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
Wen-Kai Weng, MD, PhD

Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology

Robert Lowsky
Robert Lowsky

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)

Laura Johnston
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

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