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NCT Number: NCT05965115

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

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Monoclonal Gammopathy of Undetermined Significance Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital，Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Jing Li, M.D.

CONTACT

[email protected]

+862164041990 ext. 2025

Jing Li, M.D.

SUB_INVESTIGATOR

Peng Liu, Ph.D

CONTACT

[email protected]

+862164041990 ext. 2925

Peng Liu, Ph.D

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female over the age of 18;
  • First-degree relatives (including parents, children, and biological siblings) have multiple myeloma diagnosed by the International Myeloma Working Group (IMWG) Myeloma Diagnostic Criteria;
  • Understand the purpose and procedure of this trial and voluntarily participate in this screening study;
  • 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

Treatment and study plan

Sample of Blood

Diagnostic Test

All participants will receive M-protein screening by serum electrophoresis. Individuals with detected M-protein will undergo further diagnostic tests to determine their accurate diagnosis. Patients with monoclonal gammopathy of undetermined significance (MGUS) would be carefully assessed and followed up.

Primary outcomes

  1. The prevalence of monoclonal gammopathy of undetermined significance (MGUS) in MM first-degree relatives

    Time frame: 2 Years

    The prevalence of MGUS in MM first-degree relatives: defined as the proportion of MGUS cases among the total population ( MM first-degree relatives) receiving M-protein screening

  2. Time to progression (TTP) from MGUS to overt multiple myeloma

    Time frame: 10 Years

    The time interval between the first diagnosis of MGUS and the first recording of participants and the diagnosis of myeloma. For participants who did not record disease progression to myeloma, the last follow-up date was used as the cut-off date.

Secondary outcomes

  1. Overall survival of MGUS patients

    Time frame: 10 Years

    The time interval between the first diagnosis of MGUS and the recording of death from any cause. For participants whose death is not recorded, the cut-off date is the most recent point at which it is known that the participant is still alive.

  2. Quality of life (QoL) of MGUS patients

    Time frame: 10 Years

    QoL evaluation was performed using the Patient Self-Rating Scale (EORTC QLQ - C30) during the case screening period and at each follow-up period.

Study contacts

Contact information is provided by the study sponsor or research team.

Jing Li, MD

CONTACT

[email protected]

+8621-64041990 ext. 2025

Peng Liu, PhD, MD

CONTACT

[email protected]

+8621-64041990 ext. 2925

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Registry information

Official study title

The China Monoclonal Gammopathy Screening Project in First-degree Relatives of Patients With Multiple Myeloma (CHAPERONE) --A Multicenter Observational Study

Acronym: CHAPERONE

Important dates

Study start
2023
Primary completion
2025
Study completion
2035
First posted
Jul 28, 2023
Registry last updated
Aug 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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