Multiple Myeloma Clinical Trial
Official title:
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent GVHD After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
The purpose of this study is to compare the effects (good and bad) of the medication basiliximab in combination with cyclosporine (investigational therapy) for the prevention of a complication of bone marrow transplantation known as graft-versus-host disease (GVHD). GVHD is a complication in which the cells of the transplanted bone marrow react against organs and tissues.
This study is for patients with a blood condition or myelodysplasia (bone marrow disease)
which has either not responded to treatment or is not treatable by conventional/routine
medical treatments. Bone marrow transplantation is a medical treatment that involves giving
high doses of chemotherapy followed by the transplantation of the blood-forming and immune
cells from a relative or from a "matched" unrelated person through the National Marrow Donor
Program, in an attempt to cure disease in the recipient (the person receiving the donated
cells). Nonmyeloablative (bone-marrow preservation) bone marrow transplantation is a
relatively new technique in which lower than usual doses of chemotherapy are given before
transplantation, in hopes of reducing adverse side effects of the chemotherapy in transplant
patients. Nonmyeloablative bone marrow transplantation has several advantages which doctors
have determined are beneficial for this condition.
This research is being done because the complication of graft-versus-host disease can be bad
for a person and there is no completely safe and effective way to prevent this complication.
We know that cyclosporine helps but would like to know if the addition of basiliximab, given
with cyclosporine, will decrease the incidence and/or severity of graft-versus-host disease
after a transplant known as nonmyeloablative or "mini" transplant.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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