Evaluating Study of Clinical Treatment of Multiple Myeloma Based on Analytical Omics
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Treatment toxicities:neuritis
研究概览
简要总结
With the emergence of new drugs, the short-term survival rate of multiple myeloma has been significantly increased. However, in clinical treatment, doctors found that different patients may present different clinical efficacy and adverse reactions when using standard treatment. Some studies have shown that gene and metabolic differences in patients with multiple myeloma may be an important factor affecting clinical efficacy.
In this project, peripheral blood samples and bone marrow from patients with multiple myeloma will be studied by using the methods of genomics, proteomics, metabonomics and transcriptomics. It is expected to find biomarkers and genes related to clinical efficacy, adverse reactions, and blood concentration of bortezomib in peripheral blood samples. If the sample size is large enough, the project team expects to establish a prediction model for the efficacy and safety of bortezomib containing regimen for multiple myeloma patients through the above studies. Investigators hope that the evaluation system can provide a reference for clinical formulation of appropriate drug delivery scheme.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •exposure group:
- •Patients diagnosed with multiple myeloma.
- •Patients with fluorescence in situ hybridization report results, and try to obtain genetic diagnosis results.
- •healthy control group: Patients diagnosed without multiple myeloma, such as other chronic diseases or blood tumors.
排除标准
- •Patients without complete clinical information.
- •Patients with malignant epidemic diseases.
- •Patients with alcohol abuse or special dietary habit .
- •Patients with digestive system diseases, such as inflammatory bowel disease, intestinal infectious disease or other diseases that may affect digestive system function.
- •Patients with a history of gastrointestinal operation.
- •Patients with severe renal insufficiency without regular dialysis.
- •Patients with other possibilities who has severe liver or kidney function injury without intervention.
研究组 & 干预措施
Multiple Myeloma group
In the exposure group, all patients with multiple myeloma met the inclusion and did not meet exclusion criteria, including planning for autologous stem cell transplantation or not. There is no distinction between age, gender and nationality.
干预措施: Bortezomib (Drug)
结局指标
主要结局
Treatment toxicities:neuritis
时间窗: From registration to December,2022
Confirmed responses: Strictly Complete response, sCR
时间窗: From registration to December,2022
Confirmed responses: Complete response, CR
时间窗: From registration to December,2022
Confirmed responses: Very good partial response, VGPR
时间窗: From registration to December,2022
Confirmed responses: Partial response, PR
时间窗: From registration to December,2022
Confirmed responses: Minimal remission, MR
时间窗: From registration to December,2022
Confirmed responses: Stable disease, SD
时间窗: From registration to December,2022
Progressive disease, PD
时间窗: From registration to December,2022
次要结局
- Progression-free survival(From registration to disease progression or date of death from any cause, whichever came first, assessed up to December,2022)
- Overall survival(From registration to death due to any cause, assessed up to December,2022)
研究者
Lihong Liu
professor
Beijing Chao Yang Hospital