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

Peking University First Hospital (Other)
Overall Status
CT.gov ID

Study Details

Study Description

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


  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 Design

Study Type:
Anticipated Enrollment :
2000 participants
Observational Model:
Time Perspective:
Official Title:
A Prospective Cohort Study of Patients With Plasma Cell Disorders (PCDs) in PKUFH
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Dec 31, 2030
Anticipated Study Completion Date :
Dec 31, 2030

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria


Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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.

Contacts and Locations


Site City State Country Postal Code
1 Peking University First Hospital Beijing China

Sponsors and Collaborators

  • Peking University First Hospital


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Yujun DONG, chief of department of hematology, Peking University First Hospital
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • PekingUFHH
First Posted:
Mar 17, 2022
Last Update Posted:
Apr 25, 2022
Last Verified:
Apr 1, 2022

Study Results

No Results Posted as of Apr 25, 2022