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The China M-protein Screening Project in First-degree Relatives of Myeloma Patient - The CHAPERONE Study

The China M-protein Screening Project in First-degree Relatives of Myeloma Patient - The CHAPERONE Study

Recruiting
18 years and older
All
Phase N/A

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Overview

The goal of the China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) study is to assess the clinical significance of screening for monoclonal gammopathy (M-protein) in first-degree relatives of patients with multiple myeloma in China population, and establish a prospective cohort of individuals with monoclonal gammopathy of undetermined significance (MGUS), a precursor conditions to multiple myeloma. We will study these patients as a means to identify risk factors for progression to symptomatic multiple myeloma.

Description

The CHAPERONE study aims to assess the clinical significance of screening for monoclonal gammopathy in first-degree relatives of patients with multiple myeloma in China.

The main objectives it aims to answer are:

  • Main research objectives: To study the prevalence of MGUS, the time of disease progression, and its influencing factors in first-degree relatives of multiple myeloma patients in China.
  • Secondary study objective: To explore the clinical/genomic/epigenetic features, survival, and quality of life of MGUS patients in first-degree relatives of multiple myeloma patients in China.

All participants will receive M-protein screening by serum electrophoresis. Individuals with detected M-protein will undergo further diagnostic tests, and patients with MGUS will be carefully assessed and followed up.

Eligibility

Inclusion Criteria:

  1. Male or female over the age of 18;
  2. First-degree relatives (including parents, children, and biological siblings) have multiple myeloma diagnosed by the International Myeloma Working Group (IMWG) Myeloma Diagnostic Criteria;
  3. Understand the purpose and procedure of this trial and voluntarily participate in this screening study;
  4. Participants should be willing and able to follow the study follow-up plan and other protocol requirements.

Exclusion Criteria:

        Patients with a known diagnosis of plasma cell diseases, such as MGUS, smoldering myeloma
        (SMM), or multiple myeloma

Study details
    Multiple Myeloma
    Monoclonal Gammopathy of Undetermined Significance

NCT05965115

Shanghai Zhongshan Hospital

26 January 2024

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