Prospective Observation of Cardiac Safety With Proteasome Inhibition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Frequency of cardiac events of patients receiving PIs for MM.
研究概览
简要总结
The purpose of this study is to better define and understand potential cardiac toxicities of proteasome inhibitors and to understand optimal management strategies to treat and prevent cardiovascular events.
详细描述
Cancer treatments, using proteasome inhibitors, have the potential in induce cardiac toxicities including heart failure (HF), hypertension, arrhythmias and ischemic heart disease. While the presence of cardiac events may be a class effect of proteasome inhibitors (PI), the effect may be more profound with the irreversible inhibition of carfilzomib compared with reversible inhibition with bortezomib. Data available from currently published clinical trials may be inadequate to fully understand the incidence and severity of cardiac injury in patients treated with proteasome inhibitors because the trials were not designed to fully assess cardiac events. The purpose of this study is to better define and understand potential cardiac toxicity and begin to understand optimal management strategies.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed multiple myeloma at any time-point in treatment course and planning to start a proteasome inhibitor-based therapy as part of standard care
- •Received at least one prior line of therapy for multiple myeloma (induction therapy followed by stem cell transplant and consolidation/maintenance therapy will be considered as one line of therapy)
- •Males and females ≥ 18 years of age
- •Able to provide written informed consent in accordance with federal, local, and institutional guidelines
排除标准
- •POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes)
- •Known or suspected AL amyloidosis, secondary amyloidosis or cardiac amyloidosis
- •Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
- •Waldenström Macroglobulinemia
- •Myelodysplastic syndrome
- •History of MI within the last 3 months
- •Symptomatic unstable cardiac arrhythmia requiring treatment in the past 3 months
- •Class 3 or 4 New York Heart Association Heart Failure in the past 3 months
- •Any other clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a subject's ability to give informed consent
结局指标
主要结局
Frequency of cardiac events of patients receiving PIs for MM.
时间窗: 18 months
次要结局
未报告次要终点