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

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

Sponsoren

Hauptsponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Mitarbeiter: Immune Tolerance Network (ITN)

Quelle National Institute of Allergy and Infectious Diseases (NIAID)
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum June 2003
Fertigstellungstermin December 2006
Primäres Abschlussdatum December 2006
Phase Phase 1
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Remission status of multiple myeloma Throughout study
Renal allograft acceptance and ability to discontinue immunosuppressive therapy Throughout study
Sekundäres Ergebnis
Messen Zeitfenster
Graft vs. host disease (GVHD) Throughout study
Opportunistic infections Throughouto study
T-cell recovery and immune reconstitution Throughout study
Einschreibung 5
Bedingung
Intervention

Interventionsart: Procedure

Interventionsname: Combined bone marrow and kidney transplant

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 65 Years

Gesunde Freiwillige: No

Insgesamt offiziell
Ort
Einrichtung: Massachusetts General Hospital
Standort Länder

United States

Überprüfungsdatum

February 2013

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Zuweisung: Non-Randomized

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov