Primary Amyloidosis Clinical Trials

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Longitudinal Data Registry of A Spectrum of Plasma Cell Dyscrasia With Long-term Follow-up

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Peng Liu, Ph.D
liu.peng@zs-hospital.sh.cn
+862164041990 ext 2315
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 2000
Treatments
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.
Sponsors
Collaborators: The Third Affiliated Hospital of Nanjing Medical University, First Affiliated Hospital of Wenzhou Medical University, Peking University First Hospital, The First Affiliated Hospital with Nanjing Medical University, Sir Run Run Shaw Hospital, Shenzhen People's Hospital (the Second Clinical Medical College, Jinan University, Zhongshan Hospital Xiamen University, The First Affiliated Hospital, Fujian Medical University, Huzhou Central Hospital, Affiliated Central Hospital HuZhou University, Huadong Hospital, Guangdong Provincial People's Hospital, Tongji Hospital, Peking University Shenzhen Hospital, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhejiang Provincial Tongde Hospital, Taizhou Hospital of Zhejiang Province affiliated to Wenzhou Medical University, Shanghai Geriatric Medical Center (Zhongshan Hospital Fudan University Minhang Campus)
Leads: Shanghai Zhongshan Hospital

This content was sourced from clinicaltrials.gov