NCT00998270Unknown2 期
A Prospective, Randomized Trial of Autologous Bone Marrow Transplantation Compare With Allogeneic Bone Marrow Transplantation in Multiple Myeloma
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Overall Survival and Progressive Free Survival in both two arms
研究概览
简要总结
A prospective, randomized trial of autologous bone marrow transplantation compared with allogeneic bone marrow transplantation in multiple myeloma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age at diagnosis equal or under 55 year
- •Meeting the Durie and Salmon criteria for initial diagnosis of MM
- •Stage II or III MM at diagnosis or anytime thereafter
- •Symptomatic MM requiring treatment at diagnosis or anytime thereafter
- •If receiving chemotherapy-based mobilization regimens, must be able to receive high-dose melphalan between 2 and 8 weeks after the initiation of mobilization therapy whether delivered at the transplant center or at a referring center
- •Adequate organ function as measured by:
- •Cardiac: Left ventricular ejection fraction at rest greater than 40%
- •Hepatic: Bilirubin less than 2 times the upper limit of normal and ALT and AST less than 3 times the upper limit of normal
- •Renal: Creatinine clearance greater than 40 ml/min (measured or calculated/estimated)
- •Pulmonary: DLCO, FEV1, and FVC greater than 50% of predicted value (corrected for hemoglobin), or O2 saturation greater than 92% of room air
- •An adequate autologous graft defined as a cryopreserved PBSC graft containing at least 4.0 x 10^6 CD34+ cells/kg patient weight; if prior to enrollment it is known that a patient will be on the auto-allo arm (i.e., a consenting, eligible HLA-matched sibling donor is available), the required autograft must contain at least 2.0 x 10^6 CD34+ cells/kg patient weight; the graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells; the graft can be collected at the transplanting institution or by a referring center; for patients without an HLA-matched sibling donor, the autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight
排除标准
- •Never advanced beyond Stage I MM since diagnosis
- •Non-secretory MM (absence of a monoclonal protein [M protein] in serum as measured by electrophoresis and immunofixation and the absence of Bence Jones protein in the urine defined by use of conventional electrophoresis and immunofixation techniques)
- •Plasma cell leukemia
- •Karnofsky performance score less than 70%, unless approved by the Medical Monitor or one of the Protocol Chairs
- •Uncontrolled hypertension
- •Uncontrolled bacterial, viral, or fungal infections (currently taking medication and progression of clinical symptoms)
- •Prior malignancies except resected basal cell carcinoma or treated cervical carcinoma in situ; cancer treated with curative intent less than 5 years previously will not be allowed unless approved by the Medical Monitor or one of the Protocol Chairs; cancer treated with curative intent more than 5 years previously will be allowed
- •Pregnant or breastfeeding
- •Seropositive for the human immunodeficiency virus (HIV)
- •Unwilling to use contraceptive techniques during and for 12 months following treatment
- •Prior allograft or prior autograft
- •Received mid-intensity melphalan (more than 50 mg IV) as part of prior therapy
- •Prior organ transplant requiring immunosuppressive therapy
结局指标
主要结局
Overall Survival and Progressive Free Survival in both two arms
时间窗: 1 year
次要结局
- Overall Survival and Progressive Free Survival in both two arms(3 year)
- Treatment Related Mortality (TRM) in both two arms(3 year)
- Acute and Chronic GVHD in Allogeneic arm(3 year)
研究者
研究点 (1)
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