Ph II of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG
This trial is active, not recruiting.
|Conditions||transplantation, homologous, transplantation, autologous, multiple myeloma, blood and marrow transplant (bmt)|
|Treatments||autologous/allogeneic hct, cyclophosphamide, filgrastim, melphalan, peripheral blood stem cell transplantation, total nodal irradiation, anti-thymocyte globulin, cyclosporine, mycophenolate mofetil, nonmyeloablative allogeneic hematopoietic stem cell transplantation, laboratory biomarker analysis|
|Start date||May 2009|
|End date||November 2015|
|Trial size||43 participants|
|Trial identifier||NCT00899847, BMT201, SU-04142009-2259|
To evaluate the toxicity and tolerability of this tandem autologous/allogeneic transplant approach for patients with advanced stage multiple myeloma.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Incidence of Graft-versus-host disease
time frame: wo years after the last participant is enrolled.
Relapse, Event free survival, Overall survival
time frame: Two years after the study closes to accrual
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria: 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. Exclusion Criteria: 3.2.1 Prior allogeneic hematopoietic cell transplantation. 3.2.2 Uncontrolled active infection. 3.2.4 Uncontrolled congestive heart failure or angina. 3.2.5 Pregnancy or nursing patients will be excluded from the study. 3.2.6 Those who are HIV-positive will be excluded from the study due to high risk of lethal infection after hematopoietic cell transplantation. 3.4 Donor Evaluation Exclusion Criteria 3.4.1 Serious medical or psychological illness. 3.4.2 Pregnant or lactating women are not eligible 3.4.3 Prior malignancies within the last 5 years except for non-melanoma skin cancers
|Official title||A Phase II Study of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using Total Lymphoid Irradiation (TLI) and Antithymocyte Globulin (ATG) in Multiple Myeloma Patients|
|Principal investigator||Wen-Kai Weng|
Call for more information