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Clinical Trials/CTR20250938
CTR20250938Active, not recruiting试验后用药研究

ELRANATAMAB 试验后用药：一项多发性骨髓瘤研究参与者继续参加辉瑞申办的 ELRANATAMAB 临床研究的开放性、单臂研究

Not provided18 sites in 6 countries5 target enrollmentStarted: March 14, 2025
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Trial Snapshot

Phase
试验后用药研究
Status
Active, not recruiting
Enrollment
5
Locations
18
Primary Endpoint
导致永久停用 elranatamab 的非严重不良事件 (AE)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Detailed Description

监测 elranatamab 的安全性

Study Design

Study Type
安全性
Allocation
非随机化
Intervention Model
单臂试验
Masking
开放

Eligibility Criteria

Ages
18岁(最小年龄) to 无上限 (—)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •研究参与者必须同意遵循避孕措施与屏障方法使用指导。
  • •研究参与者已完成一项符合要求的母研究，在母研究终止或完成时仍在接受 elranatamab 治疗，且正从 elranatamab 治疗得到临床获益（由研究者确定）。

Exclusion Criteria

  • •可能增加研究参与的风险或（根据研究者判断）可能使研究参与者不适合参加研究的任何医学或精神状况，包括近期（过去一年内）或主动自杀意念 / 行为或实验室检查异常。
  • •之前未入组母研究或在母研究中已终止研究治疗的研究参与者无资格参加本研究。

Outcomes

Primary Outcomes

导致永久停用 elranatamab 的非严重不良事件 (AE)

Time Frame: 首次用药至末次用药后 90 天

所有严重不良事件 (SAE)

Time Frame: 首次用药至末次用药后 90 天

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Not provided
Responsible Party
Sponsor
Principal Investigator

郭佳

Pfizer Inc./辉瑞投资有限公司/Pharmacia & Upjohn Company LLC

Study Sites (18)

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