Multiple Myeloma Clinical Trial
Official title:
Adjuvant Cellular Immunotherapy for High-Risk Hematologic Malignancy After Allogeneic Stem Cell Transplantation Using Low Intensity Conditioning
This research project will focus on whether it is safe and effective to rely on donor cells to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell transplant.
This research project will focus on whether it is safe and effective to rely on donor cells
to prevent relapse of leukemia, lymphoma, or other blood cancer after bone marrow stem cell
transplant (SCT). For many patients with these conditions, a bone marrow transplant can be
the only chance for cure. The standard type of bone marrow transplant involves giving very
high-doses of chemotherapy and radiation to kill all the cancer cells followed by an
infusion of bone marrow stem cells from a relative who is a bone marrow match. After the
transplant the patient takes anti-rejection drugs for many months to prevent the donor’s
immune cells from causing a severe reaction called Graft-versus-Host Disease (GVHD), which
can even be fatal. However, for some patients with certain types of high-risk cancer even
this intense treatment is not effective and the cancer relapses.
Is has been known for many years that some of the bone marrow cells from the donor can kill
cancer cells. Recently, it has been discovered that sometimes patients who relapse after a
bone marrow SCT can be cured by giving an infusion of donor white blood cells (called a
donor leukocyte infusion or DLI). By giving a DLI BEFORE a relapse happens, hopefully
relapse can be prevented.
The high doses of chemotherapy and radiation therapy given prior to a standard bone marrow
stem cell transplant can make a patient very sick and also increase the chance of getting
severe GVHD. In this research study we are going to rely mainly on the donor cells to kill
the cancer cells, and patients will receive dosages of chemotherapy that are lower than the
usual dosages. It is thought that this low intensity conditioning will make the transplant
safer without risking more relapses, however it is not know whether low intensity
conditioning is safer than standard conditioning.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training
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