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Trial Title:
The Efficacy and Safety of Colchicine Combined With Conventional Therapy in Multiple Myeloma Patients
NCT ID:
NCT05802992
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Dexamethasone acetate
Lenalidomide
Colchicine
BB 1101
Conditions: Keywords:
Multiple Myeloma
Colchicine
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Colchicine
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.
Arm group label:
Experimental group
Other name:
Lenalidomide
Other name:
Dexamethasone
Intervention type:
Drug
Intervention name:
Lenalidomide
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.
Arm group label:
Control group
Arm group label:
Experimental group
Other name:
Dexamethasone
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Affiliated Hospital of Nantong University
Address:
City:
Nantong
Zip:
226001
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongming Huang, PhD
Phone:
+8615006281688
Email:
hhmmmc@163.com
Start date:
March 30, 2022
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Affiliated Hospital of Nantong University
Agency class:
Other
Source:
Affiliated Hospital of Nantong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05802992
