Disease Characteristics and Treatment Response in Plasma Cell Disorders Patients Based on Genetic Abnormalities From Fluorescence In Situ Hybridization and Next Generation Sequencing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Plasma Cell Disorder. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- genetic landscape of PCD [Time frame: 18 months in 498 patients]
Secondary outcome measures (7)
- genetic correlation [Time frame: 18 months in MM patients]
- genetic landscape of relapse MM patients [Time frame: 18 months in MM patients]
- overall survival [Time frame: 18 months]
- progression free survival [Time frame: 18 months]
- factor of genetic landscape differentiation [Time frame: 18 months in MM patients]
- gender [Time frame: 18 months in 498 patients]
- age [Time frame: 18 months in 498 patients]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06330896 · 346/2566(IRB3)