Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure

This study has been completed.
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00062621
First received: June 9, 2003
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to determine whether a combined bone marrow and kidney transplant will be effective in treating stage II or greater multiple myeloma and associated kidney failure. This study will determine whether transplant rejection and the need for immunosuppressive drugs are decreased with this combined transplant approach.


Condition Intervention Phase
Kidney Failure, Chronic
Multiple Myeloma
Procedure: Combined bone marrow and kidney transplant
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Remission status of multiple myeloma [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Renal allograft acceptance and ability to discontinue immunosuppressive therapy [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Graft vs. host disease (GVHD) [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Opportunistic infections [ Time Frame: Throughouto study ] [ Designated as safety issue: Yes ]
  • T-cell recovery and immune reconstitution [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 5
Study Start Date: June 2003
Study Completion Date: December 2006
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
Detailed Description:

In very limited human testing, a combined kidney and bone marrow transplant appears to be safe and effective in treating multiple myeloma and associated kidney failure. This study will evaluate this approach in 10 patients with kidney failure due to or in association with stage II or greater multiple myeloma. Treatment prior to transplant will include cyclophosphamide, ATGAM (a lymphocyte-specific immunosuppressant), local radiation to the thymus, and cyclosporine (an immunosuppressive drug).

An infusion of donor bone marrow and a kidney graft from a closely matched, related donor will be transplanted simultaneously. An additional infusion of donor white blood cells may be administered between day 45 and 74 after transplant in an effort to eliminate any remaining cancer cells. Patients will remain on cyclosporine for a defined period of time. The cyclosporine doses will be slowly decreased and stopped if graft rejection and graft-versus-host disease do not occur.

Each participant will be involved in the study for 3 years; this includes the intervention phase (time from initial screening at approximately 7 days before transplant through 100 days after the transplant) and continued follow-up visits for at least 2 years following the transplant.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • End-stage renal disease (ESRD) due to or in association with stage II or greater multiple myeloma
  • Participants in whom the development of ESRD is not due to the underlying myeloma will be included if they have evidence of active myeloma despite past treatment with standard therapies (e.g., prednisone, melphalan, high-dose radiation therapy with autologous stem cell transplantation)
  • On dialysis or have a creatinine clearance greater than 20 ml/min
  • HLA-matched or one of six HLA antigen-mismatched related donor

Exclusion Criteria:

  • Compromised pulmonary, cardiac, or liver function
  • Active infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00062621

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114-2696
Sponsors and Collaborators
Immune Tolerance Network (ITN)
Investigators
Principal Investigator: Thomas Spitzer, MD Massachussetts General Hospital
Principal Investigator: A. Benedict Cosimi, MD Massachussetts General Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00062621     History of Changes
Other Study ID Numbers: DAIT ITN008ST, NKDO1, DAIT NKDO1
Study First Received: June 9, 2003
Last Updated: February 1, 2013
Health Authority: United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Kidney Failure
Immune tolerance
Graft vs host disease
Kidney diseases
End Stage Renal Disease
Multiple Myeloma
Bone Marrow Transplant
Kidney Transplant
Renal Transplant
Tolerance
Chimerism
ESRD

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Multiple Myeloma
Neoplasms, Plasma Cell
Kidney Diseases
Urologic Diseases
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on July 24, 2014