At a glance
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Combined HLA-Matched Bone Marrow and Kidney Transplantation for Multiple Myeloma or Other Hematologic Disorders With End Stage Renal Disease
In Brief
A clinical study evaluating Tacrolimus, Equine Anti-thymocyte globulin, and 3 other interventions for Multiple Myeloma and Amyloidosis. Completed, enrolled 2 participants across 1 site.
Detailed Summary
This pilot trial offers the unique opportunity for both the treatment of multiple myeloma or systemic AL amyloidosis for which hematopoietic stem cell transplantation would be ordinarily indicated and the reversal of end-stage renal failure, while avoiding the risks associated with long-term standard anti-rejection therapy used in renal transplantation. The primary objectives of this study are to assess renal allograft tolerance (that is, the acceptance of the kidney without the need for anti-rejection therapy), assess anti-tumor response rates in multiple myeloma and AL amyloidosis, and assess complication rates for genetically (HLA) matched related donor combined bone marrow and kidney transplantation using a low dose total body irradiation based preparative regimen.
Study Details
Timeline
Interventions
Tacrolimus starting on Day -1
20 mg/kg IV on Days -3, -1, +1, +3
On Day 0 the renal transplant is performed according to standard surgical techniques.
Donor bone marrow (\> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed.
On transplant day -1