Clinical trial · Observational
Longitudinal Data Registry of Plasma Cell Dyscrasia
Longitudinal Data Registry of A Spectrum of Plasma Cell Dyscrasia With Long-term Follow-up
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma and Other Plasma Cell Neoplasms | Plasma Cell Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Enrolled patients
- description
- The final personalized management strategy is determined based on both current conventional treatment options and physicians' and patients' preferences. The following agents might be applied: proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), alkylating agents, anti-CD38 monoclonal antibodies, bispecific antibodies, and cell therapy, with or without steroids.
Primary outcomes (1)
- measure
- Overall survival
- timeFrame
- From the time of enrollment to data cut-off (Up to approximately 20 years).
- description
- Overall survival (OS) refers to the time from receiving the first dose of regimen to death of any cause.
Secondary outcomes (1)
- measure
- Progression-free survival
- timeFrame
- From the time of enrollment to data cut-off (Up to approximately 20 years).
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available