Graft-versus-Host Disease Clinical Trial
Official title:
Phase II Trial of VELCADE® (Bortezomib) for Steroid Refractory Acute GVHD
The purpose of this research study is to test the safety and effectiveness of VELCADE® in the treatment of acute graft-versus-host disease (GVHD) that has not responded to steroids or has worsened when the steroid dose was decreased. VELCADE® is a drug that inhibits certain immune reactions that happen when lymphocytes encounter foreign substances. We are doing this research to determine if VELCADE® may be useful in treating GVHD.
Graft-versus-host disease (GVHD) is a serious complication after bone marrow transplantation
from another donor. GVHD is caused by certain cells called lymphocytes. Normally these cells
make immune reactions that help protect the body from foreign substances that cause
infection. Here, these cells attack the normal tissues of the body as if they were foreign
substances. This interferes with the normal function of vital organs and results in their
damage. In GVHD these cells attack the skin, liver and bowel. GVHD also increases the
chances of infection.
VELCADE® is a drug that inhibits certain immune reactions that happen when lymphocytes
encounter foreign substances. We are doing this research to determine if VELCADE® may be
useful in treating GVHD.
VELCADE® is approved by the Food and Drug Administration (FDA) for the treatment of multiple
myeloma in patients who have received at least two prior therapies and have demonstrated
disease progression on their last therapy. Its effectiveness is also being tested in other
cancers. The dose of the drug being used in this research study is the same as what is used
for the treatment of multiple myeloma. It has not been approved by the FDA for use in GVHD.
Therefore, using VELCADE® for GVHD is experimental in this research study.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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|---|---|---|---|
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