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Multiple Myeloma (MM)NCT06767254

A Machine Learning Approach to Connect Multiple Myeloma Complexity to Early Disease Recurrence

An observational study of Multiple Myeloma (MM), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This is a non-interventional, national, multicenter prospective non-profit observational study aiming at improving the accuracy of risk prediction in multiple myeloma (MM) by applying machine-learning tools for data processing to develop model(s) predicting response to therapy and the probability of early relapse for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Myeloma (MM)
How many people
200 participants
Where
4 sitesItaly
Study dates
30 Oct 2024to 31 Aug 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Study participants will be adult patients with newly diagnosed (ND) multiple myeloma.

Who may be able to join

  • Age ≥ 18 years
  • Signed Informed Consent form for study participation and personal data processing
  • Diagnosis of active multiple myeloma

Who cannot join

  • None

Trial locations and contacts

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

Elena Zamagni, MD, PhD contact

+39 051 214 3680

e.zamagni@unibo.it

Italy4 sites, 4 recruiting
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    Bologna, 40138

    Elena Zamagni, MD, PhD, +39 051 214 3680, e.zamagni@unibo.it

    Simona Barbato, Ph.D., +39 051 214 3827, simona.barbato3@unibo.it

    Recruiting
  • ARNAS "G. Brotzu" di Cagliari

    Cagliari, 09134

    Daniele Derudas, +39 070 52965520, daniele.derudas@aob.it

    Not yet recruiting
  • Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST IRCCS

    Meldola, Forlì-Cesena, 47014

    Martina Ghetti, +39 0543 739100, martina.ghetti@irst.emr.it

    Not yet recruiting
  • Azienda Ospedaliera Universitaria Federico II

    Naples, 80131

    Barbara Izzo, +39 081 3737869, barbara.izzo@unina.it

    Not yet recruiting

Other trials in Italy

About this study

This is a non-interventional, national, multicenter prospective non-profit observational study aiming at improving the accuracy of risk prediction in multiple myeloma (MM) by applying machine-learning tools for data processing to develop model(s) predicting response to therapy and the probability of early relapse for MM patients.

Read the detailed description

Improvements in the therapy of MM have prompted the achievement of very deep clinical responses, with significantly improved outcomes and survival [2]. However, despite significant therapeutic progress, MM remains a challenge, due to the composite pathogenesis and intricate networks of different interacting factors. As a result, a relatively high proportion of NDMM patients across the different therapeutic strategies have a higher risk of disease progression and worse outcomes, independently of the anti-MM regimen received. These patients currently represent un unmet clinical need, with consequent challenges in the management of the disease and identify these patients upfront is an important goal in MM.

At present, risk stratification scores rely on a limited set of clinical and biological variables, not always sufficient to identify patients at a high risk of early disease progression or relapse (i.e., within 12 months from start of first-line therapy). Recently, AI tools have been explored to improve the accuracy of risk prediction, showing that high-risk diseases might be upfront recognized, based on tumor and immune biomarkers [3-4].

By applying Machine Learning (ML) tools for data processing, clinical, genomic, and imaging data from MM patients will be integrated and employed in models aimed at improving the accuracy of MM risk prediction. In this way, ML models will aggregate all tumor- and microenvironment-related information obtained by high-throughput technologies and omics approaches to identify and describe clusters of MM patients that best correlate with the achievement of early progression.

Overall, this study will identify new knowledge to support clinical research and decision-making in MM: precise up-front stratification of patients, based on the whole landscape of MM-related features, could improve understanding of MM individual risk. Results from this study will have an impact on the possibility to access personalized treatment, with predictable overall repercussion on the effective management of MM patients and savings for the National Health System.

Medical subject headings
Multiple Myeloma

What is being measured

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

  1. Overall Response Rate

    Overall Response Rate

    Measured: 12 months after the start of anti-MM therapy

Timeline

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

  1. First posted9 Jan 2025
  2. Study start30 Oct 2024
  3. Primary completion2 Apr 2026 (estimated)
  4. Study completion31 Aug 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
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06767254
Sponsor's protocol ID
AIMMer
Other IDs
PNRR-TR1-2023-12378246
Status last verified
Nov 2024
First submitted
2 Jan 2025
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
No
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 (MM), run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 4 sites in Italy.

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 3 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: looking for participants now, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Italy. 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?

Contact Elena Zamagni, MD, PhD (+39 051 214 3680, e.zamagni@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (time frame: 12 months after the start of anti-MM therapy). 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 9 Jan 2025.

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