Risk-adapted Therapeutic Strategy in +1q NDMM： a Prospective, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Treatment related adverse event(TRAE)
研究概览
简要总结
This real-world, multicenter prospective clinical study is designed to apply our internationally developed prognostic scoring system to guide individualized therapy in +1q newly diagnosed multiple myeloma (NDMM), using minimal residual disease (MRD) status as the primary endpoint.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >=18, or >=65 and fit according to IMWG-FI.
- •Newly diagnosed NDMM by 2014 IMWG criteria.
- •Adequate organ function for systemic therapy.
- •Signed informed consent.
排除标准
- •Active infections requiring systemic treatment.
- •Unstable angina, NYHA class III-IV heart failure, or uncontrolled arrhythmias.
- •History of hematologic or solid tumors treated with chemo/radiotherapy within 5 years.
- •Current malignancies requiring therapy.
- •Refusal to participate.
结局指标
主要结局
Treatment related adverse event(TRAE)
时间窗: through study completion, up to 2 years
Toxicity and safety will be reported based on the adverse events, as graded by CTCAE V5 and determined by routine clinical assessments.
MRD negativity rate
时间窗: through study completion, up to 2 years
To compare MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.
Overall Survival (OS)
时间窗: through study completion, up to 2 years
OS were calculated from the time of enrollment to death or the last follow-up
sustained MRD negativity rate
时间窗: through study completion, up to 2 years
To compare sustained MRD negativity rate between low/intermediate- and high-risk +1q NDMM patients undergoing risk-adapted individualized treatment.
Progression-Free Survival (PFS)
时间窗: through study completion, up to 2 years
PFS were calculated from the enrollment to the first instance of disease progression, relapse, or death
objective response rate
时间窗: through study completion, up to 2 years
To assess the objective response rate (ORR) and depth of response based on 2016 IMWG criteria (sCR, CR, VGPR, PR).
次要结局
- The efficacy of 1q negativity patients(through study completion, up to 2 years)
- differences between MRD-negative and MRD-positive patients(through study completion, up to 2 years)
- elderly +1q NDMM patients(through study completion, up to 2 years)
- The survival of 1q negativity patients(through study completion, up to 2 years)
研究者
FengYan Jin
The First Hospital of Jilin University
The First Hospital of Jilin University