NCT05283993

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Jul 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jul 2021Dec 2030

Study Start

First participant enrolled

July 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 25, 2022

Status Verified

April 1, 2022

Enrollment Period

9.5 years

First QC Date

March 9, 2022

Last Update Submit

April 21, 2022

Conditions

Multiple MyelomaAmyloidosisCryoglobulinemiaCastleman's DiseaseLight Chain Deposition DiseaseHeavy Chain Deposition DiseasePolyneuropathy Organomegaly Endocrinopathy Monoclonal Gammopathy and Skin ChangesSmoldering Multiple MyelomaPlasma Cell LeukemiaMonoclonal Gammopathy of Undetermined Significance (MGUS)Monoclonal Gammopathy of Renal Significance (MGRS)Monoclonal Gammopathy of Neurological Significance (MGNS)

Outcome Measures

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.

    10 years

Interventions

No interventionOTHER

No intervention

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • Patients included are those with confirmed diagnosis of PCDs and hospitalized into Peking University First Hospital (PKUFH)
  • 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).
  • Patients are included into this cohort after signing the ICFs.

You may not qualify if:

  • Significant comorbidity may be life-threatening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood, bone marrow aspirate and urine samples will be banked for future research involving adults with PCDs.

MeSH Terms

Conditions

Multiple MyelomaAmyloidosisCryoglobulinemiaCastleman DiseasePOEMS SyndromeSmoldering Multiple MyelomaLeukemia, Plasma CellMonoclonal Gammopathy of Undetermined Significance

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPrecancerous ConditionsHypergammaglobulinemiaLeukemia

Central Study Contacts

Bo Tang, PhD

CONTACT

008613521776195tangbo8809@163.com

Yujun Dong, M.D.

CONTACT

008618210264969dongy@hsc.pku.edu.cn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief of department of hematology

Study Record Dates

First Submitted

March 9, 2022

First Posted

March 17, 2022

Study Start

July 1, 2021

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 25, 2022

Record last verified: 2022-04

Locations

CN(1)