The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients

Multiple Myeloma Clinical Trial

Official title:

A Single-center Clinical Trial to Evaluate the Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05802992
• Other study ID #: 2022-K043-01
• Status: Recruiting
• Phase: Phase 3
• Start date: March 30, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Affiliated Hospital of Nantong University
• Contact: Hongming Huang, PhD
• Phone: +8615006281688
• Email: hhmmmc[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Drug:
• Colchicine
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.
• Lenalidomide
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.

Locations

Country	Name	City	State
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum M protein	Changes of the level of Serum M protein before and after treatment	[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]
Primary	Proportion of bone marrow plasma cells	Changes of the proportion of bone marrow plasma cells before and after treatment	[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]
Primary	Serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP)	Changes of the level of SPEP and UPEP before and after treatment	[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]
Primary	Serum free light chain (FLC)	Changes of the level of Serum FLC before and after treatment	[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	Imaging(X ray/CT/MRI)	Changes of the level of Serum M protein before and after treatment	[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]
Secondary	Complete blood count (CBC)	Changes of the level of CBC before and after treatment	[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	Blood biochemistries	Changes of the level of Serum M protein before and after treatment	[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	Eastern Cooperative Oncology Group (ECOG) Score	Changes of the ECOG score before and after treatment.	[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]