Multiple Myeloma Clinical Trial
Official title:
Pilot Study of Umbilical Cord Blood Transplantation in Adult Patient With Advanced Hematopoietic Malignancies
This is a pilot study designed to evaluate the safety and feasibility of performing umbilical cord blood transplants in adults with high-risk hematopoietic malignancies. A novel myeloablative preparative regimen will be used. One, up to a maximum of three cord blood units will be administered to facilitate engraftment.
This study intends to demonstrate an engraftment rate of >80% at day 100
post-transplantation and a transplant related mortality rate of < or equal to 50%. A TRM of
>50% will be considered unacceptable. The present research will also:
- Evaluate the toxicity of busulfan, fludarabine, and etoposide as preparative therapy
prior to umbilical cord blood cell transplantation.
- Evaluate neutrophil and platelet recovery following UCB transplantation.
- Evaluate lineage-specific chimerism following transplantation and to assess the
contribution of each individual CB unit to post-transplantation hematopoiesis.
- Evaluate event free and overall survival.
- Evaluate the incidence, severity and timing of acute and chronic GVHD following UCB
transplantation.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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