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

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00062621
• Other study ID #: DAIT ITN008ST
• Secondary ID: NKDO1DAIT NKDO1
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2003
• Last updated: February 1, 2013
• Start date: June 2003
• Est. completion date: December 2006

Study information

• Verified date: February 2013
• Source: National Institute of Allergy and Infectious Diseases (NIAID)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Renal Insufficiency

Intervention

Procedure:
• Combined bone marrow and kidney transplant

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
National Institute of Allergy and Infectious Diseases (NIAID)	Immune Tolerance Network (ITN)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission status of multiple myeloma		Throughout study	Yes
Primary	Renal allograft acceptance and ability to discontinue immunosuppressive therapy		Throughout study	Yes
Secondary	Graft vs. host disease (GVHD)		Throughout study	Yes
Secondary	Opportunistic infections		Throughouto study	Yes
Secondary	T-cell recovery and immune reconstitution		Throughout study	Yes

External Links

•   Click here for the Immune Tolerance Network Web site
•   National Institute of Allergy and Infectious Diseases (NIAID)