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.
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.
Italy4 sites, 4 recruiting
- 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
- Not yet 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
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.
- Conditions
- Multiple Myeloma (MM)
- Medical subject headings
- Multiple Myeloma
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted9 Jan 2025
- Study start30 Oct 2024
- Primary completion2 Apr 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Myeloma (MM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elena Zamagni, MD, PhD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Machine Learning Approach to Connect Multiple Myeloma Complexity to Early Disease Recurrence
- ClinicalTrials.gov ID
- NCT06767254
- Acronym / sponsor ID
- AIMMer
- Conditions
- Multiple Myeloma (MM)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 30 Oct 2024 (actual)
- Primary completion
- 2 Apr 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be adult patients with newly diagnosed (ND) multiple myeloma.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Signed Informed Consent form for study participation and personal data processing
- Diagnosis of active multiple myeloma
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall Response Rate
Time frame: 12 months after the start of anti-MM therapy
Overall Response Rate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Elena Zamagni, MD, PhD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
4 sites in 1 country: see every site and its status.
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.