Comparative Effectiveness of Elranatamab in Clinical Study C1071003 Versus Physician's Choice of Treatment (PCT) in Real-World (RW) External Control Arms in Patients With Triple-Class Refractory (TCR) Multiple Myeloma (MM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Progression-free survival
研究概览
简要总结
This study is to understand how well elranatamab (PF-06863135) may be used for relapsed refractory multiple myeloma (RRMM). Sometimes MM might improve at first, but then gets resistant to the treatment and starts growing again (known as relapsed refractory). This study medicine will be compared with standard-of-care (SOC) therapies used in real-world clinical practice. For people receiving elranatamab, the investigators will use data from the phase 2 clinical trial (MagnetisMM-3). The investigators will also use data from a real-world data source, representing the SOC in clinical practice. This study does not seek any participants for enrollment. The investigators will compare the experiences of people receiving elranatamab to people receiving SOC therapies. This way, it will help the investigators to know how well elranatamab can be used for RRMM treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years and older at index date
- •Diagnosis of MM
- •Measurable disease according to IMWG criteria
- •ECOG performance status ≤2
- •Refractory to at least 1 proteasome inhibitor, 1 immunomodulatory drug, and 1 anti-CD38 treatment (ie, triple-class refractory [TCR])
- •At least 1 treatment following their TCR eligibility
排除标准
- •Acute plasma cell leukemia
- •Amyloidosis
- •Smoldering MM
- •Stem cell transplant within 12 weeks of index or active graft versus host disease (GVHD)
- •Active malignancy within 3 years before index, except for basal cell or squamous cell skin cancer or carcinoma in situ
- •Administration with an investigational drug within 30 days prior to index
研究组 & 干预措施
Elranatamab
Patients treated with elranatamab from the MagnetisMM-3 trial
干预措施: Elranatamab (Drug)
Standard of care
Patients treated with standard-of-care therapies from real-world data sources
干预措施: Standard of care (Drug)
结局指标
主要结局
Progression-free survival
时间窗: From the index therapy start until progression or death due to any cause, whichever occurs first, assessed up to 6 years
次要结局
- Overall surival(From the index therapy start until death due to any cause assessed up to 6 years)
- Duration of response(From the first documentation of objective response until progression or death due to any cause, whichever occurs first, assessed up to 6 years)