Multiple Myeloma and Other Plasma Cell Neoplasms
Conditions
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.
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 subtypes of this disease spectrum. This study is a non-interventional, real-world, multicenter study. All registered data are collected from real-world clinical practice. The medical data include patient demographics, tumor characteristics, laboratory examinations, treatment history, adverse reactions, efficacy results, and potential prognostic factors.
Interventions
None listed
Sponsors
Shanghai Zhongshan Hospital
Tongji Hospital
Peking University First Hospital
The First Affiliated Hospital with Nanjing Medical University
Zhongshan Hospital Xiamen University
First Affiliated Hospital of Wenzhou Medical University
Sir Run Run Shaw Hospital
Zhangzhou Affiliated Hospital of Fujian Medical University
Huzhou Central Hospital, Affiliated Central Hospital HuZhou University
Huadong Hospital
Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University
The Third Affiliated Hospital of Nanjing Medical University
Peking University Shenzhen Hospital
Zhejiang Provincial Tongde Hospital
Shenzhen People's Hospital (the Second Clinical Medical College, Jinan University
Shanghai Geriatric Medical Center (Zhongshan Hospital Fudan University Minhang Campus)
The First Affiliated Hospital, Fujian Medical University
Guangdong Provincial People's Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
19 Years to 99 Years
Healthy volunteers
No
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 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.
Exclusion criteria
* Patients who refused to use reliable methods of contraception during pregnancy, lactation, or the age-appropriate period. * Patients who suffered from severe mental illness. * Patients who were deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From the time of enrollment to data cut-off (Up to approximately 20 years). | Overall survival (OS) refers to the time from receiving the first dose of regimen to death of any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival | From the time of enrollment to data cut-off (Up to approximately 20 years). | 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. |
Countries
China
Contacts
CONTACTPeng Liu, Ph.D
Outcome results
None listed