Back to resultsThe Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients
Primary Purpose
Multiple Myeloma
Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Colchicine
Lenalidomide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma focused on measuring Multiple Myeloma, Colchicine
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of multiple myeloma Have received at least one-line treatment Must be able to swallow tablets Exclusion Criteria: 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
Sites / Locations
- Affiliated Hospital of Nantong UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Patients will be treated with colchicine, lenalidomide and dexamethasone, every 28 days as a cycle.
Patients will receive lenalidomide and dexamethasone as background treatment, every 28 days as a cycle.
Outcomes
Primary Outcome Measures
Serum M protein
Changes of the level of Serum M protein before and after treatment
Proportion of bone marrow plasma cells
Changes of the proportion of bone marrow plasma cells before and after treatment
Serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP）
Changes of the level of SPEP and UPEP before and after treatment
Serum free light chain (FLC)
Changes of the level of Serum FLC before and after treatment
Secondary Outcome Measures
Imaging（X ray/CT/MRI）
Changes of the level of Serum M protein before and after treatment
Complete blood count (CBC)
Changes of the level of CBC before and after treatment
Blood biochemistries
Changes of the level of Serum M protein before and after treatment
Eastern Cooperative Oncology Group (ECOG) Score
Changes of the ECOG score before and after treatment.
Full Information
NCT ID
NCT05802992
First Posted
March 3, 2023
Last Updated
March 25, 2023
Sponsor
Affiliated Hospital of Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT05802992
Brief Title
The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients
Official Title
A Single-center Clinical Trial to Evaluate the Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Affiliated Hospital of Nantong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
Multiple Myeloma, Colchicine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients will be treated with colchicine, lenalidomide and dexamethasone, every 28 days as a cycle.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients will receive lenalidomide and dexamethasone as background treatment, every 28 days as a cycle.
Intervention Type
Drug
Intervention Name(s)
Colchicine
Other Intervention Name(s)
Lenalidomide, Dexamethasone
Intervention Description
The investigational drug colchicine was used at a daily dose of 0.5-1 mg. In every cycle, lenalidomide was administered at 10-25 mg (days 1-21). Dexamethasone 40mg (≤75 years old) or 20mg (>75 years old) per week.If the weekly dose of dexamethasone is 40mg, it should be taken in the first two days of the week, 20mg per day; If the weekly dose is 20mg or take the lower dose on the first day of each week.
If the patient needs to be treated with the investigational drug colchicine on the day of dexamethasone administration, he should take dexamethasone orally within 3 hours before the administration of colchicine.
Intervention Type
Drug
Intervention Name(s)
Lenalidomide
Other Intervention Name(s)
Dexamethasone
Intervention Description
In every cycle, lenalidomide was administered at 10-25 mg (days 1-21). Dexamethasone 40mg (≤75 years old) or 20mg (>75 years old) per week.If the weekly dose of dexamethasone is 40mg, it should be taken in the first two days of the week, 20mg per day; If the weekly dose is 20mg or take the lower dose on the first day of each week.
Primary Outcome Measure Information:
Title
Serum M protein
Description
Changes of the level of Serum M protein before and after treatment
Time Frame
[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]
Title
Proportion of bone marrow plasma cells
Description
Changes of the proportion of bone marrow plasma cells before and after treatment
Time Frame
[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]
Title
Serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP）
Description
Changes of the level of SPEP and UPEP before and after treatment
Time Frame
[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]
Title
Serum free light chain (FLC)
Description
Changes of the level of Serum FLC before and after treatment
Time Frame
[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]
Secondary Outcome Measure Information:
Title
Imaging（X ray/CT/MRI）
Description
Changes of the level of Serum M protein before and after treatment
Time Frame
[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]
Title
Complete blood count (CBC)
Description
Changes of the level of CBC before and after treatment
Time Frame
[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]
Title
Blood biochemistries
Description
Changes of the level of Serum M protein before and after treatment
Time Frame
[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]
Title
Eastern Cooperative Oncology Group (ECOG) Score
Description
Changes of the ECOG score before and after treatment.
Time Frame
[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]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of multiple myeloma Have received at least one-line treatment Must be able to swallow tablets
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongming Huang, PhD
Phone
+8615006281688
Email
hhmmmc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongming Huang, PhD
Organizational Affiliation
Affiliated Hospital of Nantong University
Official's Role
Study Director
Facility Information:
Facility Name
Affiliated Hospital of Nantong University
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongming Huang, PhD
Phone
+8615006281688
Email
hhmmmc@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Not planning sharing at present.
Citations:
PubMed Identifier
28832953
Citation
Dasgeb B, Kornreich D, McGuinn K, Okon L, Brownell I, Sackett DL. Colchicine: an ancient drug with novel applications. Br J Dermatol. 2018 Feb;178(2):350-356. doi: 10.1111/bjd.15896. Epub 2018 Jan 3.
Results Reference
background
PubMed Identifier
29061810
Citation
Cho JH, Joo YH, Shin EY, Park EJ, Kim MS. Anticancer Effects of Colchicine on Hypopharyngeal Cancer. Anticancer Res. 2017 Nov;37(11):6269-6280. doi: 10.21873/anticanres.12078.
Results Reference
background
PubMed Identifier
30429232
Citation
Zhang T, Chen W, Jiang X, Liu L, Wei K, Du H, Wang H, Li J. Anticancer effects and underlying mechanism of Colchicine on human gastric cancer cell lines in vitro and in vivo. Biosci Rep. 2019 Jan 15;39(1):BSR20181802. doi: 10.1042/BSR20181802. Print 2019 Jan 31.
Results Reference
background
PubMed Identifier
34838691
Citation
Bell CJ, Potts KG, Hitt MM, Pink D, Tuszynski JA, Lewis JD. Novel colchicine derivative CR42-24 demonstrates potent anti-tumor activity in urothelial carcinoma. Cancer Lett. 2022 Feb 1;526:168-179. doi: 10.1016/j.canlet.2021.11.028. Epub 2021 Nov 25.
Results Reference
background
PubMed Identifier
8122124
Citation
Livneh A, Zemer D, Langevitz P, Shemer J, Sohar E, Pras M. Colchicine in the treatment of AA and AL amyloidosis. Semin Arthritis Rheum. 1993 Dec;23(3):206-14. doi: 10.1016/s0049-0172(05)80042-3.
Results Reference
background
PubMed Identifier
13791163
Citation
JYO T, ENDOH H. [Clinical experience with Colcemid in true polycythemia and chronic myelogenic leukemia]. Naika Hokan. 1961 Jul 20;8:607-15. No abstract available. Japanese.
Results Reference
background
PubMed Identifier
32141170
Citation
Urbaniak A, Jousheghany F, Pina-Oviedo S, Yuan Y, Majcher-Uchanska U, Klejborowska G, Moorjani A, Monzavi-Karbassi B, Huczynski A, Chambers TC. Carbamate derivatives of colchicine show potent activity towards primary acute lymphoblastic leukemia and primary breast cancer cells-in vitro and ex vivo study. J Biochem Mol Toxicol. 2020 Jun;34(6):e22487. doi: 10.1002/jbt.22487. Epub 2020 Mar 5.
Results Reference
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The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients
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