Multiple Myeloma Clinical Trial
Official title:
MT2008-15: Transplantation of Unrelated Donor Umbilical Cord Blood in Patients With Hematological Malignancies Using a Nonmyeloablative Preparative Regimen and Priming With Complement 3a Fragment (C3a)
RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor
umbilical cord blood transplant helps stop the growth of cancer cells. It may also stop the
patient's immune system from rejecting the donor's stem cells. The donated stem cells may
replace the patient's immune cells and help destroy any remaining cancer cells
(graft-versus-tumor effect).
PURPOSE: This phase I trial is studying the safety of donor umbilical cord blood transplant
after fludarabine phosphate, cyclophosphamide, and total-body irradiation in treating
patients with high-risk hematologic cancer (now closed).
The Phase II part of this trial is studying whether priming one of two UCB units with C3a
facilitates engraftment of the treated unit.
OUTLINE:
- Nonmyeloablative preparative regimen: Patients receive fludarabine phosphate IV over 1
hour on days -6 to -2 and cyclophosphamide IV over 2 hours on day -6. Patients then
undergo total-body irradiation on day -1. Some patients also receive anti-thymocyte
globulin IV every 12 hours on days -6, -5, and -4.
- Umbilical cord blood (UCB) transplantation: Patients undergo unmanipulated UCB
transplantation followed by complement 3a fragment primed UCB transplantation on day 0.
Treatment for graft-vs-host disease prophylaxis is also given.
After completion of study therapy, patients are followed up periodically for up to 2 years.
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