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NCT Number: NCT07283224

Anonymization of Clinical Data From Pseudonymized Databases Collected as Part of Previus Clinical Trials on Multiple Myeloma

This is a retrospective, observational, single-center study conducted at the Hematology Unit of the IRCCS Azienda Ospedaliero-Universitaria di Bologna. The study aims to integrate genomic, clinical, and imaging data-all previously collected and pseudonymized-from earlier spontaneous studies carried out by the Hematology Unit. The main goal is to explore how genetic, clinical, and imaging features relate to disease outcomes and to develop predictive models using artificial intelligence (AI) and machine learning (ML). These models may help forecast disease progression and treatment response in the future. By combining different types of data, the research team hopes to develop new methods to predict disease progression and treatment outcomes. No new procedures, tests, or patient visits are required for this study. All the information analyzed will come from existing data collected as part of past clinical practice or previous research projects. Once anonymized, it will no longer be possible to identify individual patients. The anonymized dataset will be securely developed and stored by the bioinformatics team at the Hematology Unit of IRCCS AOUBO.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS AOU Policlinico Sant'Orsola

Bologna, Bo, 40138, Italy

Location status: Recruiting

Location contact

Carolina Terragna, MD

CONTACT

[email protected]

0512143680

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Signed Informed Consent
  • Patients with confirmed diagnosis of MM, previously enrolled in spontaneous trial conducted at the UOC Ematologia, IRCCS AOU di Bologna, from 2021, for whom pseudonymized datasets are already available at the start of this study.

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Detailed description of the genomic profiles of the BM-CD138+ compartment(s), both from BM (gDNA profile) and PB (cfDNA and CMMCs) at baseline. Description of the disease distribution with imaging techniques.

    Time frame: Baseline

Secondary outcomes

  1. Response assessment (according to the International Myeloma Working Group criteria) after anti-MM therapy and percentage of early relapse (i.e., progressive disease, PD).

    Time frame: Within 18 months from starting therapy.

Study contacts

Contact information is provided by the study sponsor or research team.

Carolina Terragna, MD

CONTACT

[email protected]

0512143831

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Dec 15, 2025
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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