Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing

Plasma Cell Disorder Clinical Trial

— genetics MM  

Official title:

Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06330896
• Other study ID #: 346/2566(IRB3)
• Status: Not yet recruiting
• Start date: April 1, 2024
• Est. completion date: April 1, 2028

Study information

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

Clinical Trial Summary

The goal of this observational study is to study the genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand. The main questions it aims to answer are:

• genetic landscape in patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis in Thailand who were performed FISH and/or NGS testing

• genetic correlation and genetic dependency between FISH and NGS, stratified by high- and standard-risk groups based on FISH testing in Thai MM patients.

• disease characteristics and response rates in MM patients with cytogenetic abnormalities detected by FISH and/or genetic mutations detected by NGS.

• correlation between cytogenetic abnormalities identified by FISH and genetic mutations detected by NGS with progression-free survival in MM patients.

The FISH and/or NGS testing results, disease characteristics, treatment, and treatment outcomes of patients with plasma cell disorders who underwent FISH and/or NGS testing before IRB approval will be collected through retrospective chart review. Subsequently, data will be gathered prospectively. Participants will provide approximately 12 mL of bone marrow fluid for FISH and NGS testing.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 498
• Est. completion date: April 1, 2028
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with Plasma Cell Disorders including MGUS, SMM, MM, and amyloidosis

• Aged 18 years and older

• Performed FISH and/or NGS testing

• Has treatment follow up at least one year

Exclusion Criteria:

• Patients with missing crucial data that renders them unanalyzable

• Patients who refuse to participate in the study

Related Conditions & MeSH terms

• Congenital Abnormalities
• Paraproteinemias
• Plasma Cell Disorder

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Siriraj Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	genetic landscape of PCD	number and percentage of genetic landscape of FISH and NGS in patients with Plasma Cell Disorders	18 months in 498 patients
Secondary	genetic correlation	genetic landscape correlation between FISH and NGS in MM patients	18 months in MM patients
Secondary	genetic landscape of relapse MM patients	number of genetic landscape in relapse MM patients	18 months in MM patients
Secondary	overall survival	time of survival in MM patients	18 months
Secondary	progression free survival	time of disease progression in MM patients	18 months
Secondary	factor of genetic landscape differentiation	number of MM patients who have the different factors such as gender, age, and comorbidities.	18 months in MM patients
Secondary	gender	number and percentage of male and female	18 months in 498 patients
Secondary	age	age in years	18 months in 498 patients