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Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors for the Treatment of Multiple Myeloma

18 Years
60 Years
Not Enrolling
Multiple Myeloma

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Trial Information

Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors for the Treatment of Multiple Myeloma

The primary objective of the protocol is to evaluate the toxicity and tolerability of this
mixed chimerism matched unrelated donor allogeneic transplant approach for patients with
multiple myeloma. Response, toxicity, survival and graft-versus-host disease will be

Inclusion Criteria:

a) Multiple myeloma which is responsive to therapy. Eligible patients
may have early or relapsed disease. Patients must have Stage II-III disease or have
progression after initial treatment of Stage I disease. Patients who have relapsed
following autologous transplantation may be eligible for this protocol.

b) Age <= 60 years. c) No prior therapy which would preclude the use of low-dose total
body irradiation.

d) Patients must have their pathology reviewed and the diagnosis confirmed at Stanford
University Medical Center. Patients with smoldering multiple myeloma, monoclonal
gammopathy of unknown significance, or amyloidosis will be excluded from this study.

e) Patients must have a Karnofsky performance status > 70%. f) DLCO >= 60% predicted. g)
ALT and AST must be < 2X normal. Total bilirubin less than 2 mg/dl. h) Serum creatinine <
2.0 or 24-hour creatinine clearance >= 50 ml/min. i) Patients must be HIV negative. j)
Pregnant or lactating women will not be eligible to participate. k) Patients must provide
signed, informed consent.

Exclusion Criteria:a) Severe psychological or medical illness b) Patients who have
undergone prior allogeneic hematopoietic cell transplantation will not be eligible for
this study.

c) Patients who have an HLA-identical sibling donor will be excluded

Type of Study:


Study Design:

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

Outcome Measure:

Feasibility and laboratory-measured efficacy of mixed chimera unrelated donor allogeneic transplants.

Principal Investigator

Robert Lowsky

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Institutional Review Board

Study ID:




Start Date:

October 2000

Completion Date:

November 2008

Related Keywords:

  • Multiple Myeloma
  • Multiple Myeloma
  • Neoplasms, Plasma Cell



Stanford University School of MedicineStanford, California  94305-5317