Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

Not Recruiting

Trial ID: NCT00899847

Purpose

To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.

Official Title

A Phase 2 Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients

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)

Robert Negrin
Robert Negrin

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

Sally Arai
Sally Arai

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

Judith Shizuru
Judith Shizuru

Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and of Pediatrics (Stem Cell Transplantation)

Eligibility


PARTICIPANT INCLUSION CRITERIA

   - Stage II-III multiple myeloma or have progression after initial treatment of Stage I
   disease (Durie Salmon Staging). Patients with plasma cell leukemia are also included.

   - Multiple myeloma / plasma cell leukemia diagnosis confirmed by pathology reviewed at
   Stanford University Medical Center.

   - 18 to ≤ 75 years of age

   - Karnofsky Performance Status > 70%.

   - Corrected Carbon monoxide diffusing capacity (Dlco) > 60%

   - Left ventricle ejection fraction (LVEF) > 50%.

   - Alanine aminotransferase (ALT) ≤ 2 x normal

   - Aspartate aminotransferase (AST) ≤ 2 x normal

   - Total bilirubin ≤ 2 mg/dL, unless hemolysis or Gilbert's disease.

   - Estimated creatinine clearance > 50 mL/min.

   - Identified related or unrelated Human leukocyte antigen (HLA)-identical donor or donor
   with one antigen/allele mismatch in (HLA-A, B, C or DRB1).

   - Signed informed consent.

DONOR INCLUSION CRITERIA

   - At least 17 years of age

   - HIV-seronegative

   - Must be capable of giving signed, informed consent

   - No contraindication to the administration of filgrastim

   - Willing to have a central venous catheter placed for apheresis if peripheral veins are
   inadequate

PARTICIPANT EXCLUSION CRITERIA

   - Prior allogeneic hematopoietic cell transplantation

   - Uncontrolled active infection

   - Uncontrolled congestive heart failure or angina

   - HIV-positive

   - Pregnant or nursing

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

drug: cyclosporine

procedure: Autologous peripheral blood stem cells (auto-PBSC) transplantation

procedure: Allogeneic peripheral blood stem cells (allo-PBSC) transplantation

drug: Filgrastim

radiation: Total lymphoid irradiation

biological: Rabbit anti-thymocyte globulin

drug: Mycophenolate Mofetil 250mg

drug: Solumedrol

drug: Diphenhydramine

drug: Acetaminophen

drug: Hydrocortisone

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
BMT Referrals
6507230822

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