Status:
ACTIVE_NOT_RECRUITING
Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution
Lead Sponsor:
Azienda USL Reggio Emilia - IRCCS
Collaborating Sponsors:
European Union Next Generation
Ministero della Salute, Italy
Conditions:
Monoclonal Gammopathy of Undetermined Significance (MGUS)
Smoldering Multiple Myeloma (SMM)
Eligibility:
All Genders
18+ years
Brief Summary
This prospective, multicenter, observational study aims to identify molecular and immunological markers associated with disease progression in patients with monoclonal gammopathy of undetermined signi...
Detailed Description
Multiple myeloma (MM) is a hematologic malignancy characterized by the clonal proliferation of antibody-secreting plasma cells in the bone marrow. It accounts for approximately 10% of all blood cancer...
Eligibility Criteria
Inclusion
- Age \>18 years
- Male or female patients
- Histologically confirmed diagnosis of MGUS, SMM, or MM according to ESMO 2021 guidelines
- Willing and able to provide written informed consent
- HEALTHY VOLUNTEERS (HV)
- Age \>60 years
- Diagnosis of osteoarthritis (OA)
- Scheduled for hospitalization for surgical treatment of OA (endoprosthesis or arthroplasty)
- Willing and able to provide written informed consent
Exclusion
- Patients:
- Active current infection
- Autoimmune disease
- Women of childbearing potential unable to exclude pregnancy
- Use of high-dose corticosteroids within the past 7 days, potentially affecting immunome composition
- Healthy Volunteers:
- Prior joint surgery or severe joint deformity
- Recent trauma, osteonecrosis, or OA caused by prior/current joint infection
- Metabolic disorders
- Previous or current cancer diagnosis
- Autoimmune diseases (e.g., rheumatoid arthritis)
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT07214324
Start Date
January 1 2023
End Date
December 31 2025
Last Update
November 19 2025
Active Locations (4)
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1
Istituto Ortopedico Rizzoli IRCCS
Bologna, Italy
2
UO Ematologia Azienda Ospedaliero-Universitaria "Policlinico Rodolico San Marco"
Catania, Italy
3
UOC di Ematologia, Dipartimento di Oncologia, AOU Policlinico "Paolo Giaccone"
Palermo, Italy
4
S.C Ematologia - Azienda USL IRCCS di Reggio Emilia
Reggio Emilia, Italy