Back to resultsStudy of Velcade and Thalidomide in Patients With Myelodysplasia
Primary Purpose
Myelodysplastic Syndrome
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic Syndrome focused on measuring Myelodysplastic syndrome, Myelodysplasia, MDS, Velcade, Thalidomide, Bortezomib
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Sites / Locations
- Massachusetts General Hospital
- Beth Israel Deaconess Medical Center
- Dana Farber Cancer Institute
Outcomes
Primary Outcome Measures
The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00271804
First Posted
December 30, 2005
Last Updated
March 7, 2008
Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00271804
Brief Title
Study of Velcade and Thalidomide in Patients With Myelodysplasia
Official Title
Phase I Dose Escalation Trial of Bortezomib in Combination With Thalidomide in Patients With Myelodysplasia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Terminated
Why Stopped
New study with lenalidomide pending
Study Start Date
June 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Beth Israel Deaconess Medical Center
4. Oversight
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic Syndrome
Keywords
Myelodysplastic syndrome, Myelodysplasia, MDS, Velcade, Thalidomide, Bortezomib
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
bortezomib
Primary Outcome Measure Information:
Title
The primary objective is to establish the maximally tolerated dose of bortezomib that can be administered with thalidomide in patient with myelodysplasia.
Secondary Outcome Measure Information:
Title
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.
Title
Determine the toxicity profile of bortezomib when used in combination with thalidomide for patients with myelodysplasia.
Title
Determine the relationship between NF-kB expression and clinical response to bortezomib and thalidomide.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Ballen, M
Organizational Affiliation
Massachusetts General Hospital, Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Velcade and Thalidomide in Patients With Myelodysplasia
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