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

Description

This pilot trial offers the unique opportunity for both the treatment of multiple myeloma or other hematologic disorder 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 other malignancies, 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 Start Date

February 2015

Estimated Completion Date

February 2021

Interventions

  • Drug: Tacrolimus
  • Procedure: Kidney transplant
  • Drug: Anti-thymocyte globulin
  • Drug: Bone marrow transplant from a related donor
  • Radiation: Total body irradiation 400 centigray (200 cGy X 2)

Specialties

  • Oncology: BMT/SCT
  • Nephrology: Chronic Dz/Renal Failure
  • Pharmacy: Chemotherapy/Oncology
  • Physician Assistant: Hematology/Oncology,Nephrology

MeSH Terms

  • Myelofibrosis
  • Paroxysmal
  • Primary Myelofibrosis
  • Tacrolimus

Study ID

Massachusetts General Hospital -- KdBMT-2

Status

Recruiting

Trial ID

NCT02158052

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

10

Sponsor

Massachusetts General Hospital

Inclusion Criteria

  • Participants with end-stage renal failure due to or in association with Durie Salmon Stage II or III multiple myeloma) or other hematologic disorder for which hematopoietic stem cell transplantation is appropriate. This includes, but is not limited to: acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma, multiple myeloma (MM), myelodysplastic syndrome (MDS), AL amyloidosis, Diamond Blackfan Anemia, myelofibrosis or other myeloproliferative disease, sickle cell anemia, and thalassemia.
  • Patients with myeloma must be in a very good partial remission or complete remission at the time of transplant. Patients with other hematologic malignancies must have treatment responsive disease at the time of transplant.
  • Males or females 18
  • 65 years of age.
  • Participants must have an HLA-matched or one of six HLA 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 creatinine clearance <20 ml/min.
  • Life expectancy >6 months.
  • 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 a history of malignant melanoma must be reviewed by an independent oncologist prior to enrollment.
  • Recipient ability to understand and provide informed consent

Exclusion Criteria

  • Evidence of active infection as defined by: a) clinical syndrome consistent with viral or bacterial infection (e.g., influenza, upper respiratory tract infection, UTI) or b) fever with a clinical site of infection identified, or c) microbiologically documented infection, including, but not limited to, bacteremia or septicemia.
  • Participation in other investigational drug use at the time of enrollment.
  • Contraindication to therapy with any one of the proposed agents (e.g., history of allergy to horse serum in ATG).
  • Serologic positivity to HIV or hepatitis C virus.
  • Women of childbearing age in whom adequate contraception cannot be maintained.
  • Aspartate aminotransferase (AST)/Alanine aminotransferase (ALT) > 3 x normal or bilirubin > 1.5 x normal (unless due to Gilbert's syndrome).
  • Pregnancy or uncontrolled serious medical illness not related to underlying myeloma.
  • Cardiac ejection fraction < 40% by echocardiogram.
  • Forced expiratory volume at one second (FEV1) < 50% predicted or corrected diffusing capacity carbon monoxide (DLCO) < 50% predicted.
  • Blood group A,B,O incompatibility in the host-vs-graft direction.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Thomas R Spitzer MD 617-724-1126 tspitzer@partners.org

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