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

The goal of this multicenter observational study is to better understand the clinical and molecular characteristics, disease progression, treatment response, and clinical outcomes of patients with plasma cell dyscrasias, including monoclonal gammopathy of undetermined significance (MGUS), multiple myeloma, and light-chain amyloidosis. The study is led by Zhongshan Hospital, Fudan University, in collaboration with 18 other research centers in China. The main questions it aims to answer are: Which clinical, laboratory, pathological, immunologic, cytogenetic, and genomic characteristics are associated with disease progression, treatment response, and patient outcomes? How do plasma cell dyscrasias and their underlying clones evolve over time? Can clinical and molecular information be used to develop models that predict disease progression and patient outcomes? Researchers will collect and analyze historical and prospective clinical data from participating centers and follow patients over time. Participants' clinical course, laboratory and other test results, treatments, disease progression, and outcomes will be recorded and analyzed. This is an observational study and does not assign participants to any specific treatment.

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 Zhongshan Hospital or other collaborating centers.
• Patients who had complete diagnostic, treatment, and follow-up records.
• Patients with full 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 the age-appropriate period.
• Patients who suffered from severe mental illness.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Tongji Hospital: collaborator
• Peking University First Hospital: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Zhongshan Hospital Xiamen University: collaborator
• First Affiliated Hospital of Wenzhou Medical University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• Zhangzhou Affiliated Hospital of Fujian Medical University: collaborator
• Huadong Hospital: collaborator
• Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University: collaborator
• The Third Affiliated Hospital of Nanjing Medical University: collaborator
• Peking University Shenzhen Hospital: collaborator
• Zhejiang Provincial Tongde Hospital: collaborator
• Shenzhen People's Hospital (the Second Clinical Medical College, Jinan University: collaborator
• Shanghai Geriatric Medical Center (Zhongshan Hospital Fudan University Minhang Campus): collaborator
• The First Affiliated Hospital, Fujian Medical University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• Huzhou Central Hospital, Affiliated Central Hospital HuZhou University: collaborator

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: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)