Multiple MyelomaPhase 3NCT05802992
The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients
A Phase 3 study testing Colchicine and Lenalidomide in people with Multiple Myeloma, run by Affiliated Hospital of Nantong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Colchicine and Lenalidomide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2022to 31 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of multiple myeloma Have received at least one-line treatment Must be able to swallow tablets
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Nantong University
Nantong, Jiangsu, 226001
Hongming Huang, PhD, +8615006281688, hhmmmc@163.com
About this study
Official title: A Single-center Clinical Trial to Evaluate the Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Colchicine, Lenalidomide
- Keywords
- Multiple Myeloma, Colchicine
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
Also called Lenalidomide, Dexamethasone
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.
LenalidomideDrug
Also called Dexamethasone
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients will be treated with colchicine, lenalidomide and dexamethasone, every 28 days as a cycle. Receives: Drug: Colchicine; Drug: Lenalidomide |
| Control group | Active comparator | Patients will receive lenalidomide and dexamethasone as background treatment, every 28 days as a cycle. Receives: Drug: Lenalidomide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum M protein
Changes of the level of Serum M protein before and after treatment
Measured: [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
Measured: [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
Measured: [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
Measured: [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）
Changes of the level of Serum M protein before and after treatment
Measured: [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)
Changes of the level of CBC before and after treatment
Measured: [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
Changes of the level of Serum M protein before and after treatment
Measured: [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
Changes of the ECOG score before and after treatment.
Measured: [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]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2023
- Study start30 Mar 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongming Huang, Affiliated Hospital of Nantong University
- Investigators
- Hongming Huang, PhD, Study director, Affiliated Hospital of Nantong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05802992
- Sponsor's protocol ID
- 2022-K043-01
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not planning sharing at present.
Publications
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.
PubMed 28832953Cho 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.
PubMed 29061810Zhang 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.
PubMed 30429232Bell 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.
PubMed 34838691Livneh 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.
PubMed 8122124JYO 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.
PubMed 13791163Urbaniak 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.
PubMed 32141170
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Clinical Trial to Evaluate the Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients
- ClinicalTrials.gov ID
- NCT05802992
- Acronym / sponsor ID
- 2022-K043-01
- Conditions
- Multiple Myeloma
- Keywords
- Multiple Myeloma, Colchicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Colchicine, Drug: LenalidomidePatients will be treated with colchicine, lenalidomide and dexamethasone, every 28 days as a cycle. |
| Control group | Active comparator | Drug: LenalidomidePatients will receive lenalidomide and dexamethasone as background treatment, every 28 days as a cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical diagnosis of multiple myeloma Have received at least one-line treatment Must be able to swallow tablets
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColchicineAlso: Lenalidomide, DexamethasoneThe 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. | Drug | Experimental group |
| LenalidomideAlso: DexamethasoneIn 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. | Drug | Control group, Experimental group |
Primary outcome
Serum M protein
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]
Changes of the level of Serum M protein before and after treatment
Proportion of bone marrow plasma cells
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]
Changes of the proportion of bone marrow plasma cells before and after treatment
Serum protein electrophoresis (SPEP) and urine protein electrophoresis (UPEP）
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]
Changes of the level of SPEP and UPEP before and after treatment
Serum free light chain (FLC)
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]
Changes of the level of Serum FLC before and after treatment
4 secondary outcomes
Imaging（X ray/CT/MRI）
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]
Complete blood count (CBC)
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]
Blood biochemistries
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]
Eastern Cooperative Oncology Group (ECOG) Score
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]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Background: PubMed 28832953Dasgeb 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.
- Background: PubMed 29061810Cho 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.
- Background: PubMed 30429232Zhang 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.
- Background: PubMed 34838691Bell 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.
- Background: PubMed 8122124Livneh 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.
- Background: PubMed 13791163JYO 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.
- Background: PubMed 32141170Urbaniak 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.
- Individual participant dataSharing planned: No. Not planning sharing at present.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongming Huang, PhD study director
Affiliated Hospital of Nantong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Colchicine and Lenalidomide in people with Multiple Myeloma, run by Affiliated Hospital of Nantong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongming Huang, PhD (+8615006281688, hhmmmc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum M protein (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]). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05802992, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.