Prospective Observational Study on the Clinical Efficacy of Teclistamab in Patients with Relapsed and Refractory Multiple Myeloma in Belgium
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 17
- 主要终点
- Overall response rate
研究概览
简要总结
The aim of this study is to assess the clinical efficacy and safety of the anti-BCMA/CD3 bispecific antibody teclistamab (Tecvayli®) in a prospective, real-life setting in Belgium.
详细描述
To assess the clinical efficacy and safety of teclistamab (Tecvayli®) in relapsed/refractory multiple myeloma patients who have received at least 3 prior lines of treatment and who will receive teclistamab (Tecvayli®) as the next treatment. Patients will be followed up prospectively until the end of study (24 months/2 years), or until disease progression, withdrawal of consent death or loss to follow-up, whichever occurs first. Each patient will have a monthly follow-up from baseline until 6 months of treatment with teclistamab. Then, data will be collected every 3 months until the end of 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
- •age 18 years or older
- •written informed consent
- •has a diagnosis of relapsed and refractory multiple myeloma
- •received at least three prior lines of therapy
- •is refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-CD38 monoclonal antibody
- •evidence of disease progression on the last line of therapy, based on determination of response by the IMWG response criteria
- •anticipated to start treatment with teclistamab per routine clinical care or has started with teclistamab treatment ≤14 days before intended screening visit
排除标准
- •Has participated in a teclistamab trial (teclistamab or control arm) or teclistamab Single Patient Request (SPR) program
- •Has started teclistamab treatment >14 days before intended screening visit.
研究组 & 干预措施
Relapsed or refractory multiple myeloma patients
Patients aged 18 years or older diagnosed with relapsed or refractory multiple myeloma, who received at least 3 prior lines of treatment. They should be refractory to at least 1 proteasome inhibitor, at least 1 immunomodulatory agent, and an anti-CD38 monoclonal antibody. After confirmation of disease progression, the patients will start treatment with teclistamab per routine clinical care or will have started with teclistamab treatment ≤14 days before intended screening visit
干预措施: Teclistamab (Drug)
结局指标
主要结局
Overall response rate
时间窗: At baseline, monthly until end of study (maximum 24 months)
The primary objective is the overall response rate (partial response (PR) or better) according to the 2016 IMWG response criteria of Multiple myeloma.
次要结局
- Overall survival (OS)(At baseline, monthly until end of study (maximum 24 months))
- Depth of response(At baseline, monthly until end of study (maximum 24 months))
- Duration of response(At baseline, monthly until end of study (maximum 24 months))
- Time to next treatment (TTNT)(At baseline, monthly until end of study (maximum 24 months))
- Incidence of (serious) adverse events(At baseline, monthly until end of study (maximum 24 months))
- Progression-free survival (PFS)(At baseline, monthly until end of study (maximum 24 months))
- Time to response (TTR)(At baseline, monthly until end of study (maximum 24 months))
- Minimal Residual Disease (MRD) assessment(At suspected CR, every 6 months thereafter until end of study (maximum 24 months))