Longitudinal Data Registry of Plasma Cell Dyscrasia

NCT06760052 · tracked via the Priya Life Science China tracker

Sponsor

Shanghai Zhongshan Hospital

Phase

Observational

Started

2023-03-01

Last updated

2026-08-03

Condition(s) studied

Multiple Myeloma and Other Plasma Cell Neoplasms

Study summary

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.

Eligibility

Sex

ALL

Min age

19 Years

Max age

99 Years

Healthy volunteers

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.

Primary outcome measure(s)

Overall survival — 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.

Trial sites (1)

Facility	City	Region	Status
Zhongshan Hospital, Fudan University	Shanghai	Shanghai Municipality	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06760052 on ClinicalTrials.gov ↗ ← All trials in China