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

NCT05718401 | Unknown FDA Device

• 1 other identifier: XJTU1AF-CRF-2022-033
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Myeloma; Amyloidosis Cardiac

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Intervention group

Patients With Multiple Myeloma Myocardial Amyloidosis

Device: NMR

Control group

Patients With Multiple Myeloma but without Myocardial Amyloidosis.

Device: NMR

Interventions

NMR DEVICE

nuclear magnetic resonance in genomics

Control group; Intervention group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with multiple myeloma complicated with myocardial amyloidosis

You may qualify if:

• A patient with multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since January 1, 2018

You may not qualify if:

• A patient without multiple myeloma complicated with myocardial amyloidosis was diagnosed in our hospital since January 1, 2018

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First Affiliated Hospital of Xian Jiaotong University

Xi’an, Shanxi, 710061, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood or/and urine

MeSH Terms

Conditions

Multiple Myeloma; Amyloid Neuropathies, Familial

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Nervous System Diseases; Amyloid Neuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Amyloidosis, Familial; Metabolism, Inborn Errors; Metabolic Diseases; Nutritional and Metabolic Diseases; Amyloidosis; Proteostasis Deficiencies

Study Officials

• Liu huasheng, Ph.D

  First Hospital of Xi'an Jiaotong University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: February 8, 2023
• Study Start: November 1, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-01

Locations

CN (1)