Clinical trial NCT00062621: Combined Bone Marrow and Kidney Transplant for Multiple Myeloma With Kidney Failure
Official title: Combined HLA-matched Bone Marrow and Kidney Transplantation for Multiple Myeloma With Renal Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Failure, Chronic
Multiple Myeloma
Keywords: 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
Lead sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Sponsor class: NIH
Collaborators: name: Immune Tolerance Network (ITN)
First posted: 2003-06-12
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Remission status of multiple myeloma
timeFrame: Throughout study
measure: Renal allograft acceptance and ability to discontinue immunosuppressive therapy
timeFrame: Throughout study
Secondary outcomes:
measure: Graft vs. host disease (GVHD)
timeFrame: Throughout study
measure: Opportunistic infections
timeFrame: Throughouto study
measure: T-cell recovery and immune reconstitution
timeFrame: Throughout study
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachussetts General Hospital
name: Thomas Spitzer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachussetts General Hospital
name: A. Benedict Cosimi, MD
role: PRINCIPAL_INVESTIGATOR
References: