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Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
Not Recruiting
Trial ID: NCT00185614
Purpose
Mixed chimerism transplantation is an approach to allogeneic transplants that attempts to
decrease regimen-related toxicity by using non-myeloablative preparatory regimens; establish
mixed chimerism using low dose total body irradiation along with immunosuppression using
cyclosporine and mycophenolate mofetil; suppress graft-vs-host and host-vs-graft reactions to
allow a mixed chimeric state to be established, encourage tolerance and prevent graft-vs-host
disease (GvHD) during the mixed chimerism period and use donor lymphocyte infusions to
convert the patient to a full chimera while developing a graft-vs-tumor effect.
Official Title
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma
Stanford Investigator(s)
Wen-Kai Weng, MD, PhD
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Eligibility
PATIENT INCLUSION CRITERIA
- Multiple myeloma, early Stage II-III or relapsed / progression after initial treatment
of Stage I disease
- Patient has HLA-identical sibling donor
- Age ≤ 70 years
- No prior therapy which would preclude the use of low-dose total body irradiation
- Pathology review and diagnosis confirmation by Stanford University Medical Center
- Karnofsky performance status (KPS) > 70%
- DLCO ≥ 60% predicted
- ALT and AST < 2 x upper limit of normal (ULN)
- Total bilirubin < 2 mg/dL
- Serum creatinine < 2.0, or 24-hour creatinine clearance ≥ 60 mL/min
- HIV-negative
- Signed informed consent document
PATIENT EXCLUSION CRITERIA
- Smoldering multiple myeloma; monoclonal gammopathy of unknown significance; or primary
amyloidosis
- Severe psychological or medical illness
- Prior allogeneic hematopoietic cell transplantation
- Pregnant or lactating
ALLOGENEIC DONOR INCLUSION CRITERIA
- Age ≥ 17
- HIV-seronegative
- Signed informed consent document
ALLOGENEIC DONOR EXCLUSION CRITERIA
- Serious medical or psychological illness
- Pregnant or lactating
- Prior malignancies within the last 5 years, except for non-melanoma skin cancers
Intervention(s):
drug: cyclophosphamide
drug: Melphalan
procedure: Autologous hematopoietic cell transplant (Auto-HCT)
procedure: Allogeneic hematopoietic cell transplant (Allo-HCT)
drug: Filgrastim
radiation: Total body irradiation (TBI)
procedure: Cyclosporine (CSP)
drug: Mycophenolate Mofetil (MMF)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
BMT Referrals
6507230822