Risk Factors for Dyspnea and Cardiotoxicity in Patients With Multiple Myeloma Who Receive Carfilzomib: A Prospective Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Endothelial Function and Dyspnea Associations in Multiple Myeloma Patients
研究概览
简要总结
This study will explore why some multiple myeloma patients who receive carfilzomib (an anti-cancer medication) experience shortness of breath while others do not. The purpose of this research is to gather information on the effectiveness of the EndoPAT device, which is FDA-approved to assess the health of a patient's blood vessels. These assessments will help doctors leading the study determine the reasons why patients may develop shortness of breath (dyspnea) when being treated with carfilzomib and ways to better prevent this shortness of breath.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Confirmed diagnosis of multiple myeloma
- •Newly-diagnosed multiple myeloma, or relapsed/refractory multiple myeloma with receipt of 1-3 previous lines of therapy and with a 2-week washout from prior therapy
- •Receiving carfilzomib as either standard-of-care therapy or as part of a clinical trial
排除标准
- •Previous receipt of anthracycline chemotherapy
- •Previous receipt of carfilzomib
- •Four or more previous lines of therapy
- •Active pregnancy at the time of enrollment
研究组 & 干预措施
Participants with Abnormal Baseline Endothelial Function
干预措施: Blood Tests (Other)
Participants with Normal Baseline Endothelial Function
干预措施: EndoPAT (Device)
Participants with Normal Baseline Endothelial Function
干预措施: Blood Pressure Cuff (Device)
Participants with Normal Baseline Endothelial Function
干预措施: Echocardiogram (Diagnostic Test)
Participants with Normal Baseline Endothelial Function
干预措施: Quality of Life Assessment (Other)
Participants with Normal Baseline Endothelial Function
干预措施: Blood Tests (Other)
Participants with Abnormal Baseline Endothelial Function
干预措施: EndoPAT (Device)
Participants with Abnormal Baseline Endothelial Function
干预措施: Blood Pressure Cuff (Device)
Participants with Abnormal Baseline Endothelial Function
干预措施: Echocardiogram (Diagnostic Test)
Participants with Abnormal Baseline Endothelial Function
干预措施: Quality of Life Assessment (Other)
结局指标
主要结局
Endothelial Function and Dyspnea Associations in Multiple Myeloma Patients
时间窗: 2 months
The association between baseline endothelial function and dyspnea in myeloma patients treated with carfilzomib. These associations will be assessed by comparing endothelial function within two cohorts: patients with abnormal baseline endothelial function, and patients with normal baseline endothelial function. Baseline endothelial function will be measured using EndoPat, an FDA-approved device used for health tests. Dyspnea rates will be assessed by participant-reported outcomes using the FACIT Dyspnea-10 Raw Dyspnea Score and Common Terminology Criteria for Adverse Events V5.
次要结局
- The Affects of Carfilzomib Dose/Dosing Schedule on the Incidence of Dyspnea(2 months)
- Cardiovascular Toxicities Associated with Changes in Carfilzomib-Induced Endothelial Function(2 months)
- Changes in Cardiovascular Physiology and Risk Factors Associated with Endothelial Function(2 months)