A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH

Recruiting

• Conditions: Multiple Myeloma; Amyloidosis; Cryoglobulinemia; Castleman's Disease; Light Chain Deposition Disease; Heavy Chain Deposition Disease; Polyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin Changes; Smoldering Multiple Myeloma; Plasma Cell Leukemia; Monoclonal Gammopathy of Undetermined Significance (MGUS)

• Registration Number: NCT05283993
• Lead Sponsor: Peking University First Hospital

Brief Summary

The primary aim is to establish a prospective cohort of patients with plasma cell disorders (PCDs). All of the hospitalized PCD patients who are willing to sign the informed consent form (ICF) will be included in this study. Clinical characteristics, treatment options and responses will be collected. Peripheral blood, bone marrow aspirate and urine samples before and after the treatment will banked for future research. Our team will focus on the clinical and pathological features of PCDs, the correlation between the minimal residual disease (MRD) status and prognosis, and the role of Tumor Microenvironment (TME) in the pathogenesis and progress of PCDs.

Detailed Description

Primary

1. To establish a prospective cohort of patients with PCDs in PKUFH.

2. To dynamically analyze the relation between MRD status and prognosis, and the possible role of TME in PCD patients.

Secondary To collect peripheral blood, bone marrow aspirate and urine samples from PCD patients for future study, such as the tumor clone selection and evolution.

OUTLINE: PCD patients enrolled in this study will be assessed at baseline, clinical and laboratory data and biological samples be collected. Follow-up will be done at the 1, 3, 6, 12 months and then yearly after treatment.

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-03-16
• Study First Posted: 2022-03-17
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-25
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

1. Patients included are those with confirmed diagnosis of PCDs and hospitalized into Peking University First Hospital (PKUFH)
2. Patients of plasma cell disorders (PCDs) are recruited. PCDs include monoclonal gammopathy of uncertain significance; smoldering myeloma; multiple myeloma; plasma cell leukemia; amyloidosis; light chain deposition disease; heavy chain deposition disease; Castleman's disease (CD); Polyneuropathy, Organomegaly, Endocrinopathy, Monoclonal gammopathy and Skin changes syndrome; cryoglobulinemia; Monoclonal Gammopathy of Renal Significance (MGRS); Monoclonal gammopathy of neurological significance (MGNS).
3. Patients are included into this cohort after signing the ICFs.

Exclusion Criteria

Significant comorbidity may be life-threatening.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A Cohort Study of Plasma Cell Disorders (PCDs) in PKUFH	10 years	To measure the treatment response in the cohort study of PCDs in PKUFH.The treatment response is done according to the criteria of the International Myeloma Working Group (IWMG) of 2016.

Trial Locations

Locations (1)

Peking University First Hospital; 🇨🇳 Beijing, China