Status:
COMPLETED
Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Millennium Pharmaceuticals, Inc.
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine if Velcade (also known as bortezomib) can help prevent graft versus host disease (GVHD) developing after transplantation. This is done by using a combination ...
Detailed Description
* In this study we are looking for the highest dose of Velcade that can be given to people safely when given with tacrolimus and methotrexate. Not everyone who participates in the study will receive t...
Eligibility Criteria
Inclusion
- Patients with hematologic malignancies including myelodysplastic syndrome (MDS), who are at a high risk of complications after myeloablative transplantation
- Patients have a donor (both related and unrelated) who are mismatched according to protocol criteria
- 18 years of age or older
- Performance status 0-2
- Life expectancy of \> 100 days
- Female subject is either post-menopausal or sterilized or willing to use an acceptable form of birth control
- Male subject agrees to use an acceptable form of birth control
Exclusion
- Evidence of HIV infection
- Total bilirubin \> 2.0mg/dl that is due to hepatocellular dysfunction
- Aspartate aminotransferase (AST) \> 90
- Known active hepatitis B or C
- Serum creatinine \> 2.0
- Greater than or equal to Grade 2 peripheral neuropathy within 21 days of enrollment
- Prior allogeneic stem cell transplant
- Patients with myeloproliferative disease (e.g. myelofibrosis, essential thrombocythemia, polycythemia vera, chronic myeloid leukemia)
- Myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV hear failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
- Hypersensitivity to Velcade, boron or mannitol
- Pregnant or breast feeding
- Patient has received other investigational drugs 14 days before enrollment
- Serious medical or psychiatric illness
- Another active solid tumor malignancy at the time of study entry
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00369226
Start Date
August 1 2006
End Date
September 1 2011
Last Update
July 25 2013
Active Locations (2)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115