自体移植高剂量美法仑与高剂量美法仑+硼替佐米在 65 岁或以上多发性骨髓瘤患者中的对比
(PRO#11307) 在 65 岁或以上的多发性骨髓瘤患者中,使用大剂量美法仑与大剂量美法仑和硼替佐米进行自体干细胞移植的 III 期随机研究
研究概览
详细说明
在这项研究中,研究人员正在将这种标准方案与新建立的美法仑和硼替佐米方案进行比较。
调理方案:
治疗组 A Melphalan 以 200mg/m2 的剂量通过中央或外周静脉快速静脉输注,持续 30 分钟至 1 小时。
美法仑将作为单剂量给药(不分 2 天或更多天给药)并在第 1 天给药。
剂量将基于使用实际体重计算的体表面积
干细胞输注:
干细胞输注将在第 0 天进行,并且将在输注美法仑后至少 20 小时进行。 外周血干细胞的输注将按照血液和骨髓移植计划的标准操作程序进行。
非格司亭将以 5 mcg/kg(四舍五入为小瓶大小)的剂量每隔一天从第 +3 天开始然后每天从第 9 天开始直到植入(至少)。
治疗臂 B
硼替佐米:
硼替佐米通过快速静脉注射给药。通过中央或外周静脉推入(超过 3-5 秒)流动的生理盐水管路。 硼替佐米将在第-4 天的任何时间和第-1 天美法仑输注开始后至少 20 小时给药。
剂量将基于实际体重。 每次硼替佐米输注前,地塞米松的剂量为 20 mg IV。
马法兰:
美法仑的剂量为 200mg/m2,通过中央或外周静脉快速静脉输注 30 分钟至 1 小时。
美法仑将作为单剂量给药(不分 2 天或更多天给药)并在第 2 天给药。
剂量将基于使用实际体重计算的体表面积
干细胞输注:
干细胞输注将在第 0 天进行,并且将在硼替佐米输注后至少 18 小时进行。 外周血干细胞的输注将按照血液和骨髓移植计划的标准操作程序进行。
非格司亭将以 5 mcg/kg(四舍五入为小瓶大小)的剂量每隔一天从第 +3 天开始然后每天从第 9 天开始直到植入(至少)。
移植后支持性护理将根据血液和骨髓移植计划标准操作程序进行管理。
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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District of Columbia
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Washington、District of Columbia、美国、20057
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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New Jersey
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Hackensack、New Jersey、美国、07601
- Hackensack University Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
描述
纳入标准:
- 自全身治疗开始后不到 12 个月确诊为多发性骨髓瘤
- 移植时年龄≥60岁
- 关键点 70-100%
- 从先前治疗的并发症中恢复
排除标准:
- 多发性骨髓瘤以外的诊断
- 在本研究中开始治疗后 8 天内接受化疗或放疗
- 在本研究中开始治疗后 56 天内的既往剂量强化治疗
- 不受控制的细菌、病毒、真菌或寄生虫感染
- 不受控制的 CNS 转移
- 已知淀粉样蛋白沉积在心脏
- 器官功能障碍
- LVEF <40% 或心力衰竭对治疗无反应
- FVC、FEV1 或 DLCO < 预测值的 40% 和/或接受补充性持续供氧
- 肝脏合成功能障碍或总胆红素 > 2x 或 AST > 3x ULN 的证据
- 测得的肌酐 < 20ml/min
- 入组后 14 天内感觉周围神经病变 4 级
- 卡诺夫斯基评分 < 70%
- 受其他合并症限制的预期寿命
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:处理A
美法仑的剂量为 200mg/m2,通过中央或外周静脉快速静脉输注 30 分钟至 1 小时。 美法仑将作为单剂量给药(不分 2 天或更多天给药)并在第 1 天给药。 剂量将基于使用实际体重计算的体表面积 干细胞输注: 干细胞输注将在第 0 天进行,并且将在输注美法仑后至少 20 小时进行。 外周血干细胞的输注将按照血液和骨髓移植计划的标准操作程序进行。 非格司亭将以 5 mcg/kg(四舍五入为小瓶大小)的剂量每隔一天从第 +3 天开始然后每天从第 9 天开始直到植入(至少)。 |
美法仑的剂量为 200mg/m2,通过中央或外周静脉快速静脉输注 30 分钟至 1 小时。 美法仑将作为单剂量给药(不分 2 天或更多天给药)并在第 1 天给药。 剂量将基于使用实际体重计算的体表面积 干细胞输注: 干细胞输注将在第 0 天进行,并且将在输注美法仑后至少 20 小时进行。 外周血干细胞的输注将按照血液和骨髓移植计划的标准操作程序进行。 非格司亭将以 5 mcg/kg(四舍五入为小瓶大小)的剂量每隔一天从第 +3 天开始然后每天从第 9 天开始直到植入(至少)。
其他名称:
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实验性的:治疗臂 B
硼替佐米: 硼替佐米通过快速静脉注射给药。通过中央或外周静脉推入(超过 3-5 秒)流动的生理盐水管路。 硼替佐米将在第-4 天的任何时间和第-1 天美法仑输注开始后至少 20 小时给药。 |
硼替佐米: 硼替佐米通过快速静脉注射给药。通过中央或外周静脉推入(超过 3-5 秒)流动的生理盐水管路。 硼替佐米将在第-4 天的任何时间和第-1 天美法仑输注开始后至少 20 小时给药。
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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无进展生存率
大体时间:移植后,参与者将被跟踪至少 3 年,之后可能会作为研究的一部分进行无限期监测
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老年多发性骨髓瘤患者接受高剂量美法仑与高剂量美法仑联合硼替佐米治疗后 3 年无进展生存期
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移植后,参与者将被跟踪至少 3 年,之后可能会作为研究的一部分进行无限期监测
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次要结果测量
结果测量 |
大体时间 |
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总生存率
大体时间:1年
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1年
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合作者和调查者
调查人员
- 首席研究员:Michele Donato, MD、John Theurer Cancer Center at Hackensack University Medical Center
出版物和有用的链接
一般刊物
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