Myelodysplastic Syndrome Clinical Trial
Bortezomib-based GVHD Prophylaxis After Allogeneic Transplant for Patients Without Matched Related Donors
Summary
A common problem after stem cell transplant is graft-versus-host-disease (GVHD). GVHD is a complication of transplantation where the donor graft attacks and damages some of your tissues. After stem cell transplant, all patients receive prophylactic medications against GVHD.
In this research study, we are studying the safety and effectiveness of a bortezomib based GVHD prophylaxic drug combination in participants after myeloablative allogeneic stem call transplantation from a matched unrelated donor, mismatched related or unrelated donor.
Full Description
Before your transplant you will receive conditioning therapy with fludarabine and busulfan given 7, 6, 5, and 4 days before your transplant. On day 0, you will receive selected blood cells taken from your sibling or unrelated donor.
You will receive 3 drugs for your GVHD prophylaxis:
Tacrolimus will be started 3 days before your transplant. It will be given intravenously and later by mouth. You will continue to take tacrolimus for 3 to 6 months after transplant.
Methotrexate will be given intravenously 1, 3, 6 and 11 days after your transplant.
Bortezomib will be given intravenously 1, 4, and 7 days after your transplant. On days 1, 4, 7, 30 and 3, 6 and 12 months after your transplant you will have a physical exam, blood work, and be asked to complete a questionnaire.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed advanced and/or aggressive hematologic malignancy (including myelodysplastic syndrome) that is unlikely to be cured by alternative therapies
HLA-Matched unrelated donor; or 1-locus HLA-mismatched related or unrelated donor
ECOG performance status 0-2
Adequate organ function
Able to understand and willing to sign a written informed consent document
Agrees to practice adequate contraception per study requirements
Exclusion Criteria:
Pregnant or breastfeeding
Recipient of prior allogeneic or autologous stem cell transplantation
Prior abdominal radiation therapy
HIV-positive on combination antiretroviral therapy
Seropositive for hepatitis B or C
Allergies to bortezomib, boron, or mannitol
Myocardial infarction within last 6 months, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias
Uncontrolled bacterial, viral or fungal infections
Seizures or history of seizures
History of another non-hematologic malignancy unless disease-free for at least 5 years
Uncontrolled intercurrent illness
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There is 1 Location for this study
Boston Massachusetts, 02215, United States
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