NCT00185653已完成不适用
Mixed Chimera Allogeneic Transplantation From Matched Unrelated Donors for the Treatment of Multiple Myeloma
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Feasibility and laboratory-measured efficacy of mixed chimera unrelated donor allogeneic transplants.
研究概览
简要总结
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.
详细描述
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. Response, toxicity, survival and graft-versus-host disease will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Feasibility and laboratory-measured efficacy of mixed chimera unrelated donor allogeneic transplants.
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
Unknown
2 期
Tandem Autologous- Nonmyeloablative Allogeneic Transplant for Newly Diagnosed Multiple Myeloma (Trapianto Tandem Autologo-Allogenico Non Mieloablativo Nel Mieloma Alla Diagnosi)Multiple MyelomaNCT00702247Azienda Ospedaliera San Giovanni Battista
已完成
2 期
Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple MyelomaBlood CancerMultiple MyelomaNCT00185614Wen-Kai Weng63
已完成
不适用
Feasibility study of nonmyeloablative allogeneic stem cell transplantation as a consolidation after autologous peripheral blood stem cell transplantation for multiple myeloma with poor prognosisMultiple myelomaJPRN-UMIN000001962agoya Blood and Marrow Transplantation Group22
已完成
1 期
Renal Allograft Tolerance Through Mixed ChimerismEnd Stage Renal DiseaseNCT01780454Massachusetts General Hospital2
已完成
1 期
Renal Allograft Tolerance Through Mixed Chimerism (Belatacept)Kidney Failure, ChronicRenal InsufficiencyNCT02314403Massachusetts General Hospital2