Bortezomib Plus Tacrolimus and Methotrexate to Prevent Graft Versus Host Disease (GVHD) After Mismatched Allogeneic Non-Myeloablative Blood Stem Cell Transplantation

Completed · Phase 1/Phase 2

Conditions studied: Hematologic Malignancies

In brief

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 of three immune suppressive medications: Velcade, tacrolimus and methotrexate. Stem cell transplantation is one of the options for patients with cancer of the blood or blood forming organs. Recently, allogeneic stem cell transplants have been performed using lower doses of chemotherapy and radiotherapy: non-myeloablative or "mini" transplants. GVHD is a significant problem that may occur even after "mini" transplantations. Information from other research studies, suggests that Velcade may help to reduce the risk of developing GVHD when given early after transplantation.

Key facts

Study ID: NCT00369226
Run by: Dana-Farber Cancer Institute
People needed: 45
Starts: 2006-08-01
Expected to finish: 2011-09-01
Last updated by the study team: 2013-07-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Brigham and Women's Hospital — Boston, Massachusetts, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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