A Phase II Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- Laura Johnston, MD
- Robert Negrin, M.D.
- Wen-Kai Weng, MD, PhD
- Robert Lowsky, MD
- Sally Arai, MD
- Ginna G. Laport
- Judith Shizuru, Ph.D., M.D.
- biological : anti-thymocyte globulin
- biological : filgrastim
- drug : melphalan
- drug : cyclosporine
- drug : mycophenolate mofetil
- drug : cyclophosphamide
- other : laboratory biomarker analysis
- procedure : nonmyeloablative allogeneic hematopoietic stem cell transplantation
- procedure : Autologous/Allogeneic HCT
- procedure : peripheral blood stem cell transplantation
- radiation : total nodal irradiation
Phase: Phase 2
Ages Eligible For Study:
3.1.1 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. 3.1.2 Pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. 3.1.3 Age > 18 years and <= 75 years. 3.1.4 Karnofsky Performance Status > 70%. 3.1.5 Corrected DLCO > 60% 3.1.6 Left ventricle ejection fraction (LVEF) > 50%. 3.1.7 ALT and AST must be <= 2X normal. Total bilirubin <= 2 mg/dL unless hemolysis or Gilbert's disease. 3.1.8 Estimated creatinine clearance > 50 ml/min. 3.1.9 Have a related or unrelated HLA-identical donor or one antigen/allele mismatched in HLA-A, B, C or DRB1. 3.1.10 Signed informed consent. 3.3 Donor Evaluation Inclusion Criteria 3.3.1 Age >=17. 3.3.2 HIV seronegative 3.3.3 Donor must be capable of giving signed, informed consent 3.3.4 No contraindication to the administration of G-CSF 3.3.5 Willing to have a central venous catheter placed for apheresis if peripheral veins are inadequate.