RecruitingNot Applicable

Longitudinal Data Registry of Plasma Cell Dyscrasia

China2,000 participantsStarted 2023-03-01

Plain-language 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.

Who can participate

Age range

19 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall survival

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

Trial details

NCT IDNCT06760052

SponsorShanghai Zhongshan Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-12-31

Contact for this trial

Peng Liu, Ph.D

+862164041990 ext 2315 liu.peng@zs-hospital.sh.cn

View on ClinicalTrials.gov More Multiple Myeloma and Other Plasma Cell Neoplasms trials