NCT07214324Recruiting
Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution
Source: ClinicalTrials.gov · Last updated 23 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 2 Oct 2025
- Start date
- 17 Mar 2025
- Primary completion date
- 12 Aug 2025
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Diseases
- Multiple myeloma
- NCT number
- NCT07214324
What you commit to
- Study type: Observational
- Planned participants: 60
- From 17 Mar 2025 to the primary completion date, 12 Aug 2025
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior joint surgery or severe joint deformity
- Recent trauma, osteonecrosis, or OA caused by prior/current joint infection
- Previous or current cancer diagnosis
Other illness
- 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:
- Metabolic disorders
- Autoimmune diseases (e.g., rheumatoid arthritis)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Istituto Ortopedico Rizzoli IRCCS Coordinator of this site? Confirm its status | Bologna | Italy | Active, not recruiting |
| UO Ematologia Azienda Ospedaliero-Universitaria "Policlinico Rodolico San Marco" Coordinator of this site? Confirm its status | Catania | Italy | Active, not recruiting |
| UOC di Ematologia, Dipartimento di Oncologia, AOU Policlinico "Paolo Giaccone" Coordinator of this site? Confirm its status | Palermo | Italy | Active, not recruiting |
| S.C Ematologia - Azienda USL IRCCS di Reggio Emilia Coordinator of this site? Confirm its status | Reggio Emilia | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.