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

March 19, 2024 updated by: Chutima Kunacheewa, Siriraj Hospital

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

498

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Siriraj Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

April 1, 2028

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 19, 2024

First Posted (Actual)

March 26, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 19, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 346/2566(IRB3)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Need a consensus from colleagues

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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