Multiple MyelomaNCT05718401
The Diagnostic Pattern and Prognosis of Multiple Myeloma Patients With Myocardial Amyloidosis Were Evaluated by NMR Based Metabolomics
An observational study of Multiple Myeloma and Amyloidosis Cardiac, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
In this clinical study, a single-center retrospective cohort study was used to explore the clinical characteristics and risk factors of patients with multiple myeloma myocardial amyloidosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multiple Myeloma, Amyloidosis Cardiac
- What is being tested?
- NMR
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Dec 2024
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with multiple myeloma complicated with myocardial amyloidosis
Who may be able to join
- A patient with multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since January 1, 2018
Who cannot join
- A patient without multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since January 1, 2018
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Xian Jiaotong University
Xi’an, Shanxi, 710061
About this study
Official title: A Single-center Retrospective Cohort Clinical Study Was Used to Explore the Clinical Characteristics and Risk Factors of Patients With Multiple Myeloma Myocardial Amyloidosis. An Exploratory Study Was Conducted to Compare the Effects of Various Sublayer Factors on Patients' Survival. On This Basis, a Hierarchical Diagnostic Model for Patients With Multiple Myeloma Complicated With Myocardial Amyloidosis Was Established Based on the Phenoomics of NMR and Mass Spectrometry Were Evaluated Simultaneously
In this clinical study, a single-center retrospective cohort study was used to explore the clinical characteristics and risk factors of patients with multiple myeloma myocardial amyloidosis. An exploratory study was conducted to compare the effects of various sublayer factors (M protein, electrocardiogram, echocardiography, CD138, chromosome abnormalities, etc.) on patients' survival. On this basis, a hierarchical diagnostic model (1-2-3-4) for patients with multiple myeloma complicated with myocardial amyloidosis was established based on the phenoomics of NMR and mass spectrometry, and the prognosis was evaluated simultaneously, in order to create an early, non-invasive, sensitive and quantitative diagnostic model for multiple myeloma complicated with myocardial amyloidosis, and lay a foundation for the early application of effective treatment.
Read the detailed description
The purpose of this study was to collect clinical data of patients with multiple myeloma complicated with myocardial amyloidosis, analyze and collate the data through statistical methods, and explore the clinical characteristics of patients with MM complicated with myocardial amyloidosis, the factors that may lead to the occurrence of myocardial amyloidosis and the differences in the data of cardiac ultrasound and other biochemical tests, so as to evaluate the prognosis of patients.
To investigate the clinical features, risk factors and prognosis of patients with multiple myeloma myocardial amyloidosis. The clinical experience of diagnosis and treatment of this complication was summarized. On this basis, a standard database suitable for the northwest population was established based on NMR phenoomics, and a hierarchical diagnostic model (1-2-3-4) was explored for multiple myeloma patients with myocardial amyloidosis, and the prognosis was evaluated simultaneously. In order to establish an early, non-invasive, sensitive and quantitative diagnostic model for multiple myeloma complicated with myocardial amyloidosis, and to provide clinical basis for further research on early diagnosis, early prevention and early treatment of the disease. To provide the basis for individualized stratified prevention and treatment of patients with multiple myeloma myocardial amyloidosis, reduce the family medical burden and related side effects, improve the quality of life of patients with myeloma myocardial amyloidosis, prolong the survival period, and improve the cure rate
- Conditions
- Multiple Myeloma, Amyloidosis Cardiac
- Being tested
- NMR
- Medical subject headings
- Multiple Myeloma, Amyloid Neuropathies, Familial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMRDevice
nuclear magnetic resonance in genomics
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Patients With Multiple Myeloma Myocardial Amyloidosis Receives: Device: NMR | |
| Control group | Patients With Multiple Myeloma but without Myocardial Amyloidosis. Receives: Device: NMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
The long axial strain of echocardiography
The long axial strain of echocardiography was in the normal range（18%-22%）
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 mouths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start1 Nov 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.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liu huasheng, Ph.D, Study director, First Hospital of Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05718401
- Sponsor's protocol ID
- XJTU1AF-CRF-2022-033
- Status last verified
- Jan 2023
- First submitted
- 16 Jan 2023
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center Retrospective Cohort Clinical Study Was Used to Explore the Clinical Characteristics and Risk Factors of Patients With Multiple Myeloma Myocardial Amyloidosis. An Exploratory Study Was Conducted to Compare the Effects of Various Sublayer Factors on Patients' Survival. On This Basis, a Hierarchical Diagnostic Model for Patients With Multiple Myeloma Complicated With Myocardial Amyloidosis Was Established Based on the Phenoomics of NMR and Mass Spectrometry Were Evaluated Simultaneously
- ClinicalTrials.gov ID
- NCT05718401
- Acronym / sponsor ID
- XJTU1AF-CRF-2022-033
- Conditions
- Multiple Myeloma, Amyloidosis Cardiac
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 8 Feb 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.
In this clinical study, a single-center retrospective cohort study was used to explore the clinical characteristics and risk factors of patients with multiple myeloma myocardial amyloidosis. An exploratory study was conducted to compare the effects of various sublayer factors (M protein, electrocardiogram, echocardiography, CD138, chromosome abnormalities, etc.) on patients' survival. On this basis, a hierarchical diagnostic model (1-2-3-4) for patients with multiple myeloma complicated with myocardial amyloidosis was established based on the phenoomics of NMR and mass spectrometry, and the prognosis was evaluated simultaneously, in order to create an early, non-invasive, sensitive and quantitative diagnostic model for multiple myeloma complicated with myocardial amyloidosis, and lay a foundation for the early application of effective treatment.
Detailed description
The purpose of this study was to collect clinical data of patients with multiple myeloma complicated with myocardial amyloidosis, analyze and collate the data through statistical methods, and explore the clinical characteristics of patients with MM complicated with myocardial amyloidosis, the factors that may lead to the occurrence of myocardial amyloidosis and the differences in the data of cardiac ultrasound and other biochemical tests, so as to evaluate the prognosis of patients.
To investigate the clinical features, risk factors and prognosis of patients with multiple myeloma myocardial amyloidosis. The clinical experience of diagnosis and treatment of this complication was summarized. On this basis, a standard database suitable for the northwest population was established based on NMR phenoomics, and a hierarchical diagnostic model (1-2-3-4) was explored for multiple myeloma patients with myocardial amyloidosis, and the prognosis was evaluated simultaneously. In order to establish an early, non-invasive, sensitive and quantitative diagnostic model for multiple myeloma complicated with myocardial amyloidosis, and to provide clinical basis for further research on early diagnosis, early prevention and early treatment of the disease. To provide the basis for individualized stratified prevention and treatment of patients with multiple myeloma myocardial amyloidosis, reduce the family medical burden and related side effects, improve the quality of life of patients with myeloma myocardial amyloidosis, prolong the survival period, and improve the cure rate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Device: NMRPatients With Multiple Myeloma Myocardial Amyloidosis |
| Control group | – | Device: NMRPatients With Multiple Myeloma but without Myocardial Amyloidosis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with multiple myeloma complicated with myocardial amyloidosis
Key inclusion criteria (1 listed)
- A patient with multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since January 1, 2018
Key exclusion criteria (1 listed)
- A patient without multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since January 1, 2018
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 |
|---|---|---|
| NMRnuclear magnetic resonance in genomics | Device | Control group, Intervention group |
Primary outcome
The long axial strain of echocardiography
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 mouths
The long axial strain of echocardiography was in the normal range（18%-22%）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
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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.
Liu huasheng, Ph.D study director
First Hospital of Xi'an Jiaotong University
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 Amyloidosis Cardiac, run by First Affiliated Hospital Xi'an Jiaotong 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 8 Feb 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The long axial strain of echocardiography (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 mouths). 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 8 Feb 2023.