Longitudinal Data Registry of Plasma Cell Dyscrasia

NCT ID: NCT06760052

Last Updated: 2025-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Multiple Myeloma and Other Plasma Cell Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Peng Liu

Zhongshan Hospital, Fudan University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng Liu, Ph.D

Role: CONTACT

+862164041990 ext 2315

Facility Contacts

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Peng Liu, Ph.D

Role: primary

+862164041990 ext 2315

Other Identifiers

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SHZS-PCD-001

Identifier Type: -

Identifier Source: org_study_id

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