Registry of Patients With Plasma Cell Disorders

Plasma Cell Disorders Clinical Trial

— Registry PCD  

Official title:

Registry of Patients With Plasma Cell Disorders

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06286215
• Other study ID #: 586/2564(IRB2)
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: April 1, 2035

Study information

• Verified date: February 2024
• Source: Siriraj Hospital
• Contact: Chutima Kunacheewa, MD
• Phone: 66896790959
• Email: chutima.kua[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 750
• Est. completion date: April 1, 2035
• Est. primary completion date: April 1, 2034
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• insufficient data needed for analysis

Related Conditions & MeSH terms

• Paraproteinemias
• Plasma Cell Disorders

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Siriraj Hospital	Faculty of Medicine Siriraj Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	register the plasma cell disorder patients	register the plasma cell disorder patients	10 years
Secondary	incidence of plasma cell disorders	incidence of plasma cell disorders both before and after malignancy	10 years
Secondary	Time to progression	- Time to progression of monoclonal gammopathy of undetermined significant (MGUS) or smoldering multiple myeloma (SMM) to light chain amyloidosis or multiple myeloma (MM)	10 years
Secondary	Progression free survival	Progression free survival	10 years
Secondary	overall survival	overall survival	10 years
Secondary	influencing factors	factors influencing overall survival, progression-free survival, and time to progression	10 years
Secondary	Symptoms and signs	Symptoms and signs of the disease during the diagnosis and relapse phases, including the causes of mortality in plasma cell disorder patients	10 years
Secondary	genetic characteristics	genetic characteristics of plasma cell disorder	10 years
Secondary	cost-effectiveness	cost-effectiveness of treatment in Thailand	10 years