NCT06062537进行中（未招募）不适用
Analysis of Effectiveness and Safety of Teclistamab in Relapsed and Refractory Multiple Myeloma Patients: a Collaborative Janssen - IFM Study IFM 2023-01: TEC-CARE
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 36
- 主要终点
- overall response rate (ORR) of teclistamab according to IMWG criteria
研究概览
简要总结
200 adult patients with multiple myeloma receiving teclistamb will be included. Effectiveness, safety, and condition of use of teclistamab in early access program (post-MA) will be assessed. Primary objective is the evaluation of overall response rate (ORR) of teclistamab according to IMWG criteria.
This is a multicenter, prospective, observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patient (≥18 years) with multiple myeloma who will receive at least one dose of teclistamab (first dose of the step-up dose)
排除标准
- •Patients alive at the start of the study who did not receive study information or who objected to the collection of data
- •Patients who received teclistamab as part of an interventional clinical trial
- •Patients who are initiating teclistamab as part of a current interventional clinical trial
结局指标
主要结局
overall response rate (ORR) of teclistamab according to IMWG criteria
时间窗: 24 months
ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.
overall response rate (ORR) of teclistamab according to IMWG criteria
时间窗: 6 months
ORR is defined as the proportion of subjects who achieve a PR or better according to IMWG criteria.
次要结局
- Adverse events of interest(24 months)
- Conditions of use(24 months)
- Effectiveness of teclistamab(24 months)
- Conditions of use(1 month)
研究者
研究点 (36)
Loading locations...
相似试验
进行中（未招募）
1 期
A Study of Teclistamab With Other Anticancer Therapies in Participants With Multiple MyelomaMultiple MyelomaNCT04722146Janssen Research & Development, LLC140
招募中
2 期
GMMG-HD10 / DSMM-XX / 64007957MMY2003, MajesTEC-5Multiple MyelomaNCT05695508University of Heidelberg Medical Center160
已完成
早期 1 期
Repeated HBO Therapy in Myeloma Patients Undergoing High-Dose Therapy and Auto-HCTMyelomaNCT04862676University of Rochester29
招募中
2 期
A Study of Telitacicept in Lupus NephritisLupus NephritisNCT05680480RemeGen Co., Ltd.120
已完成
4 期
A Multiple Myeloma Trial in Patients With Bone MetastasesMultiple MyelomaNCT00104104Novartis Pharmaceuticals179