Korean Post Marketing Surveillance for ELREXFIO (Elranatamab).
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Incidence of an adverse event (AE)/ adverse drug reaction (ADR)
研究概览
简要总结
This study is to assess the safety and effectiveness of Elranatamab in the real-world clinical settings for the treatment of patients with multiple myeloma in Korea.
详细描述
This study is an open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Elranatamab in the real-world clinical setting in patients with multiple myeloma in Korea.
During the study period within 2 years from the launch date, a whole case enrollment should be conduct according to the protocol.
The objectives of this study are to determine safety and effectiveness with Elranatamab under conditions of general clinical practice, in compliance with the regulation of the MFDS. Therefore, this study was designed according to the PMS guidelines of the MFDS.
The study population is patients who are eligible for "Indications" specified in the approved label.
All assessments described in this protocol are performed as part of normal clinical practice or standard practice guidelines for the patient population and healthcare provider specialty in the countries where this Non-interventional study (NIS) is being conducted.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Patients who have been prescribed ELREXFIO (Elranatamab) by their physician as monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
- •Patients with evidence of a personally signed and dated informed consent/assent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
排除标准
- •Patients with contraindication according to locally approved label of ELREXFIO (Elranatamab)
- •Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
研究组 & 干预措施
Elranatamab
Patients who have been prescribed Elranatamab by their physician as monotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least three prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, and have demonstrated disease progression on the last therapy.
干预措施: Elranatamab (Drug)
结局指标
主要结局
Incidence of an adverse event (AE)/ adverse drug reaction (ADR)
时间窗: At least 28 days from the last dose of Elranatamab
The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation. The numbers and proportions of patients experiencing AE and ADR will be summarized with the 95% CIs in addition to their occurrence frequencies.
Incidence of a serious AE (SAE)/ serious ADR (SADR)
时间窗: At least 28 days from the last dose of Elranatamab
The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation. The numbers and proportions of patients experiencing SAE and SADR will be summarized with the 95% CIs in addition to their occurrence frequencies.
Incidence of an unexpected AE (UAE)/ unexpected ADR (UADR)
时间窗: At least 28 days from the last dose of Elranatamab
The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation. The numbers and proportions of patients experiencing UAE and UADR will be summarized with the 95% CIs in addition to their occurrence frequencies.
Incidence of a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR)
时间窗: At least 28 days from the last dose of Elranatamab
The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation. The numbers and proportions of patients experiencing SUAE and SUADR will be summarized with the 95% CIs in addition to their occurrence frequencies.
Incidence of an adverse event special interest (AESI)
时间窗: At least 28 days from the last dose of Elranatamab
The safety analysis population will consist of all patients who received at least one dose of the study drug and had at least one follow-up safety evaluation. The numbers and proportions of patients experiencing AESI will be summarized with the 95% CIs in addition to their occurrence frequencies.
次要结局
- Objective response rate (ORR) per International Myeloma Working Group (IMWG) response criteria as determined by investigator(From the first dose of the study drug until completion or discontinuation of the study or death due to any cause, whichever occurs first, assessed up to 72 months.)
- Progression-free survival (PFS) per IMWG response criteria as determined by investigator(From the first dose of the study drug until confirmed Progressive Disease per IMWG criteria or death due to any cause, whichever occurs first, assessed up to 72 months.)
- Time to response (TTR) per IMWG response criteria as determined by investigator(From the first dose of the study drug to the first documentation of response that is subsequently confirmed, assessed up to 72 months.)