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Recruiting NCT06760052

Longitudinal Data Registry of Plasma Cell Dyscrasia

— Observational Multiple Myeloma and Other Plasma Cell Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Multiple Myeloma and Other Plasma Cell Neoplasms. Basic parameters: 19 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Primary outcome measures

  • Overall survival [Time frame: From the time of enrollment to data cut-off (Up to approximately 20 years).]
Secondary outcome measures (1)
  • Progression-free survival [Time frame: From the time of enrollment to data cut-off (Up to approximately 20 years).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Zhongshan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT06760052 · SHZS-PCD-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗