A Multi-center Observational Study of the Effectiveness of Elranatamab in Patients With Relapsed and/or Refractory Multiple Myeloma in Taiwan
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
- 1
- 试验地点
- 4
- 主要终点
- rwTTNT (real world time to next treatment)
研究概览
简要总结
The purpose of this study is to evaluate:
- What is the real-world effectiveness of elranatamab in patients with relapsed and/or refractory multiple myeloma (RRMM) in Taiwan?
- What are the baseline and clinical characteristics of RRMM patients who have received eltanatamab in Taiwan?
- What are the treatment patterns of RRMM patients receiving elranatamab in the real-world setting in Taiwan?
详细描述
This study is seeking participants who:
- have relapsed or refractory multiple myeloma (RRMM),
- have received at least four prior lines of therapy (including a PI, an IMiD, and an anti-CD38 antibody),
- are 18 years or older.
Participants receive elranatamab according to the approved label in Taiwan and continue treatment until disease progression or discontinuation. The study will evaluate real-world effectiveness and describe patient characteristics and treatment patterns to better understand elranatamab use in routine care.
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 age ≥ 18 years at the initiation of elranatamab
- •Patients who have received at least one dose of elranatamab in consistent with the approved label in Taiwan.
- •Evidence of a personally signed and dated informed consent document (ICD) indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. The ICD waiver is acceptable for patient who was ceased before recruitment.
排除标准
- •Patients who participated in any prior clinical trials using elranatamab.
研究组 & 干预措施
Elranatamab in Patients with Relapsed and/or Refractory Multiple Myeloma
Patients with Relapsed and/or Refractory Multiple Myeloma treated with Elranatamab
干预措施: Non intervention (Drug)
结局指标
主要结局
rwTTNT (real world time to next treatment)
时间窗: From initiation of elranatamab treatment (index date) until 18 months
Time from index date to initiation of the next line of anti-myeloma therapy or end of study.
rwTTR (real-world time to response)
时间窗: At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.)
Time from index date to the first documented real-world response.
rwORR (real-world overall response rate)
时间窗: At 1 month, 3 months, 6 months, 9 months, 12 months, and 18 months following initiation of elranatamab treatment (index date.)
Proportion of patients achieving real-world overall response at predefined assessment time points.
rwDOR (real-world duration of response）
时间窗: From first response until 18 months
Time from the first documented real-world response to real-world disease progression, death, or end of study.
rwPFS (real-world progression-free survival)
时间窗: From initiation of elranatamab treatment (index date) until 18 months
Time from index date to the first documented real-world disease progression or death.
rwOS (real world overall survival)
时间窗: From initiation of elranatamab treatment (index date) until 18 months
Time from index date to death from any cause.
次要结局
- Demographic: Age(At baseline)
- Demographic: Sex(From MM diagnosis until index date, and from index date until 18 months)
- Anthropometric Measures(At baseline)
- ECOG Performance Status(At baseline)
- Myeloma-related Clinical Characteristics(At baseline)
- Laboratory Characteristics(At baseline)
- Prior Treatment History(At baseline)
- Time from Diagnosis and Line of Elranatamab Treatment(From the index date (initiation of elranatamab treatment) up to 18 months)
- Elranatamab Discontinuation and Treatment Modifications(From the index date (initiation of elranatamab treatment) up to 18 months)
- Subsequent Treatments After Progression(From the index date (initiation of elranatamab treatment) up to 18 months)