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

Inclusion Criteria

• •Participants with end-stage renal failure due to or in association with multiple myeloma or systemic AL amyloidosis which hematopoietic cell transplantation is appropriate and a ≥ 50% five-year survival probability with transplantation is expected. This includes, but is not limited to:
• •Multiple myeloma (MM), ISS stage II or III in complete or very good partial remission
• •AL amyloidosis without significant cardiac disease
• •Males or females 18 - 65 years of age.
• •Participants must have an HLA-matched or one of six HLA A, B, or DR antigen-mismatched related donor, with high resolution molecular class I and II allele typing.
• •Men and women of reproductive potential must agree to use a reliable method of birth control during the treatment, and women should do so for a period of 2 years following the transplant.
• •Participants should be on dialysis or have a CrCl \<20 ml/min.
• •Patients should not have evidence of renal recovery of their renal failure over a 90 day period of therapy for their underlying malignancy or other blood disorder.
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• •Patients with a history of other malignancies excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix with a disease-free survival interval of \>2 years. Patients with the following malignancies must demonstrate a 5 year disease-free survival:
• •* Breast cancer with positive nodes
• •* Malignant melanoma (other than in situ)
• •* Colorectal cancer (other than Dukes Stage A or B1)
• •Patients with multiple myeloma must have received previous treatment with a bortezomib-based regimen.
• •Patients with AL amyloidosis must have received previous treatment with a bortezomib-based regimen and/or autologous stem cell transplantation
• •Patients with a history of malignant melanoma must be reviewed by an independent oncologist prior to enrollment.
• •Recipient ability to understand and provide informed consent.
• •HLA-matched or one of six HLA A, B, or DR antigen-mismatched related male or female donor 18-65 years of age.
• •ECOG performance status 0 or 1.
• •Excellent health per conventional pre-donor history (medical and psychosocial evaluation).
• •Acceptable laboratory parameters (hematology in normal or near-normal range; liver function \< 2 times the upper limit of normal and normal creatinine).
• •Compatible ABO blood group.
• •Negative donor lymphocyte crossmatch.
• •No positive testing for viral infection (HbsAg, HIV, HCV, HTLV-1).
• •Cardiac/Pulmonary evaluation within normal limits (CXR, EKG).
• •Donor ability to understand and provide informed consent.