Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution

Recruiting now

Conditions studied: Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), Multiple Myeloma (MM)

In brief

This prospective, multicenter, observational study aims to identify molecular and immunological markers associated with disease progression in patients with monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). By integrating genomic, transcriptomic, immunophenotypic, and oral microbiome analyses, the study seeks to characterize the biological mechanisms underlying the transition to symptomatic multiple myeloma (MM). The study also includes in vitro modeling to investigate bone damage and immune dysfunction. Healthy volunteers (HV) undergoing joint replacement surgery for osteoarthritis will serve as controls. The ultimate goal is to improve early risk stratification and support future preventive strategies through a multi-omics approach. There is a pressing need for new strategies to identify high-risk individuals based on biological rather than purely clinical parameters. This study proposes an integrative, multi-omics approach to investigate the transition from MGUS/SMM to MM. By analyzing the immunome and oral microbiome alongside molecular profiling, the goal is to identify reliable biomarkers of progression. The resulting insights could be enable more accurate risk stratification and guide the design of future preventive clinical trials aimed at delaying or halting disease evolution.

Key facts

Study ID

NCT07214324

Run by

Azienda USL Reggio Emilia - IRCCS

People needed

60

Starts

2025-03-17

Expected to finish

2026-12-31

Last updated by the study team

2026-04-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• S.C Ematologia - Azienda USL IRCCS di Reggio Emilia — Reggio Emilia, Italy (enrolling)
• Istituto Ortopedico Rizzoli IRCCS — Bologna, Italy
• UO Ematologia Azienda Ospedaliero-Universitaria "Policlinico Rodolico San Marco" — Catania, Italy
• UOC di Ematologia, Dipartimento di Oncologia, AOU Policlinico "Paolo Giaccone" — Palermo, Italy

Full record on ClinicalTrials.gov

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