ClinicalTrials.gg
RecruitingNCT05283993Updated Sep 16, 2026

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

An observational study in Multiple Myeloma, Amyloidosis and Cryoglobulinemia, sponsored by Peking University First Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-09-16.

Primary conditionLeukemia, Plasma CellRegistry: Multiple MyelomaReclassifiedWhy we changed it
Registry
Multiple Myeloma — the first condition term the registry derived for this study.
ClinicalTrials.gg
Leukemia, Plasma Cell
Why
  1. The study's listed conditions name Leukemia, Plasma Cell, a narrower term within Multiple Myeloma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Peking University First Hospital · Observational

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 4 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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)
  • Monoclonal Gammopathy of Renal Significance (MGRS)
  • Monoclonal Gammopathy of Neurological Significance (MGNS)
03

In context

Leukemia, Plasma Cell Reclassified

60 studies on the registry are indexed under Leukemia, Plasma Cell; 33 are open to participants now.

Browse Leukemia, Plasma Cell studies →

Lead sponsor

Peking University First Hospital is the lead sponsor of 390 studies on the registry; 186 are open to participants now.

Compared within Leukemia, Plasma Cell, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Multiple Myeloma. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Hospitalized patients with confirmed diagnosis of PCDs will be enrolled. 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).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Significant comorbidity may be life-threatening.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • OtherNo intervention

    No intervention

06

What researchers measure

Primary outcomes

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

    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.

    Time frame: 10 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05283993
Responsible party
Yujun DONG (chief of department of hematology, Peking University First Hospital) — Principal investigator
First posted
Mar 17, 2022
Start date
Jul 1, 2021
Primary completion
Dec 31, 2030 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Sep 16, 2026

Study contacts

Bo Tang, PhD
Contact
tangbo8809@163.com
008613521776195
Yujun Dong, M.D.
Contact
dongy@hsc.pku.edu.cn
008618210264969

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion