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This study aims to identify clinical characteristics, response and clinical outcome of plasma cell dyscrasia (PCD) diagnosed in Zhongshan Hospital, Fudan University from May 2023. In its current version, the registry incorporates historical data (collected from 2007) and is prospectively collecting follow-up data and recording patient outcomes.
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 subtype of this disease spectrum. This study is a non-interventional real-world, study. Alll registered data are collected from real clinical practice cases. The medical data includes patient demographic, tumor characteristics, laboratory examination, history of treatments, adverse reactions, efficacy results and possible prognostic factors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enrolled patients | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | Overall survival (OS) refers to the time from receiving the first dose of regimen to death of any cause. | From the time of enrollment to data cut-off (Up to approximately 20 years). |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival | 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. | From the time of enrollment to data cut-off (Up to approximately 20 years). |
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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 Zhonshan Hospital.
Patients who had complete diagnostic, treatment and follow-up records. With fully 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 age-appropriate period.
Patients who suffered from severe mental illness. Patients who were deemed unsuitable for inclusion by the investigator.](streamdown:incomplete-link)
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Patients with pathological diagnosis of PCD from 2007 to 2027 according to 2016 WHO classification.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peng Liu, Ph.D | Contact | +862164041990 ext 2315 | liu.peng@zs-hospital.sh.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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