Myelodysplastic SyndromePhase 1NCT00271804
Study of Velcade and Thalidomide in Patients With Myelodysplasia
A Phase 1 study testing bortezomib in people with Myelodysplastic Syndrome, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The purpose of this study is to find out what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelodysplastic Syndrome
- What is being tested?
- bortezomib
- How many people
- 28 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2005to Apr 2007
- Phase
- Phase 1
- 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
- Myelodysplastic syndrome with a IPSS score of 0.5 or greater
- May have had prior chemo/radiotherapy for another malignancy or myelodysplasia
- ECOG performance status of 0-2
- Life expectancy greater than 3 months
- Total bilirubin </+ 2xULN
- ALT and AST </+ 3xULN
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- Calculated creatinine clearance > 30 ml/min
- Use of appropriate method of contraception during the study
- ANC > 0.5 x 10(9)
- Platelet count > 30 x 10(9)
- Consideration of treatment with 5 azacytidine is encouraged by not required
Who cannot join
- Ejection fraction < 40%
- myocardial infarction within 6 months of enrollment of New York Heart Association Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Women who are pregnant or breast-feeding
- Major surgery within 4 weeks prior to enrollment
- >/= grade 2 peripheral neuropathy within 14 days prior to enrollment
- Uncontrolled intercurrent illness
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- Serious medical or psychiatric illness that could potentially interfere with the completion of treatment
- Hypersensitivity to bortezomib, boron, or mannitol
- Received an investigational drug within 14 days of enrollment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: Phase I Dose Escalation Trial of Bortezomib in Combination With Thalidomide in Patients With Myelodysplasia
The purpose of this study is to find out what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia.
Read the detailed description
Initial studies using Velcade in myelodysplasia with early results demonstrating that 35% had a partial response and 25% had stable disease. The combination of Velcade and thalidomide has been studied in patients with multiple myeloma, but not in patients with myelodysplasia. The CRR in the MM patients was 22%, with a good safety profile.
This is a phase 1, prospective, open-label, dose escalation study to evaluate the DLT and MTD of velcade with given in combination with thalidomide in patients with myelodysplasia. Treatment will be given as an outpatient. Patients will receive 4 days of Velcade (days 1, 4, 8, 11) and 21 days of thalidomide 50 mg/day for each 21 day cycle. There will be 3 cohorts of 3-6 patients each, plus 10 additional patients. The tree dose levels ill be 0.7, 1.0 and 1.3 mg/m2. Patients may continue to be treated up to 6 cycles. Cycles 2-6 will start within 2 weeks of completion of the previous cycle. Disease response will be evaluated after cycle 3 and 6.
- Conditions
- Myelodysplastic Syndrome
- Being tested
- bortezomib
- Keywords
- Myelodysplastic syndrome, Myelodysplasia, MDS, Velcade, Thalidomide, Bortezomib
- Medical subject headings
- Myelodysplastic Syndromes, Anemia, Refractory, with Excess of Blasts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bortezomibDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.
Secondary outcomes (3)
Assess efficacy in terms of the number of patients attaining a 50% reduction in blast percentage, or 50% reduction in number of red blood cell and/or platelet transfusions.
Determine the toxicity profile of bortezomib when used in combination with thalidomide for patients with myelodysplasia.
Determine the relationship between NF-kB expression and clinical response to bortezomib and thalidomide.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startJun 2005
- Study completionApr 2007
Why it stopped: New study with lenalidomide pending
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myelodysplastic SyndromeStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center
- Investigators
- Karen Ballen, M, Principal investigator, Massachusetts General Hospital, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271804
- Sponsor's protocol ID
- 04-381
- Status last verified
- Mar 2008
- First submitted
- 30 Dec 2005
- Last updated
- 13 Mar 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Dose Escalation Trial of Bortezomib in Combination With Thalidomide in Patients With Myelodysplasia
- ClinicalTrials.gov ID
- NCT00271804
- Acronym / sponsor ID
- 04-381
- Conditions
- Myelodysplastic Syndrome
- Keywords
- Myelodysplastic syndrome, Myelodysplasia, MDS, Velcade, Thalidomide, Bortezomib
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: New study with lenalidomide pending
- Enrolment
- 28 participants
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center
- Study start
- Jun 2005
- Study completion
- Apr 2007
- First posted
- 4 Jan 2006 (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 what the maximal tolerated dose of Velcade can be given with thalidomide in patients with myelodysplasia.
Detailed description
Initial studies using Velcade in myelodysplasia with early results demonstrating that 35% had a partial response and 25% had stable disease. The combination of Velcade and thalidomide has been studied in patients with multiple myeloma, but not in patients with myelodysplasia. The CRR in the MM patients was 22%, with a good safety profile.
This is a phase 1, prospective, open-label, dose escalation study to evaluate the DLT and MTD of velcade with given in combination with thalidomide in patients with myelodysplasia. Treatment will be given as an outpatient. Patients will receive 4 days of Velcade (days 1, 4, 8, 11) and 21 days of thalidomide 50 mg/day for each 21 day cycle. There will be 3 cohorts of 3-6 patients each, plus 10 additional patients. The tree dose levels ill be 0.7, 1.0 and 1.3 mg/m2. Patients may continue to be treated up to 6 cycles. Cycles 2-6 will start within 2 weeks of completion of the previous cycle. Disease response will be evaluated after cycle 3 and 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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 (11 listed)
- Myelodysplastic syndrome with a IPSS score of 0.5 or greater
- May have had prior chemo/radiotherapy for another malignancy or myelodysplasia
- ECOG performance status of 0-2
- Life expectancy greater than 3 months
- Total bilirubin </+ 2xULN
Key exclusion criteria (9 listed)
- Ejection fraction < 40%
- myocardial infarction within 6 months of enrollment of New York Heart Association Class III or IV heart failure, uncontrolled angina, uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Women who are pregnant or breast-feeding
- Major surgery within 4 weeks prior to enrollment
- >/= grade 2 peripheral neuropathy within 14 days prior to 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
The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.
3 secondary outcomes
Assess efficacy in terms of the number of patients attaining a 50% reduction in blast percentage, or 50% reduction in number of red blood cell and/or platelet transfusions.
Determine the toxicity profile of bortezomib when used in combination with thalidomide for patients with myelodysplasia.
Determine the relationship between NF-kB expression and clinical response to bortezomib and thalidomide.
Results and safety
The study was stopped early (reason given: New study with lenalidomide pending). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 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.
Karen Ballen, M principal investigator
Massachusetts General Hospital, Harvard University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing bortezomib in people with Myelodysplastic Syndrome, run by Massachusetts General Hospital 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 11 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Mar 2008. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: New study with lenalidomide pending). 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.
What does the primary outcome measure?
The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.. It is what the study was designed to measure, not a finding.
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 13 Mar 2008.