Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors For The Treatment Of Multiple Myeloma
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|ClinicalTrials.gov Identifier: NCT00185653|
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : February 14, 2011
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|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Procedure: Autologous followed by non-myeloablative allogeneic transplantation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors for the Treatment of Multiple Myeloma|
|Study Start Date :||October 2000|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
- Feasibility and laboratory-measured efficacy of mixed chimera unrelated donor allogeneic transplants.
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|Ages Eligible for Study:||18 Years to 60 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Inclusion Criteria: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 Criteria: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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185653
|United States, California|
|Stanford University School of Medicine|
|Stanford, California, United States, 94305|
|Principal Investigator:||Robert Lowsky||Stanford University|
|Responsible Party:||Robert Lowsky, Principal Investigator, Stanford University School of Medicine|
|Other Study ID Numbers:||
|First Posted:||September 16, 2005 Key Record Dates|
|Last Update Posted:||February 14, 2011|
|Last Verified:||February 2011|
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Blood Protein Disorders
Immune System Diseases