key exclusion criteria (15 listed)
- Patient progressed while receiving VELCADE previously in a clinical trial.
- Patient has been treated in Millennium Study M34101-039.
- Patient received corticosteroids (> 10 mg/day prednisone or equivalent) within 1 week before enrollment in the study.
- Patient received nitrosoureas within 6 weeks or any other chemotherapy within 3 weeks before enrollment in the study.
- Patient received immunotherapy or antibody therapy within 4 weeks before enrollment.
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 |
|---|---|---|
| Bortezomib | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2007.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bortezomib in people with Multiple Myeloma, run by Millennium Pharmaceuticals, Inc. at 3 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 18 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 14 Feb 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
Are results available for this study?
Results are not available in the source record.
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 14 Feb 2007.