©2022 Stanford Medicine
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
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy) and, by courtesy, of Dermatology
Laura Johnston
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Negrin
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Robert Lowsky
Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
Sally Arai
Associate Professor of Medicine (Blood and Marrow Transplantation and Cellular Therapy)
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