drugset / Trial / NCT02158052

Combined Bone Marrow and Renal Transplantation for Hematologic Disorders With End Stage Renal Disease

NCT02158052

Completed 2 enrolled Massachusetts General Hospital
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2015-02
Primary completion
2021-06-22
Completion
2021-06-22

Drugs

EvaluationDrugModalityDoseRoute
Background ANTILYMPHOCYTE IMMUNOGLOBULIN (HORSE) Protein / enzyme biologic 20 mg/kg Intravenous
Background Tacrolimus Small molecule