Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure - Tabular View

Tracking Information

First Received Date ^ICMJE

June 9, 2003

Last Updated Date

May 13, 2009

Start Date ^ICMJE

June 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Remission status of multiple myeloma
Renal allograft acceptance and ability to discontinue immunosuppressive therapy

Change History

Complete list of historical versions of study NCT00062621 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Graft vs. host disease (GVHD)
opportunistic infections
T cell recovery and immune reconstitution

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Combined HLA-Matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure

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.

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 Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Kidney Failure, Chronic
Multiple Myeloma

Intervention ^ICMJE

Procedure: Combined bone marrow and kidney transplant

Study Arms / Comparison Groups

Experimental: Bone marrow and liver transplantation occurring at the same time

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2006

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00062621

Responsible Party

Study ID Numbers ^ICMJE

DAIT ITN008ST, NKDO1, DAIT NKDO1

Study Sponsor ^ICMJE

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborators ^ICMJE

Immune Tolerance Network
Massachusetts General Hospital

Investigators ^ICMJE

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

Information Provided By

National Institute of Allergy and Infectious Diseases (NIAID)

Verification Date

November 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP