ELRANATAMAB POST TRIAL ACCESS: AN OPEN-LABEL, SINGLE-ARM STUDY FOR PARTICIPANTS WITH MULTIPLE MYELOMA CONTINUING FROM PFIZER-SPONSORED ELRANATAMAB CLINICAL STUDIES
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- Pfizer
- 入组人数
- 80
- 试验地点
- 56
- 主要终点
- Incidence of nonserious adverse events (AEs) leading to permanent discontinuation
研究概览
简要总结
This is a post-trial access (PTA) open-label, single-arm study in Multiple Myeloma participants who continue to derive clinical benefit from elranatamab monotherapy in the Pfizer-sponsored elranatamab Parent Studies.
详细描述
This is a single-arm elranatamab post-trial access study. Participants will receive elranatamab. All participants will receive elranatamab until disease progression, unacceptable toxicity, withdrawal of consent, study termination or, elranatamab becomes commercially accessible in the participant's country.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Participants must agree to follow the reproductive criteria as outlined in the protocol
- •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.
研究组 & 干预措施
Elranatamab
Elranatamab is a heterodimeric humanized full length bispecific IgG2 kappa antibody that targets BCMA on MM cells and CD3 on T cells
干预措施: Elranatamab (Drug)
结局指标
主要结局
Incidence of nonserious adverse events (AEs) leading to permanent discontinuation
时间窗: A minimum of 90 days after the last dose of study drug
Incidence of serious adverse events (SAEs)
时间窗: A minimum of 90 days after the last dose of study drug
次要结局
未报告次要终点