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

Affiliated Hospital of Nantong University

Status and phase: Enrolling; Phase 3

Conditions: Multiple Myeloma

Treatments: Drug: Lenalidomide; Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT05802992

2022-K043-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Experimental group

Experimental group

Description:

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

Treatment:

Drug: Colchicine

Drug: Lenalidomide

Control group

Active Comparator group

Description:

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

Treatment:

Drug: Lenalidomide