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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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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Response assessment (according to the International Myeloma Working Group criteria) after anti-MM therapy and percentage of early relapse (i.e., progressive disease, PD). | Within 18 months from starting therapy. |
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Inclusion Criteria:
Exclusion Criteria:
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Existent pseudonymized data have been collected from adult patients (i.e., aged ≥18 years) with a confirmed diagnosis of active MM, according to the International Myeloma Working Group (IMWG) criteria. All patients whose data will be anonymized have previously been enrolled in spontaneous trials conducted from 2021 at the UOC Ematologia, IRCCS AOUBO. No further data collection is required other than data already collected both at diagnosis and after treatment in the context of previous studies, upon anonymization.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Terragna, MD | Contact | 0512143831 | carolina.terragna@unibo.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS AOU Policlinico Sant'Orsola | Recruiting | Bologna | Bo | 40138 | Italy |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |