NCT02026505已完成不适用
Prospective Assessment of the Cardiac Effects the Proteasome Inhibitor Bortezomib in Patients Undergoing Therapy for Multiple Myeloma
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 主要终点
- Global longitudinal strain by echocardiography
研究概览
简要总结
The purpose of this study is to learn more about how a drug commonly used to treat multiple myeloma can affect the heart.
In this study, the investigators will learn whether a drug called how a drug (called bortezomib, or Velcade) receive for multiple myeloma affects the heart. Bortezomib is part of the standard treatment and its effects on multiple myeloma is not being studied here.
The investigators want to learn whether damage occurs to the heart after taking bortezomib for multiple myeloma, whether it is reversible, and we can predict damage to the heart before it occurs.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of multiple myeloma
- •have a treatment plan involving greater than 4 cycles of bortezomib-based chemotherapy
排除标准
- •pre-existing history of left ventricular systolic dysfunction
- •congestive heart failure
- •coronary artery disease
- •significant valvular heart disease
- •cardiac arrhythmias
- •estimated glomerular filtration rate <30 mL/min/1.73m2
研究组 & 干预措施
Multiple Myeloma, Bortezomib
干预措施: Bortezomib (Drug)
结局指标
主要结局
Global longitudinal strain by echocardiography
时间窗: 6 months
次要结局
- Carboxyl-terminal telopeptide of collagen type I(6 months)
- Amino-terminal peptide of procollagen type III(6 months)
- Amount of late gadolinium enhancement by cardiac MRI(6 months)
- High-sensitivity troponin T(6 months)
- C-reactive protein(6 months)
- Serum NT-proBNP(6 months)
研究者
Stephen Heitner
Assistant Professor of Medicine
Oregon Health and Science University
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