2023-505200-33-00招募中3 期
C1071015 - ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Pfizer Inc.
- 入组人数
- 14
- 试验地点
- 8
- 主要终点
- Nonserious adverse events (AEs) leading to permanent discontinuation of elranatamab
研究概览
简要总结
To monitor the safety of elranatamab.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants must agree to follow the Contraceptive and Barrier Guidance.
- •Participants have completed a qualifying Parent Study, were still receiving elranatamab when the Parent Study terminated or completed, and are deriving clinical benefit from elranatamab (as determined by the investigator).
排除标准
- •Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.
- •Participants not previously enrolled or who have discontinued study treatment in a Parent Study are ineligible for participation in this study.
结局指标
主要结局
Nonserious adverse events (AEs) leading to permanent discontinuation of elranatamab
Nonserious adverse events (AEs) leading to permanent discontinuation of elranatamab
All SAEs (Serious Adverse Event).
All SAEs (Serious Adverse Event).
次要结局
未报告次要终点
研究者
Clinical Medical Lead
Scientific
Pfizer Inc.
研究点 (8)
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