Status:
COMPLETED
Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors For The Treatment Of Multiple Myeloma
Lead Sponsor:
Stanford University
Conditions:
Multiple Myeloma
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The purpose of the study is to determine the toxicity and feasibility of non-myeloablative allogeneic hematopoietic cell transplants for multiple myeloma from unrelated donors.
Detailed Description
The primary objective of the protocol is to evaluate the toxicity and tolerability of this mixed chimerism matched unrelated donor allogeneic transplant approach for patients with multiple myeloma. Re...
Eligibility Criteria
Inclusion
- a) Multiple myeloma which is responsive to therapy. Eligible patients may have early or relapsed disease. Patients must have Stage II-III disease or have progression after initial treatment of Stage I disease. Patients who have relapsed following autologous transplantation may be eligible for this protocol.
- b) Age \<= 60 years. c) No prior therapy which would preclude the use of low-dose total body irradiation.
- d) Patients must have their pathology reviewed and the diagnosis confirmed at Stanford University Medical Center. Patients with smoldering multiple myeloma, monoclonal gammopathy of unknown significance, or amyloidosis will be excluded from this study.
- e) Patients must have a Karnofsky performance status \> 70%. f) DLCO \>= 60% predicted. g) ALT and AST must be \< 2X normal. Total bilirubin less than 2 mg/dl. h) Serum creatinine \< 2.0 or 24-hour creatinine clearance \>= 50 ml/min. i) Patients must be HIV negative. j) Pregnant or lactating women will not be eligible to participate. k) Patients must provide signed, informed consent.
Exclusion
- a) Severe psychological or medical illness b) Patients who have undergone prior allogeneic hematopoietic cell transplantation will not be eligible for this study.
- c) Patients who have an HLA-identical sibling donor will be excluded
Key Trial Info
Start Date :
October 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2008
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00185653
Start Date
October 1 2000
End Date
November 1 2008
Last Update
February 14 2011
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305