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Not yet recruitingNCT06330896genetics MMUpdated Mar 26, 2024

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

An observational study in Plasma Cell Disorder, sponsored by Siriraj Hospital. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-26.

Sponsored by Siriraj Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
498
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Plasma Cell Disorder

Keywords

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

Paraproteinemias

86 studies on the registry are indexed under Paraproteinemias; 28 are open to participants now.

This study's planned enrollment of 498 is above the median of 300 across 35 observational studies indexed under Paraproteinemias.

Browse Paraproteinemias studies →

Lead sponsor

Siriraj Hospital is the lead sponsor of 95 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

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

Exclusion Criteria:

  • Patients with missing crucial data that renders them unanalyzable
  • Patients who refuse to participate in the study
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
498 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. genetic landscape of PCD

    number and percentage of genetic landscape of FISH and NGS in patients with Plasma Cell Disorders

    Time frame: 18 months in 498 patients

Secondary outcomes

  1. genetic correlation

    genetic landscape correlation between FISH and NGS in MM patients

    Time frame: 18 months in MM patients

  2. genetic landscape of relapse MM patients

    number of genetic landscape in relapse MM patients

    Time frame: 18 months in MM patients

  3. overall survival

    time of survival in MM patients

    Time frame: 18 months

  4. progression free survival

    time of disease progression in MM patients

    Time frame: 18 months

  5. factor of genetic landscape differentiation

    number of MM patients who have the different factors such as gender, age, and comorbidities.

    Time frame: 18 months in MM patients

  6. gender

    number and percentage of male and female

    Time frame: 18 months in 498 patients

  7. age

    age in years

    Time frame: 18 months in 498 patients

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided — Need a consensus from colleagues

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06330896
Lead sponsor
Siriraj Hospital
Responsible party
Chutima Kunacheewa (lecturer, Siriraj Hospital) — Principal investigator
First posted
Mar 26, 2024
Start date
Apr 1, 2024 (estimated)
Primary completion
Sep 30, 2025 (estimated)
Completion
Apr 1, 2028 (estimated)
Last update
Mar 26, 2024

Study contacts

Chutima Kunacheewa
Contact
chutima.kua@mahidol.ac.th
66896790959
Weerapat Owattanapanich
Contact
weerapat.owa@mahidol.ac.th
66891081983

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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