A Prospective Study for Chinese Newly Diagnosed Multiple Myeloma Patients Treated With Immuno-therapy in Real-world Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- treatment patterns
研究概览
简要总结
To conduct a multicenter, prospective observational cohort study to investigate first-line immunotherapy patterns and clinical outcomes in NDMM patients in China. Leveraging the extensive patient resources of China's large center for blood disorders, the investigator will recruit approximately 500 NDMM patients to establish an NDMM patient cohort. The investigator will collect data on disease characteristics, treatment patterns, and clinical outcomes through one year of clinical follow-up. Further long-term follow-up is needed to obtain survival status and causes of death, so as to provide essential evidence for optimizing and improving patients' prognosis in clinical individualized treatment.
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
- •Newly diagnosed multiple myeloma (NDMM)
- •Plan to receive first-line immunotherapy at the respective research center
- •First-line immunotherapy includes proteasome inhibitors (PI), immunomodulatory drugs (IMiDs), or anti-CD38 monoclonal antibodies, used alone or in combination with each other or with other treatments
- •Age ≥ 18 years
- •Ability to understand the purpose of the study and follow-up process
- •Willingness to provide signed and dated written informed consent
排除标准
- •- Patients who did not receive any follow-up after initial diagnosis
结局指标
主要结局
treatment patterns
时间窗: From July 2025 to July 2026
To describe the treatment patterns of Chinese NDMM patients receiving first-line immunotherapy in real-world settings.
real-world overall response rate (rwORR)
时间窗: From July 2025 to July 2026
To determine the clinical outcomes of Chinese NDMM patients receiving first-line immunotherapy in real-world settings.The real-world overall response rate (rwORR) of the entire population, as well as the rwORR of each treatment regimen.
次要结局
- MRD(July 2025-July 2027)
- Revised International Staging System (R-ISS) Stage(July 2025-July 2026)
- Serum Lactate Dehydrogenase Level(July 2025-July 2026)
- Age at Baseline(July 2025-July 2026)
- Sex(July 2025-July 2026)
- M-Protein Isotype(July 2025-July 2026)
- Gain of Chromosome 1q21 by FISH(July 2025-July 2026)
- Ultra-High-Risk Cytogenetic Abnormalities (UHRCA)(July 2025-July 2026)
研究者
Jin Lu, MD
Dr
Peking University People's Hospital