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Ph II of Autologous Followed by Nonmyeloablative Allogeneic Transplantation Using TLI & ATG

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Transplantation, Homologous; Transplantation, Autologous; Multiple Myeloma; Blood and Marrow Transplant (BMT)

Intervention: Autologous/Allogeneic HCT (Procedure); cyclophosphamide (Drug); filgrastim (Biological); melphalan (Drug); peripheral blood stem cell transplantation (Procedure); total nodal irradiation (Radiation); anti-thymocyte globulin (Biological); cyclosporine (Drug); mycophenolate mofetil (Drug); nonmyeloablative allogeneic hematopoietic stem cell transplantation (Procedure); laboratory biomarker analysis (Other)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Wen-Kai Weng, Principal Investigator, Affiliation: Stanford University

Summary

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

Clinical Details

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

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Incidence of Graft-versus-host disease

Secondary outcome: Relapse, Event free survival, Overall survival

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Stanford University School of Medicine, Stanford, California 94305, United States
Additional Information

Starting date: May 2009
Last updated: October 29, 2013

Page last updated: August 23, 2015

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