Multiple Myeloma Clinical Trial
Official title:
Intentional Rejection of the Donor Graft Using Recipient Leukocyte Infusion(s) Following Nonmyeloablative Allogeneic Stem Cell Transplantation
One risk of a stem cell transplant is that the donated stem cells do not grow in the recipient. This is called graft rejection. Previous laboratory research has suggested that the reaction between the recipient's cells and the donor's cells that causes graft rejection is associated with an anti-cancer effect. In this research study the investigators will give participants some of their own white blood cells after their transplant. This is called a recipient leukocyte infusion (RLI). This is done to cause the participant's immune system to react against the donor's cells and reject the transplant. The purpose of this research study is to learn if the graft rejection has an anti-cancer effect.
- The first 10 participants (Group 1) will receive a conditioning regimen of total body
irradiation (TBI) before the stem cell transplant. It is possible this conditioning
regimen may suppress the immune system enough. This can cause the stem cell transplant
to be rejected to quickly. It is necessary for the transplant to begin to grow before
it is rejected. If the participants in Group 1 reject their stem cell transplant too
quickly, the next group of 10 participants (Group 2) will receive a medication called
fludarabine for three days before the TBI. The purpose of adding fludarabine is to
suppress the immune system enough to allow the transplant to initially grow. An
additional RLI may be given 2 weeks after the first RLI.
- Before the conditioning regimen (either TBI or fludarabine), participants will undergo
a procedure to collect their white blood cells called leukapheresis. The white blood
cells collected will then be frozen and stored and given to the participant as an RLI
on Day 38 after their stem cell transplant.
- Participants will receive their donor's stem cells about 4-6 hours after TBI. They will
also receive the following medications to prevent GVHD: Cyclosporine orally until about
day 35 and Mycophenolate Mofetil (MMF) orally until 21 days after the stem cell
transplant.
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Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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