Early Screening for Multiple Myeloma Based on Liquid Biopsy cfDNA Fragmentomics

Study Population Description Target Population: Chinese adults aged 40 years, including patients with plasma cell dyscrasias and healthy controls.

Patient Group: Individuals with a laboratory- and clinically-confirmed diagnosis of MM, SMM, or MGUS following standard diagnostic guidelines.

Healthy Controls: Age-matched healthy individuals with no active malignancies or major systemic diseases.

General Eligibility Summary: All participants must voluntarily sign a written informed consent form. Individuals with recent blood transfusions (within 7 days), prior histories of other cancers or systemic oncology therapies within 5 years, or histories of organ/allogeneic transplants will be excluded, alongside any candidates deemed ineligible by the investigator.

Inclusion Criteria:

• Age over 40 years.
• Diagnosed with MM, SMM, or MGUS through standard diagnostic procedures.
• Voluntarily participating and signed written informed consent.

Exclusion Criteria:

• Pregnant or lactating women.
• Prior cancer diagnosis within the past 5 years, or history of any form of systemic cancer therapy (including chemotherapy, targeted therapy, immunotherapy, etc.).
• History of organ transplantation, or allogeneic bone marrow or stem cell transplantation.
• History of blood transfusion within 7 days prior to blood collection.
• Poor compliance or potential interference with signing informed consent as judged by the investigator, or any other conditions rendering the subject unsuitable for the study.