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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00062621
Recruitment Status : Completed
First Posted : June 12, 2003
Last Update Posted : February 5, 2013
Sponsor:
Collaborator:
Immune Tolerance Network (ITN)
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Kidney Failure, Chronic Multiple Myeloma Procedure: Combined bone marrow and kidney transplant Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure
Study Start Date : June 2003
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Remission status of multiple myeloma [ Time Frame: Throughout study ]
  2. Renal allograft acceptance and ability to discontinue immunosuppressive therapy [ Time Frame: Throughout study ]

Secondary Outcome Measures :
  1. Graft vs. host disease (GVHD) [ Time Frame: Throughout study ]
  2. Opportunistic infections [ Time Frame: Throughouto study ]
  3. T-cell recovery and immune reconstitution [ Time Frame: Throughout study ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062621


Locations
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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 (ITN)
Investigators
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Principal Investigator: Thomas Spitzer, MD Massachussetts General Hospital
Principal Investigator: A. Benedict Cosimi, MD Massachussetts General Hospital
More Information
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Additional Information:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00062621    
Other Study ID Numbers: DAIT ITN008ST
NKDO1
DAIT NKDO1
First Posted: June 12, 2003    Key Record Dates
Last Update Posted: February 5, 2013
Last Verified: February 2013
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
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Renal Insufficiency
Kidney Failure, Chronic
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
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic