Multiple Myeloma Clinical Trial
Official title:
Pilot Study of Reduced-Intensity Umbilical Cord Blood Transplantation in Adult Patients Wtih Advanced Hematopoietic Malignancies
This is a pilot study designed to evaluate the safety and feasibility of performing umbilical cord blood transplants in older adults or younger infirm patients with high-risk hematopoeitic malignancies. A novel reduced-intensity preparative regimen for umbilical cord blood transplantation will be used. One to a maximum of three cord blood units, depending on cell count, will be administered to facilitate engraftment. Ten patients will be enrolled with an expected accrual rate of 3-4 patients per year and with a goal of completing accrual within 2-3 years.
Primary Objective:
- To assess the feasibility of performing umbilical cord blood transplants in older
adults or younger infirm patients using a reduced-intensity preparative regimen.
Feasibility of the procedure is defined as an engraftment rate of >80% at Day 180
post-transplantation and a transplant related mortality (TRM) of <50% at Day 100. A TRM
of >50% will be considered unacceptable.
Secondary objectives:
- To describe the time to neutrophil and platelet recovery following mini-UCB
transplantation.
- To assess lineage-specific chimerism following transplantation and to describe the
contribution of each individual CB unit to post-transplantation hematopoeisis.
- To describe disease-specific, event-free and overall survival rates at 180 and 360
days.
- To describe the incidence, severity, and timing of acute and chronic GVHD following
reduced-intensity UCB transplantation.
- To evaluate T-cell, B-cell, and NK cell recovery following reduced-intensity UCB
transplantation.
;
Observational Model: Case-Only, Time Perspective: Prospective
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