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

NCT05802992 | Unknown Phase 3 DMC

• 1 other identifier: 2022-K043-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

Multiple Myeloma; Colchicine

Outcome Measures

Primary Outcomes (4)

• 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]

• 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]

• 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]

• 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 Outcomes (4)

• 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]

• 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]

• 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]

• 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]

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients will be treated with colchicine, lenalidomide and dexamethasone, every 28 days as a cycle.

Drug: Colchicine; Drug: Lenalidomide

Control group

ACTIVE COMPARATOR

Patients will receive lenalidomide and dexamethasone as background treatment, every 28 days as a cycle.

Drug: Lenalidomide

Interventions

Colchicine DRUG

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.

Also known as: Lenalidomide, Dexamethasone

Experimental group

Lenalidomide DRUG

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.

Also known as: Dexamethasone

Control group; Experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of multiple myeloma Have received at least one-line treatment Must be able to swallow tablets

You may not qualify if:

• 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

Sponsors & Collaborators

• Affiliated Hospital of Nantong University: lead

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

RECRUITING

Related Publications (7)

• 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.

  PMID: 28832953 BACKGROUND

• 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.

  PMID: 29061810 BACKGROUND

• 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.

  PMID: 30429232 BACKGROUND

• 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.

  PMID: 34838691 BACKGROUND

• 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.

  PMID: 8122124 BACKGROUND

• 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.

  PMID: 13791163 BACKGROUND

• 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.

  PMID: 32141170 BACKGROUND

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Colchicine; Lenalidomide; Dexamethasone

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hongming Huang, PhD

  Affiliated Hospital of Nantong University

  STUDY DIRECTOR

Central Study Contacts

Hongming Huang, PhD

CONTACT

+8615006281688; hhmmmc@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Director of Hematology Department

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: April 7, 2023
• Study Start: March 30, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 7, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)