Multiple Myeloma Clinical Trial
Official title:
Phase II Study of Sequential Unrelated Cord Blood Transplantation Using Tacrolimus and Sirolimus as Graft Versus Host Disease Prophylaxis
The purpose of this study is to measure the effectiveness of 2 drugs, tacrolimus and sirolimus, in preventing graft versus host disease (GVHD) after treatment with chemotherapy followed by donor cord blood transplantation.
- The chemotherapy portion of the study involves the intravenous administration of
fludarabine, for six days (Days 8, 7, 6, 5,4, and 3) before transplant, melphalan, for
one day (Day 2) before transplant. Antithymocyte globulin, or thymoglobulin, will be
given IV daily for 4 days (days 7, 5, 3, and 1 before transplant). This drug also helps
to suppress the immune system, allowing the cord blood cells to grow and reproduce.
- Immunosuppression therapy consists of the drugs tacrolimus and sirolimus. The patient
will receive these 3 days before the transplant and every day for 3-6 months after
transplant. After the first 100 days post transplant, the doses of tacrolimus and
sirolimus will begin to be reduced with the goal of having the patient off both drugs
by 6-9 months after transplant.
- After completion of conditioning therapy described above, the patient will receive 2
cord blood units 1-6 hours apart. To help with engraftment, the patient will also
receive G-CSF starting on day five after transplant, until the patients white blood
cells recover.
- Follow-up visits will continue every 6 months after the last treatment dose and will
last up to 2 years.
- Blood tests will be drawn frequently to test whether the donor's immune cells have
engrafted as well as to test the levels of Tacrolimus and Sirolimus.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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