A Single-center Clinical Trial to Evaluate the Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP）
研究概览
简要总结
To evaluate the efficacy and safety of investigational drug Colchicine combined with conventional lenalidomide based therapy in multiple myeloma subjects who had received first-line therapy (including Chimeric antigen receptor T-Cell immunotherapy (CART) treatment), and to evaluate the quality of life of the patients.
详细描述
This study is expected to be carried out from March 2022 to December 2024. About 30 patients with multiple myeloma who have received at least first-line of treatment (including Chimeric antigen receptor T-Cell immunotherapy (CART) treatment) will be randomly assigned to the experimental group or the control group at 2:1. By comparing the relevant data such as efficacy evaluation and safety evaluation after treatment, the principal investigator will write and publish the paper.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of multiple myeloma Have received at least one-line treatment Must be able to swallow tablets
排除标准
- •Resistance to or intolerance to therapeutic agents such as bortezomib or lenalidomide Allergy to the experimental drug or its ingredients Has invaded the central nervous system Severe cardiovascular, liver and kidney failure, severe chronic obstructive pulmonary disease (COPD), and moderate to severe asthma Active hepatitis B or C infection HIV seropositivity Is participating in other clinical trials or has participated in other clinical trials within the past two weeks Other factors that the researchers determined were not suitable for the trial
研究组 & 干预措施
Experimental group
Patients will be treated with colchicine, lenalidomide and dexamethasone, every 28 days as a cycle.
干预措施: Colchicine (Drug)
Experimental group
Patients will be treated with colchicine, lenalidomide and dexamethasone, every 28 days as a cycle.
干预措施: Lenalidomide (Drug)
Control group
Patients will receive lenalidomide and dexamethasone as background treatment, every 28 days as a cycle.
干预措施: Lenalidomide (Drug)
结局指标
主要结局
Serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP）
时间窗: [Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
Changes of the level of SPEP and UPEP before and after treatment
Serum M protein
时间窗: [Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
Changes of the level of Serum M protein before and after treatment
Proportion of bone marrow plasma cells
时间窗: [Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
Changes of the proportion of bone marrow plasma cells before and after treatment
Serum free light chain (FLC)
时间窗: [Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months]
Changes of the level of Serum FLC before and after treatment
次要结局
- Complete blood count (CBC)([Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months])
- Eastern Cooperative Oncology Group (ECOG) Score([Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months])
- Imaging（X ray/CT/MRI）([Time Frame:Baseline, at the end of every two cycles (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months])
- Blood biochemistries([Time Frame:Baseline, at the end of each cycle (each cycle is 35 days). From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months])
研究者
Hongming Huang
Deputy Director of Hematology Department
Affiliated Hospital of Nantong University