Longitudinal Data Registry of Plasma Cell Dyscrasia

Fudan University

Status: Enrolling

Conditions: Multiple Myeloma and Other Plasma Cell Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT06760052

SHZS-PCD-001

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 19 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

2,000 participants in 1 patient group

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.