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Multiple MyelomaAINCT07410403

AI-Based Fine Morphological Subtyping of Myeloma Single Cells for Predicting FISH Abnormalities

An observational study of Multiple Myeloma, run by Fuling Zhou at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study developed an artificial intelligence (AI)-based methodology for the quantitative analysis of single-cell morphological data in multiple myeloma (MM). The approach achieves high-precision AI-driven identification and segmentation of myeloma cells, nuclei, cytoplasm, and nucleoli, overcoming the inherent… Read more about this study

Who is it for?
Any age
Conditions the study is for
Multiple Myeloma
How many people
10 participants
Where
1 siteChina
Study dates
1 Aug 2018to 31 Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: according to the criteria outlined in the Chinese guidelines for MM diagnosis and management (2024 edition)

Who may be able to join

  • according to the criteria outlined in the Chinese guidelines for MM diagnosis and management (2024 edition)

Who cannot join

  • non-MM

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site
  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei, 410071

Other trials in China

About this study

This study developed an artificial intelligence (AI)-based methodology for the quantitative analysis of single-cell morphological data in multiple myeloma (MM). The approach achieves high-precision AI-driven identification and segmentation of myeloma cells, nuclei, cytoplasm, and nucleoli, overcoming the inherent limitations of subjective traditional morphological analysis.

Furthermore, integrating this morphological quantification with cytogenetic abnormality analysis of myeloma cells provides an efficient predictive tool for identifying high-risk cytogenetic abnormalities.

Leveraging AI-guided selection of genetic testing targets, the research applied a rapid genetic abnormality detection technique utilizing first-drop bone marrow aspirate smears. This methodology achieves orders of magnitude improvements in testing cost, sample preprocessing time and detection sensitivity.

Read the detailed description

Multiple myeloma (MM) is a malignant plasma cell disorder exhibiting a rising global incidence associated with population aging. The significant intraclonal heterogeneity and complexity of clonal evolution inherent in MM genetics contribute to profound inter-individual heterogeneity. This complicates precise prognostic stratification and disease management, rendering MM largely incurable even in the era of novel therapies. In early-stage MM, primary cytogenetic abnormalities predominantly include odd-numbered chromosome trisomies and immunoglobulin heavy chain gene (IGH) rearrangements, such as t(11;14) and t(4;14). Disease progression and terminal stages are frequently characterized by the acquisition of increasingly complex copy number alterations (CNAs) (e.g., 1q gain/amplification [1q+] and 17p deletion [17p-]) and MYC rearrangements. These secondary events further drive cellular proliferation and tumor growth, collectively contributing to MM's high aggressiveness and therapeutic resistance.

Fluorescence in situ hybridization (FISH), particularly when combined with CD138 immunomagnetic bead sorting for plasma cell enrichment, plays a pivotal role in enhancing the detection rate of cytogenetic abnormalities in MM. However, a comprehensive MM genetic assessment necessitates the selection of multiple FISH probes targeting diverse genetic events, including several associated with high-risk progression. This requirement introduces significant complexity in probe selection. The Mayo Clinic utilizes an initial FISH screening panel for newly diagnosed MM targeting loci on chromosomes 1, 3, 7, 8, 9, 11, 13, 14, 15, and 17. Based on the results from the IGH break-apart probe on chromosome 14 (identifying an IGH break in approximately 50% of NDMM cases), positive cases undergo additional FISH testing for specific translocations: t(4;14), t(6;14), t(14;16), and t(14;20). Nevertheless, implementing such a comprehensive FISH approach is often hindered by the large number of required targets, limited plasma cell yields after bead enrichment/purification, and potential FISH assay failure.

While FISH is crucial for detecting MM cytogenetic abnormalities, current National Comprehensive Cancer Network (NCCN) guidelines highlight up to seven specific high-risk cytogenetic abnormalities associated with progression/relapse in NDMM: 1q21 gain (1q21+), 1p32 deletion (1p32-), del(17p)/monosomy 17 (-17)/TP53 mutation, t(4;14), t(14;16), t(14;20), and MYC rearrangement. The practical clinical application and accuracy of FISH are frequently limited by the extensive number of targets required for a complete assessment and the variability/complexity of standard FISH methodologies. An initial FISH screen must include an IGH break-apart probe. Subsequent testing with specific fusion probes for t(11;14), t(4;14), t(6;14), t(14;16), and t(14;20) is performed only if the IGH break-apart probe is positive.

Previous studies have reported on prognostic significance based on expert morphological classification of myeloma cells into plasmablastic, immature, and mature plasma cell types. However, utilizing myeloma cell morphology to predict specific FISH-detectable cytogenetic abnormalities remains unexplored. Artificial intelligence (AI) has demonstrated growing applications in medical image recognition and classification, including high-precision identification of leukemia, lymphoma, and MM cells. Recent research reported AI's ability to identify four specific acute leukemia molecular subtypes (PML::RARA fusion-positive; NPM1-mutated; CBFB::MYH11 fusion-positive without NPM1 mutation; RUNX1::RUNX1T1 fusion-positive) based on leukemia cell morphology in peripheral blood smears. Yet, analogous studies predicting cytogenetic abnormalities from MM cell morphology are currently lacking.

Keywords
artificial intelligence, myeloma, genetic
Medical subject headings
Multiple Myeloma, Neoplasms, Plasma Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07410403
Study groupRoleWhat they receive
myelomahigh-precision AI-driven identification and segmentation of myeloma cells, nuclei, cytoplasm, and nucleoli, overcoming the inherent limitations of subjective traditional morphological analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cytogenetic result of multiple myeloma

    To predict cytogenetic result of multiple myeloma, using high-precision AI-driven identification and segmentation of myeloma cells, nuclei, cytoplasm, and nucleoli.

    Measured: 2 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2026
  2. Study start1 Aug 2018
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07410403
Sponsor's protocol ID
441435122
Acronym
AI
Status last verified
Feb 2026
First submitted
16 Jun 2025
Last updated
13 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Myeloma, run by Fuling Zhou at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cytogenetic result of multiple myeloma (time frame: 2 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.

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