Longitudinal Data Registry of Plasma Cell Dyscrasia

Longitudinal Data Registry of a Spectrum of Plasma Cell Dyscrasia with Long-term Follow-up

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma and Other Plasma Cell Neoplasms

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

• Study Contact: Name: Peng Liu, Ph.D; Phone Number: +862164041990 ext 2315; Email: liu.peng@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Peng Liu, Ph.D; Phone Number: +862164041990 ext 2315; Email: liu.peng@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with pathological diagnosis of PCD from 2007 to 2027 according to 2016 WHO classification.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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).

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 29, 2024
• First Submitted That Met QC Criteria: December 30, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma; Paraproteinemias
• Other Study ID Numbers: SHZS-PCD-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No