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Multiple Myeloma

Neoplasms, Plasma Cell

Amyloidosis

Neoplasms by Histologic Type

Hemostatic Disorders

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Paraproteinemias

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Immunoproliferative Disorders

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Metabolic Diseases

Patients With Multiple Myeloma Myocardial Amyloidosis

Patients With Multiple Myeloma but without Myocardial Amyloidosis.

Liu huasheng, Ph.D

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.

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

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

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

The long axial strain of echocardiography was in the normal range（18%-22%）

First Affiliated Hospital Xi'an Jiaotong University

Cardiomyopathies

Immunoglobulin Light-chain Amyloidosis

Heart Diseases

AL Amyloidosis

Participants in this cohort are individuals undergoing clinically indicated cardiac device implantation, such as pacemakers, ICDs, ILRs, or CRT-D/Ps. During the standard implantation procedure, chest wall fat tissue typically excised to create space for the device is collected for histopathological analysis to identify amyloid deposits. This study involves no additional intervention beyond the routine clinical care received by the patients.

As part of routine cardiac device implantation, chest wall fat tissue is collected for histopathological analysis. This tissue, which is typically discarded, will be used to identify amyloid deposits in high-risk cardiac patients. No additional surgical intervention is performed beyond the standard procedure for device implantation.

Chest Wall Fat Tissue Collection

Vasvi Singh, MD

Elizabeth Fulks, MS

This single-practice prospective cohort study aims to enhance the diagnosis of cardiac amyloidosis in high-risk patients undergoing standard cardiac device implantation. By analyzing chest wall fat tissue, which is usually discarded, we aim to determine the diagnostic yield of such biopsies for amyloidosis and to develop a predictive screening model based on clinical, lab, and imaging data. The study, running from December 2023 to December 2024, expects to enroll 100 patients and may provide a new, non-invasive diagnostic avenue for this condition.

The study targets a key gap in cardiac amyloidosis diagnosis by systematically evaluating the histopathological incidence of the disease using chest wall fat pad biopsies-tissue that is typically discarded during the implantation of cardiac devices like pacemakers, ICDs, and CRT-D/Ps. Standard surgical procedures are adhered to, ensuring minimal additional risk to patients. The collected tissue samples are analyzed by the HCA pathology laboratory to detect amyloid deposits, thereby potentially identifying amyloidosis in a non-invasive manner. In addition to the primary endpoint of histopathological diagnosis, the study retrospectively aims to validate a predictive model that incorporates a wide range of data to streamline the identification of patients at high risk for cardiac amyloidosis. Strict measures are in place to protect patient confidentiality and data security. By potentially improving diagnostic efficiency, this research could contribute to earlier detection and treatment strategies, thus improving patient outcomes for those at high risk of this life-threatening condition.

The biospecimens consist of chest wall fat tissue samples collected during cardiac device implantation procedures. This adipose tissue, typically excised to create space for the device, is preserved for histopathological analysis to detect amyloid deposits. The analysis of these samples is crucial for diagnosing cardiac amyloidosis in patients at high risk. The tissue will be handled and analyzed by the HCA pathology laboratory, following standard procedures to ensure the integrity of the samples and the accuracy of the diagnostic results.

Amyloidosis Incidence in High-Risk Cardiac Device Patients

Histopathological Incidence of Amyloidosis in High-Risk Patients Undergoing Cardiac Device Implantation

At present, the specifics of a data-sharing plan for individual participant data (IPD) from this study are under consideration. The study team intends to protect patient confidentiality and data integrity and will comply with all relevant regulations and guidelines for data sharing. Once a plan has been established, details about the nature of the data to be shared, the conditions for access, and the timing for data release will be provided.

The primary outcome measure is the histopathologic diagnosis of amyloidosis in chest wall fat tissue removed during cardiac device implantation

Retrospective development and validation of a predictive model using pre-procedural clinical, lab, and imaging data to identify patients at high risk for cardiac amyloidosis

Midwest Heart & Vascular Specialists

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Lenalidomide

Dexamethasone acetate

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

As single arm study, patients will be treated as follows:

* Lenalidomide : D1\~D21 daily oral administration, starting dose 15mg, with an increase of 5mg every cycle, if tolerated, up to 25mg.
* Dexamethasone : D1\~D4 daily oral administration or intravenous injection, 40mg(or 20mg for age for age ≥ 65 years old) Patients will be treated every 4 weeks as one cycle, and up to 12 cycles of treatment will be conducted.

Lenalidomide 25mg

Youngil Koh, MD

This phase II clinical trial aimed at influencing the improvement of major organ functions, especially the objective response rate, in Amyloid light-chain amyloidosis involving myocardium.

This study was designed according to the 18F-florbetaben positron emission tomography imaging, which successfully demonstrated a significant reduction in the amount of amyloid in the heart when administered by merging thalidomide and dexamethasone in patients involving myocardium, and reported that this reaction leads to an improvement in cardiac function. Amyloid light-chain amyloidosis patients at age 19 or older with refractory or relapsed who participants should have never been exposed to lenalidomide within 5 years. Planned initial dosage of the current regimen are as follow;

* Lenalidomide : D1\~D21 daily oral administration, starting dose 15mg, with an increase of 5mg every cycle, if tolerated, up to 25mg.
* Dexamethasone : D1\~D4 daily oral administration or intravenous injection, 40mg(or 20mg for age for age ≥ 65 years old) Patients will be treated every 4 weeks as one cycle, and up to 12 cycles of treatment will be conducted. The investigator is working on a total of 30 patients, the primary endpoint of this study is objective response rate and secondary endpoints are cardiac/renal/hepatic function, 18F-florbetaben positron emission tomography imaging parameter, overall survival period, progression-free survival period, toxicity profile.

Frontline Lenalidomide for AL Amyloidosis Involving Myocardium

Frontline Lenalidomide for AL Amyloidosis Involving Myocardium: Investigation of Organ Reversing Capacity of Lenalidomide

ORR is defined as the percentage of subjects with evidence of a confirmed CR(complete response), VGPR(very good partial response) or PR(partial response)

Change of the cardiac function will be observed with the NTproBNP levels.

Change of the renal function will be observed with the 24h urine protein levels.

Change of the hepatic function will be observed with the alkaline phophatase levels.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Diagnostic Pattern and Prognosis of Multiple Myeloma Patients With Myocardial Amyloidosis Were Evaluated by NMR Based Metabolomics	NCT05718401	Multiple Myelom... Amyloidosis Car...	NMR	-	First Affiliated Hospital Xi'an Jiaotong University
Amyloidosis Incidence in High-Risk Cardiac Device Patients	NCT06186167	Amyloid Cardiac Amyloid... Amyloidosis Car... Systemic Amyloi... AL Amyloidosis Infiltrative Ca... ATTR Amyloidosi...	Chest Wall Fat ...	40 Years -	Midwest Heart & Vascular Specialists
Amyloidosis Incidence in High-Risk Cardiac Device Patients	NCT06186167	Amyloid Cardiac Amyloid... Amyloidosis Car... Systemic Amyloi... AL Amyloidosis Infiltrative Ca... ATTR Amyloidosi...	Chest Wall Fat ...	40 Years -	Midwest Heart & Vascular Specialists
The Diagnostic Pattern and Prognosis of Multiple Myeloma Patients With Myocardial Amyloidosis Were Evaluated by NMR Based Metabolomics	NCT05718401	Multiple Myelom... Amyloidosis Car...	NMR	-	First Affiliated Hospital Xi'an Jiaotong University
Amyloidosis Incidence in High-Risk Cardiac Device Patients	NCT06186167	Amyloid Cardiac Amyloid... Amyloidosis Car... Systemic Amyloi... AL Amyloidosis Infiltrative Ca... ATTR Amyloidosi...	Chest Wall Fat ...	40 Years -	Midwest Heart & Vascular Specialists
Frontline Lenalidomide for AL Amyloidosis Involving Myocardium	NCT04298372	Amyloidosis Car...	Lenalidomide 25...	19 Years - 99 Years	Seoul National University Hospital
The Diagnostic Pattern and Prognosis of Multiple Myeloma Patients With Myocardial Amyloidosis Were Evaluated by NMR Based Metabolomics	NCT05718401	Multiple Myelom... Amyloidosis Car...	NMR	-	First Affiliated Hospital Xi'an Jiaotong University
Frontline Lenalidomide for AL Amyloidosis Involving Myocardium	NCT04298372	Amyloidosis Car...	Lenalidomide 25...	19 Years - 99 Years	Seoul National University Hospital

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