Registry of Patients With Plasma Cell Disorders

NCT06286215 | Not Yet Recruiting

• 1 other identifier: 586/2564(IRB2)
• Study Type: observational
• Target: 750
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to register patients with plasma cell disorders. The main questions it aims to answer are:

• The incidence of plasma cell disorders both before and after malignancy
• Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)
• Progression free survival (PFS)
• overall survival
• factors influencing overall survival, progression-free survival, and time to progression
• Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients.
• genetic characteristics of plasma cell disorder
• cost-effectiveness of treatment in Thailand Participants will be collected the data of baseline diagnosis, treatment, treatment results of all admission and follow-up visits from hospital medical record.

Conditions

Plasma Cell Disorders

Keywords

registry; plasma cell disorder

Outcome Measures

Primary Outcomes (1)

• register the plasma cell disorder patients

  register the plasma cell disorder patients

  10 years

Secondary Outcomes (8)

• incidence of plasma cell disorders

  10 years

• Time to progression

  10 years

• Progression free survival

  10 years

• overall survival

  10 years

• influencing factors

  10 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

plasma cell disorder patients

You may qualify if:

• Both existing and newly diagnosed patients with plasma cell disorders, including monoclonal gammopathy of undetermined significance, smoldering multiple myeloma, POEMS, light chain amyloidosis, solitary plasmacytoma, and multiple myeloma, according to the diagnostic criteria of the International Myeloma Working Group 2014
• Aged 18 years and above

You may not qualify if:

• insufficient data needed for analysis

Sponsors & Collaborators

• Siriraj Hospital: lead

MeSH Terms

Conditions

Neoplasms, Plasma Cell

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Chutima Kunacheewa, MD

CONTACT

66896790959; chutima.kua@mahidol.ac.th

Weerapat Owatthanapanich, MD

CONTACT

66891081983; weerapat.owa@mahidol.ac.th

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: February 29, 2024
• Study Start: April 1, 2024
• Primary Completion (Estimated): April 1, 2034
• Study Completion (Estimated): April 1, 2035
• Last Updated: February 29, 2024

Record last verified: 2024-02