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NCT Number: NCT06760052

Longitudinal Data Registry of Plasma Cell Dyscrasia

The goal of this multicenter observational study is to better understand the clinical and molecular characteristics, disease progression, treatment response, and clinical outcomes of patients with plasma cell dyscrasias, including monoclonal gammopathy of undetermined significance (MGUS), multiple myeloma, and light-chain amyloidosis. The study is led by Zhongshan Hospital, Fudan University, in collaboration with 18 other research centers in China. The main questions it aims to answer are:

Which clinical, laboratory, pathological, immunologic, cytogenetic, and genomic characteristics are associated with disease progression, treatment response, and patient outcomes? How do plasma cell dyscrasias and their underlying clones evolve over time? Can clinical and molecular information be used to develop models that predict disease progression and patient outcomes?

Researchers will collect and analyze historical and prospective clinical data from participating centers and follow patients over time. Participants' clinical course, laboratory and other test results, treatments, disease progression, and outcomes will be recorded and analyzed. This is an observational study and does not assign participants to any specific treatment.

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Key information

Conditions

Multiple Myeloma and Other Plasma Cell Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell

Age range

19 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location status: Recruiting

Location contact

Peng Liu, Ph.D

CONTACT

[email protected]

+862164041990 ext 2315

About this study

PCD is a spectrum of diseases that is being gradually understood in Asia. This study aims to observe and describe the clinical and genetic characteristics of Chinese PCD patients, and to explore the relationship between the characteristics and pathogenesis. It also aims to discover the potential distinct clonal evolution patterns among different subtypes of this disease spectrum. This study is a non-interventional, real-world, multicenter study. All registered data are collected from real-world clinical practice. The medical data include patient demographics, tumor characteristics, laboratory examinations, treatment history, adverse reactions, efficacy results, and potential prognostic factors.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with pathological diagnosis of PCD [e.g., symptomatic/asymptomatic multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), POEMS syndrome, light chain (AL) amyloidosis] from 2007 to 2027 in Zhongshan Hospital or other collaborating centers.
  • Patients who had complete diagnostic, treatment, and follow-up records.
  • Patients with full comprehension and signature of the informed consent form (ICF) for participation.

Exclusion criteria

  • Patients who refused to use reliable methods of contraception during pregnancy, lactation, or the age-appropriate period.
  • Patients who suffered from severe mental illness.
  • Patients who were deemed unsuitable for inclusion by the investigator.

Treatment and study plan

Primary outcomes

  1. Overall survival

    Time frame: From the time of enrollment to data cut-off (Up to approximately 20 years).

    Overall survival (OS) refers to the time from receiving the first dose of regimen to death of any cause.

Secondary outcomes

  1. Progression-free survival

    Time frame: From the time of enrollment to data cut-off (Up to approximately 20 years).

    Progression-free survival (PFS) is defined as the time from the date of first administration to the date of first disease progression or death of any cause, whichever occurs first.

Study contacts

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

Peng Liu, Ph.D

CONTACT

[email protected]

+862164041990 ext 2315

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • First Affiliated Hospital of Wenzhou Medical University
  • Guangdong Provincial People's Hospital
  • Huadong Hospital
  • Huzhou Central Hospital, Affiliated Central Hospital HuZhou University
  • Peking University First Hospital
  • Peking University Shenzhen Hospital
  • Shanghai Geriatric Medical Center (Zhongshan Hospital Fudan University Minhang Campus)
  • Shenzhen People's Hospital (the Second Clinical Medical College, Jinan University
  • Sir Run Run Shaw Hospital
  • Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
  • The First Affiliated Hospital with Nanjing Medical University
  • The First Affiliated Hospital, Fujian Medical University
  • The Third Affiliated Hospital of Nanjing Medical University
  • Tongji Hospital
  • Zhangzhou Affiliated Hospital of Fujian Medical University
  • Zhejiang Provincial Tongde Hospital
  • Zhongshan Hospital Xiamen University

Registry information

Official study title

Longitudinal Data Registry of A Spectrum of Plasma Cell Dyscrasia With Long-term Follow-up

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Jan 6, 2025
Registry last updated
Aug 3, 2026

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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