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NCT Number: NCT06760052

Longitudinal Data Registry of Plasma Cell Dyscrasia

This study aims to identify clinical characteristics, response and clinical outcome of plasma cell dyscrasia (PCD) diagnosed in Zhongshan Hospital, Fudan University from May 2023. In its current version, the registry incorporates historical data (collected from 2007) and is prospectively collecting follow-up data and recording patient outcomes.

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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 subtype of this disease spectrum. This study is a non-interventional real-world, study. Alll registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible 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 Zhonshan Hospital.

Patients who had complete diagnostic, treatment and follow-up records. With fully 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 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

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
Jan 6, 2025

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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