NCT07214324 Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution
| NCT ID | NCT07214324 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda USL Reggio Emilia - IRCCS |
| Condition | Monoclonal Gammopathy of Undetermined Significance (MGUS) |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-17 |
| Primary Completion | 2025-08-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2025-03-17 with a primary completion date of 2025-08-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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)
Contact & Investigator
Noemi Puccio
✉ noemi.puccio@ausl.re.itAntonino Neri, MD, PhD
STUDY CHAIR
Azienda USL - IRCCS di Reggio Emilia
Frequently Asked Questions
Who can join the NCT07214324 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Monoclonal Gammopathy of Undetermined Significance (MGUS). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07214324 currently recruiting?
Yes, NCT07214324 is actively recruiting participants. Contact the research team at noemi.puccio@ausl.re.it for enrollment information.
Where is the NCT07214324 trial being conducted?
This trial is being conducted at Bologna, Italy, Catania, Italy, Palermo, Italy, Reggio Emilia, Italy.
Who is sponsoring the NCT07214324 clinical trial?
NCT07214324 is sponsored by Azienda USL Reggio Emilia - IRCCS. The principal investigator is Antonino Neri, MD, PhD at Azienda USL - IRCCS di Reggio Emilia. The trial plans to enroll 60 participants.