The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients
- Registration Number
- NCT05802992
- Lead Sponsor
- Affiliated Hospital of Nantong University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
Clinical diagnosis of multiple myeloma Have received at least one-line treatment Must be able to swallow tablets
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental group Colchicine Patients will be treated with colchicine, lenalidomide and dexamethasone, every 28 days as a cycle. Experimental group Lenalidomide Patients will be treated with colchicine, lenalidomide and dexamethasone, every 28 days as a cycle. Control group Lenalidomide Patients will receive lenalidomide and dexamethasone as background treatment, every 28 days as a cycle.
- Primary Outcome Measures
Name Time Method Serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP） [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 [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 [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) [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
- Secondary Outcome Measures
Name Time Method 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] Changes of the level of CBC before and after treatment
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] Changes of the ECOG score before and after treatment.
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] Changes of the level of Serum M protein before and after treatment
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] Changes of the level of Serum M protein before and after treatment
Trial Locations
- Locations (1)
Affiliated Hospital of Nantong University
🇨🇳Nantong, Jiangsu, China