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Recruiting
NCT06760052
Longitudinal Data Registry of Plasma Cell Dyscrasia
Conditions: Multiple Myeloma and Other Plasma Cell Neoplasms
Sex: All
Ages: 19 Years – 99 Years
Healthy volunteers: No
Enrollment: 2000
Sponsor: Shanghai Zhongshan Hospital
Location: Zhongshan Hospital, Fudan University Shanghai Shanghai Municipality
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 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.
Source: ClinicalTrials.gov (NCT06760052). StuddyBuddy aggregates publicly available trial information.