Multiple MyelomaNCT06539832
Intestinal Flora and Immunity in Monoclonal Gammopathy Patients
An observational study of Multiple Myeloma and MGUS, run by Zhujiang Hospital at 1 site in China.
Trial summary
This study aims to investigate the characteristics of the gut microbiota and immune function status in patients with monoclonal gammopathy complicated by infection, and to analyze the correlation between the two.200 patients diagnosed with monoclonal gammopathy by MALDI-TOF MS were included, of which 100 had… Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, MGUS, Gut Microbiota
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2024to 30 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will consist of patients aged 45 years and older who meet the following inclusion criteria: 1. Monoclonal gammopathy negative as determined by MALDI-TOF MS screening. 2. No symptoms of infection and normal levels of inflammatory markers (whole blood hs-CRP, serum IL-6, PCT). 3. Availability of sufficient remaining whole blood, plasma and fecal samples, as well as relevant case information. Patients will be excluded if they have: 1. A previous history of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease. 2. Received antibiotic therapy within the last month. 3. Severe systemic diseases, including malignant tumors. Insufficient sample volume or presence of sample failure (e.g. severe hemolysis, lipemia or jaundice).
Who may be able to join
- Age 45 years and older; and
- Patients who were monoclonal gammaglobulin negative by MALDI-TOF MS screening;
- No symptoms of infection and normal indicators of infection (whole blood hs-CRP, serum IL-6, PCT);
- Sufficient remaining whole blood, plasma and faecal samples are available, and relevant case information can be provided.
Who cannot join
- Those with a previous history of intestinal tumour, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital; and
- Patients receiving antibiotic therapy in the last month
- Severe systemic diseases including malignant tumours;
- Insufficient remaining sample volume, or the presence of sample failure such as severe haemolysis, lipaemia or jaundice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hongwei Zhou, Professor contact
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guanzhou, Guangdong, 510280
Hongwei Zhou, Professor, 186 8848 9622, hzhou@smu.edu.cn
About this study
Official title: Correlation Analysis of Intestinal Flora and Immune Function in Patients With Monoclonal Immunoglobulinaemia Co-infection
This study aims to investigate the characteristics of the gut microbiota and immune function status in patients with monoclonal gammopathy complicated by infection, and to analyze the correlation between the two.200 patients diagnosed with monoclonal gammopathy by MALDI-TOF MS were included, of which 100 had concurrent infections and 100 did not. An additional 100 healthy controls, matched for age and gender, were also enrolled.By comparing the composition of the gut microbiota and immune function markers (such as peripheral blood immune cell profiles and cytokine levels) between the patient groups and the control group, the study will evaluate the dysbiosis of the gut microbiota and abnormal immune status in patients with monoclonal gammopathy complicated by infection. The aim is to explore the correlation between the gut microbiome alterations and immune dysfunction, in order to provide a basis for further investigation of the underlying mechanisms.
Read the detailed description
The intestine is the largest immune organ in the human body, playing a crucial role in regulating host health, maintaining metabolic and immune homeostasis, and preventing pathogen invasion. The gut microbiota can directly participate in the immune regulation of the host, promote the development of the immune system, and maintain normal immune function. Meanwhile, the immune system also has a regulatory and constraining effect on the gut microbiota. With age, the structure of the gut microbiota and the function of the immune system undergo continuous changes and adjustments to adapt to the body's needs. This dynamic gut microbiota-immune system interaction plays a key role in maintaining metabolic homeostasis and immune balance in the body.Multiple myeloma (MM) is a hematological malignancy characterized by the clonal proliferation of malignant plasma cells in the bone marrow, commonly seen in middle-aged and elderly individuals. MM patients generally have a higher risk of infection, especially after receiving intensive chemotherapy or hematopoietic stem cell transplantation.Monoclonal gammopathy of undetermined significance (MGUS) is an asymptomatic condition, and multiple myeloma often progresses from monoclonal gammopathy. Although most MGUS patients do not progress to malignant disease for life, MGUS patients do have a higher risk of infection. Gut microbiome dysbiosis may be involved in regulating immune function, leading to increased susceptibility to infections in MGUS patients.This study aims to use a retrospective cohort study approach to systematically analyze the characteristics of the gut microbiota in MGUS patients with concurrent infections, and explore its correlation with immune-related indicators. In-depth analysis of these key factors will help further elucidate the pathogenesis of MGUS complicated by infection, and provide new evidence and insights for clinical prevention and treatment.
- Conditions
- Multiple Myeloma, MGUS, Gut Microbiota, Infections, M-Protein
- Medical subject headings
- Multiple Myeloma, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Monoclonal gammopathy patients without concurrent infection | (I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened positive for monoclonal protein by MALDI-TOF MS; 3. No symptoms of infection, with normal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma and stool samples available, and relevant case data can be provided. (II) Exclusion criteria: 1. History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease, or diagnosed during hospitalization; 2. Received antibiotic treatment in the past one month; 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions. | |
| Monoclonal gammopathy patients with concurrent infection | (I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened positive for monoclonal protein by MALDI-TOF MS; 3. Presence of infection symptoms, with abnormal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma and stool samples available, and relevant case data can be provided. (II) Exclusion criteria: 1. History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease, or diagnosed during hospitalization; 2. Received antibiotic treatment in the past one month; 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions. | |
| Healthy control group | (I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened negative for monoclonal protein by MALDI-TOF MS; 3. No symptoms of infection, with normal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma and stool samples available, and relevant case data can be provided. (II) Exclusion criteria: 1. History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease, or diagnosed during hospitalization; 2. Received antibiotic treatment in the past one month; 3. Severe systemic diseases including malignant tumors; 4. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
M-protein detection
Plasma samples from all patients will be screened and qualitatively analysed for M proteins using MALDI-TOF MS to determine the presence of patients with monoclonal gammaglobulinemia.
Measured: 24 months
microbiome
To assess the value of the microbiome in predicting the prognosis of patients with monoclonal gammopathy and in diagnosing co-morbidities. To analyse the microbial composition of patient stool samples using 16S rRNA gene sequencing and metagenomics.
Measured: 24 months
immunological function
To assess the number and function of peripheral blood immune cells (T-cells, B-cells, NK-cells, etc.) in patients with monoclonal gammaglobulinaemia. To further investigate the potential therapeutic value of intestinal microecological modulation in improving the immune status of MGUS patients.
Measured: 24 months
metabonomics
To assess changes in plasma metabolomics in patients with monoclonal gammaglobulinaemia. Metabolomics is a large-scale study of small molecules such as fatty acids, bile acids, and lipid mediators.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start1 May 2024
- Primary completion30 May 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongwei Zhou, Professor, Study chair, Southern Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539832
- Sponsor's protocol ID
- ZhujiangMGUS
- Status last verified
- May 2024
- First submitted
- 22 Jul 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis of Intestinal Flora and Immune Function in Patients With Monoclonal Immunoglobulinaemia Co-infection
- ClinicalTrials.gov ID
- NCT06539832
- Acronym / sponsor ID
- ZhujiangMGUS
- Conditions
- Multiple Myeloma, MGUS, Gut Microbiota, Infections, M-Protein
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 6 Aug 2024 (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.
This study aims to investigate the characteristics of the gut microbiota and immune function status in patients with monoclonal gammopathy complicated by infection, and to analyze the correlation between the two.200 patients diagnosed with monoclonal gammopathy by MALDI-TOF MS were included, of which 100 had concurrent infections and 100 did not. An additional 100 healthy controls, matched for age and gender, were also enrolled.By comparing the composition of the gut microbiota and immune function markers (such as peripheral blood immune cell profiles and cytokine levels) between the patient groups and the control group, the study will evaluate the dysbiosis of the gut microbiota and abnormal immune status in patients with monoclonal gammopathy complicated by infection. The aim is to explore the correlation between the gut microbiome alterations and immune dysfunction, in order to provide a basis for further investigation of the underlying mechanisms.
Detailed description
The intestine is the largest immune organ in the human body, playing a crucial role in regulating host health, maintaining metabolic and immune homeostasis, and preventing pathogen invasion. The gut microbiota can directly participate in the immune regulation of the host, promote the development of the immune system, and maintain normal immune function. Meanwhile, the immune system also has a regulatory and constraining effect on the gut microbiota. With age, the structure of the gut microbiota and the function of the immune system undergo continuous changes and adjustments to adapt to the body's needs. This dynamic gut microbiota-immune system interaction plays a key role in maintaining metabolic homeostasis and immune balance in the body.Multiple myeloma (MM) is a hematological malignancy characterized by the clonal proliferation of malignant plasma cells in the bone marrow, commonly seen in middle-aged and elderly individuals. MM patients generally have a higher risk of infection, especially after receiving intensive chemotherapy or hematopoietic stem cell transplantation.Monoclonal gammopathy of undetermined significance (MGUS) is an asymptomatic condition, and multiple myeloma often progresses from monoclonal gammopathy. Although most MGUS patients do not progress to malignant disease for life, MGUS patients do have a higher risk of infection. Gut microbiome dysbiosis may be involved in regulating immune function, leading to increased susceptibility to infections in MGUS patients.This study aims to use a retrospective cohort study approach to systematically analyze the characteristics of the gut microbiota in MGUS patients with concurrent infections, and explore its correlation with immune-related indicators. In-depth analysis of these key factors will help further elucidate the pathogenesis of MGUS complicated by infection, and provide new evidence and insights for clinical prevention and treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monoclonal gammopathy patients without concurrent infection | – | –(I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened positive for monoclonal protein by MALDI-TOF MS; 3. No symptoms of infection, with normal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma and stool samples available, and relevant case data can be provided. (II) Exclusion criteria: 1. History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease, or diagnosed during hospitalization; 2. Received antibiotic treatment in the past one month; 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions. |
| Monoclonal gammopathy patients with concurrent infection | – | –(I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened positive for monoclonal protein by MALDI-TOF MS; 3. Presence of infection symptoms, with abnormal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma and stool samples available, and relevant case data can be provided. (II) Exclusion criteria: 1. History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease, or diagnosed during hospitalization; 2. Received antibiotic treatment in the past one month; 3. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions. |
| Healthy control group | – | –(I) Inclusion criteria: 1. Age 45 years or older; 2. Patients screened negative for monoclonal protein by MALDI-TOF MS; 3. No symptoms of infection, with normal infection indicators (whole blood hs-CRP, serum IL-6, PCT); 4. Adequate remaining whole blood, plasma and stool samples available, and relevant case data can be provided. (II) Exclusion criteria: 1. History of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease, or diagnosed during hospitalization; 2. Received antibiotic treatment in the past one month; 3. Severe systemic diseases including malignant tumors; 4. Insufficient sample volume, or presence of severe hemolysis, lipemia, jaundice or other unqualified sample conditions. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients aged 45 years and older who meet the following inclusion criteria: 1. Monoclonal gammopathy negative as determined by MALDI-TOF MS screening. 2. No symptoms of infection and normal levels of inflammatory markers (whole blood hs-CRP, serum IL-6, PCT). 3. Availability of sufficient remaining whole blood, plasma and fecal samples, as well as relevant case information. Patients will be excluded if they have: 1. A previous history of intestinal tumors, irritable bowel syndrome or inflammatory bowel disease. 2. Received antibiotic therapy within the last month. 3. Severe systemic diseases, including malignant tumors. Insufficient sample volume or presence of sample failure (e.g. severe hemolysis, lipemia or jaundice).
Key inclusion criteria (4 listed)
- Age 45 years and older; and
- Patients who were monoclonal gammaglobulin negative by MALDI-TOF MS screening;
- No symptoms of infection and normal indicators of infection (whole blood hs-CRP, serum IL-6, PCT);
- Sufficient remaining whole blood, plasma and faecal samples are available, and relevant case information can be provided.
Key exclusion criteria (4 listed)
- Those with a previous history of intestinal tumour, irritable bowel syndrome or inflammatory bowel disease or confirmed in hospital; and
- Patients receiving antibiotic therapy in the last month
- Severe systemic diseases including malignant tumours;
- Insufficient remaining sample volume, or the presence of sample failure such as severe haemolysis, lipaemia or jaundice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
M-protein detection
Time frame: 24 months
Plasma samples from all patients will be screened and qualitatively analysed for M proteins using MALDI-TOF MS to determine the presence of patients with monoclonal gammaglobulinemia.
microbiome
Time frame: 24 months
To assess the value of the microbiome in predicting the prognosis of patients with monoclonal gammopathy and in diagnosing co-morbidities. To analyse the microbial composition of patient stool samples using 16S rRNA gene sequencing and metagenomics.
immunological function
Time frame: 24 months
To assess the number and function of peripheral blood immune cells (T-cells, B-cells, NK-cells, etc.) in patients with monoclonal gammaglobulinaemia. To further investigate the potential therapeutic value of intestinal microecological modulation in improving the immune status of MGUS patients.
metabonomics
Time frame: 24 months
To assess changes in plasma metabolomics in patients with monoclonal gammaglobulinaemia. Metabolomics is a large-scale study of small molecules such as fatty acids, bile acids, and lipid mediators.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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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.
Hongwei Zhou, Professor contact
Hongwei Zhou, Professor study chair
Southern Medical University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and MGUS, run by Zhujiang Hospital 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 19 Sep 2024. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nianyi Zeng (13928801657 ext. +86, zengny1@i.smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
M-protein detection (time frame: 24 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?
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 19 Sep 2024.