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NCT05718401 Clinical Trial

The Diagnostic Pattern and Prognosis of Multiple Myeloma Patients With Myocardial Amyloidosis Were Evaluated by NMR Based Metabolomics

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05718401
Other study ID # XJTU1AF-CRF-2022-033
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date December 31, 2024

Study information
Verified date January 2023
Source First Affiliated Hospital Xi'an Jiaotong University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 500
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: A patient with multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since January 1, 2018 Exclusion Criteria: A patient without multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since January 1, 2018

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• NMR
nuclear magnetic resonance in genomics

Locations
Country Name City State
China First Affiliated Hospital of Xian Jiaotong University Xi'an Shanxi

Sponsors (1)
Lead Sponsor Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary The long axial strain of echocardiography The long axial strain of echocardiography was in the normal range(18%-22%) 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
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