Longitudinal Data Registry of Plasma Cell Dyscrasia

NCT06760052 | Recruiting DMC

• 1 other identifier: SHZS-PCD-001
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Multiple Myeloma and Other Plasma Cell Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Progression-free survival

  From the time of enrollment to data cut-off (Up to approximately 20 years).

Study Arms (1)

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.

Eligibility Criteria

• Age: 19 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• Patients who refused to use reliable methods of contraception during pregnancy, lactation or age-appropriate period.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Peng Liu, Ph.D

CONTACT

+862164041990 ext 2315; liu.peng@zs-hospital.sh.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Zhongshan Hospital, Fudan University

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: January 6, 2025
• Study Start: March 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 6, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)