A National, Prospective, Non-interventional Study of NINLARO in Real World Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 482
- 试验地点
- 28
- 主要终点
- Number of Participants who Have one or More Adverse Events
研究概览
简要总结
The main purpose of this study is to collect additional safety information of ixazomib citrate (Ninlaro) when used to treat multiple myeloma in real world clinical practice in China. Participants will be treated with Ninlaro according to the normal clinical practice during this study.
详细描述
This is a prospective, non-interventional study in Chinese participants with relapsed refractory multiple myeloma (RRMM), newly diagnosed multiple myeloma (NDMM) and non-myeloma who are undergoing or will receive at least one dose of ixazomib citrate. Data will be collected to assess safety information when NINLARO is used in the real world, based on known risks and missing safety information.
The study will enroll approximately 3000 patients. The data will be collected prospectively as part of routine clinical visits of participants. Participants will be assigned to one of the two observational cohorts:
- Cohort 1: Participants with RRMM
- Cohort 2: Participants with NDMM, RRMM, and Non-myeloma
The multi-center trial will be conducted in China. The overall duration of study will be approximately 64 months. All participants will be followed up for 21 months unless withdrawal of Informed Consent Form, loss of follow-up or death, whichever comes first.
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
- •Undergoing treatment with Ninlaro (of less than 3 months from initial treatment with Ninlaro) or to be prescribed with Ninlaro capsule.
- •Participants will be able to sign Informed Consent Form to participate.
排除标准
- •Currently participates or plans to participate in any interventional clinical trial.
- •Any other reason that, in the Investigator's opinion, makes the participant unsuitable to participate in this study.
研究组 & 干预措施
Cohort 1: Participants with RRMM
Participants diagnosed with relapsed or refractory multiple myeloma (RRMM) who have received at least one dose of ixazomib plus lenalidomide - low dose dexamethasone (IRd) treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information.
Cohort 2: Participants with NDMM, RRMM, and Non-myeloma
Participants diagnosed with NDMM who have received at least one dose of ixazomib-based regimen treatment, diagnosed with RRMM who have received at least one dose non-IRd ixazomib-based regimens treatment, and diagnosed with non-myeloma who have received at least one dose of ixazomib-based regimens treatment, will be observed prospectively. Data will be collected from study sites such as clinical departments and pharmacies in hospitals as a part of routine clinical visits of participants to evaluate effectiveness and safety information.
结局指标
主要结局
Number of Participants who Have one or More Adverse Events
时间窗: From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64)
次要结局
- Number of Participants Based on Disease Characteristics(Up to Month 64)
- Number of Participants With Dose Adjustments During the Study(Up to Month 64)
- Number of Participants Reporting one or More Serious Adverse Events (SAEs), Adverse Drug Reaction (ADRs) and Adverse Events of Special Interest (AESI)(From signing of the informed consent to 60 days after administration of the last dose of NINLARO (Up to Month 64))
- Number of Participants Categorized by Clinical Characteristics(Up to Month 64)
- Number of Participants With Multiple Myeloma Treatment(Up to Month 64)
- Overall Survival (OS)(From the date of sign Informed Consent Form to the date of death due to any cause (Up to Month 64))