Health-Related Quality of Life (HRQoL) in Patients With Relapsed and/or Refractory Multiple Myeloma (RRMM) With Triple Class Exposure in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30
研究概览
简要总结
The purpose of this observational study is to assess HRQoL in relapsed and/or refractory multiple myeloma (RRMM) participants who have previously received a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have sufficient command of the Japanese language to understand the study instructions and requirements
- •Must be a resident of Japan
- •Must have received prior treatment with:
- •a proteasome inhibitor,
- •an immunomodulatory agent, and
- •an anti-CD38 antibody Subjects must be either 2-4 months, 5-7 months, or 8-11 months post triple class therapy exposure at time of consent
- •Subject must be diagnosed with multiple myeloma
排除标准
- •Participants enrolled in a clinical trial that includes at least one novel/ experimental agent at the point of questionnaire completion
- •Other protocol-defined inclusion/exclusion criteria apply.
结局指标
主要结局
Health-Related Quality of Life (HRQoL) in specific domains: Fatigue, as measured by EORTC QLQ-C30
时间窗: Up to 1 year
EORTC QLQ-C30 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30
HRQoL in specific domains: Pain, as measured by the EORTC QLQ-C30
时间窗: Up to 1 year
HRQoL in specific domains: Cognitive Functioning, as measured by the EORTC QLQ-C30
时间窗: Up to 1 year
HRQoL in specific domains: Global health, as measured by the EORTC QLQ-C30
时间窗: Up to 1 year
HRQoL in specific domains: Disease Symptoms as measured by the EORTC QLQ-MY20
时间窗: Up to 1 year
EORTC QLQ-MY20 defined as European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-MY20
HRQoL in specific domains: Physical Functioning as measured by the EORTC QLQ-C30
时间窗: Up to 1 year
HRQoL in specific domains: Side effects as measured by the EORTC QLQ-MY20
时间窗: Up to 1 year
次要结局
- HRQoL in specific domains: Functional Scale as measured by the EORTC QLQ-C30(Up to 1 year)
- HRQoL in specific domains: Symptoms Scale as measured by the EORTC QLQ-C30(Up to 1 year)
- HRQoL in specific domains: Body Image as measured by the EORTC QLQ-MY20(Up to 1 year)
- HRQoL in specific domains: Generic HRQoL as measured by the EQ-5D-5L(Up to 1 year)
- HRQoL in specific domains: Global Health Status as measured by the EORTC QLQ-C30(Up to 1 year)
- HRQoL in specific domains: Future Perspective as measured by the EORTC QLQ-MY20(Up to 1 year)