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

Phase 1

Completed

• Conditions: Kidney Failure, Chronic; Multiple Myeloma

• Registration Number: NCT00062621
• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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 Timeline

• Study Start: 2003-06
• Study First Submitted: 2003-06-09
• Study First Submitted QC: 2003-06-11
• Study First Posted: 2003-06-12
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-01
• Last Update Posted: 2013-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Remission status of multiple myeloma	Throughout study
Renal allograft acceptance and ability to discontinue immunosuppressive therapy	Throughout study

Secondary Outcome Measures

Name	Time	Method
Graft vs. host disease (GVHD)	Throughout study
Opportunistic infections	Throughouto study
T-cell recovery and immune reconstitution	Throughout study

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States