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

This study has been completed.

Sponsors and Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network
Massachusetts General Hospital
Information provided by: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00062621
  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 I

Genetics Home Reference related topics:   aceruloplasminemia    hemophilia   

MedlinePlus related topics:   Kidney Failure    Kidney Transplantation    Multiple Myeloma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:   Combined HLA-Matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure

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

Arms Assigned Interventions
1: Experimental
Bone marrow and liver transplantation occurring at the same time
Procedure: Combined bone marrow and kidney transplant
Combined marrow and kidney transplant

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

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
National Institute of Allergy and Infectious Diseases (NIAID)
Immune Tolerance Network
Massachusetts General Hospital

Investigators
Principal Investigator:     Thomas Spitzer, MD     Massachussetts General Hospital    
Principal Investigator:     A. Benedict Cosimi, MD     Massachussetts General Hospital    
  More Information

Click here for the Immune Tolerance Network Web site  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   ITN008ST, NKDO1, DAIT NKDO1
First Received:   June 9, 2003
Last Updated:   May 8, 2008
ClinicalTrials.gov Identifier:   NCT00062621
Health Authority:   United States: Federal Government

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

Study placed in the following topic categories:
Renal Insufficiency
Immunoproliferative Disorders
Graft versus host disease
Hematologic Diseases
Blood Coagulation Disorders
Kidney Failure, Chronic
Vascular Diseases
Paraproteinemias
Hemostatic Disorders
Homologous wasting disease
Multiple Myeloma
Hemorrhagic Disorders
Multiple myeloma
Urologic Diseases
Renal Insufficiency, Chronic
Graft vs Host Disease
Kidney Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell
Kidney Failure

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Immune System Diseases
Blood Protein Disorders
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 04, 2008




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