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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06330896

Acronym

genetics MM

Enrollment

498

Registered

2024-03-26

Start date

2024-04-01

Completion date

2028-04-01

Last updated

2024-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Plasma Cell Disorder

Keywords

Plasma Cell Disorder, genetic abnormalities, Fluorescence In Situ Hybridization, FISH, Next Generation Sequencing, NGS

Brief 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
genetic landscape of PCD	18 months in 498 patients	number and percentage of genetic landscape of FISH and NGS in patients with Plasma Cell Disorders

Secondary

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

Contacts

Primary ContactChutima Kunacheewa

chutima.kua@mahidol.ac.th66896790959

Backup ContactWeerapat Owattanapanich

weerapat.owa@mahidol.ac.th66891081983

Outcome results