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

Phase 1
18 Years
65 Years
Not Enrolling
Kidney Failure, Chronic, Multiple Myeloma

Thank you

Trial Information

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

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

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

Type of Study:


Study Design:

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

Outcome Measure:

Remission status of multiple myeloma

Outcome Time Frame:

Throughout study

Safety Issue:


Principal Investigator

Thomas Spitzer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachussetts General Hospital


United States: Federal Government

Study ID:




Start Date:

June 2003

Completion Date:

December 2006

Related Keywords:

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



Massachusetts General Hospital Boston, Massachusetts  02114-2617