Multi-omics profiling to predict progression from MGUS and smoldering myeloma to symptomatic multiple myeloma
Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution
This project will try to see if combined genomic, immune, and oral microbiome tests can predict which people with MGUS or smoldering myeloma will progress to symptomatic multiple myeloma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda USL Reggio Emilia - IRCCS Government |
| Locations | 4 sites (Bologna and 3 other locations) |
| Trial ID | NCT07214324 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter observational effort enrolling adults with MGUS, smoldering multiple myeloma (SMM), and multiple myeloma (MM) alongside older healthy volunteers undergoing joint replacement as controls. The protocol collects blood, bone marrow, and oral microbiome samples for integrated genomic, transcriptomic, immunophenotypic, and microbiome analyses and includes in vitro modeling to probe bone damage and immune dysfunction. By combining these multi-omics datasets, the project aims to identify molecular and immunological markers that distinguish stable precursor conditions from those that progress to symptomatic MM. The ultimate objective is to refine biological risk stratification to inform future preventive or early-intervention strategies.
Who should consider this trial
Good fit: Ideal candidates are adults (over 18) with histologically confirmed MGUS or smoldering multiple myeloma who can provide informed consent and serial biological samples.
Not a fit: Patients with active infections, autoimmune diseases, recent high-dose corticosteroid use, or other conditions that markedly alter immune or microbiome profiles may not benefit from the predictive aims of this project.
Why it matters
Potential benefit: If successful, the approach could enable earlier identification of high-risk individuals and support preventive or closer-monitoring strategies to delay or prevent symptomatic multiple myeloma.
How similar studies have performed: Previous molecular profiling work has identified prognostic markers in multiple myeloma, but combining genomic, immunophenotypic, oral microbiome data and in vitro bone modeling in this integrated way is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bologna and 3 other locations
- Istituto Ortopedico Rizzoli IRCCS — Bologna, Italy (Active_not_recruiting)
- UO Ematologia Azienda Ospedaliero-Universitaria "Policlinico Rodolico San Marco" — Catania, Italy (Active_not_recruiting)
- UOC di Ematologia, Dipartimento di Oncologia, AOU Policlinico "Paolo Giaccone" — Palermo, Italy (Active_not_recruiting)
- S.C Ematologia - Azienda USL IRCCS di Reggio Emilia — Reggio Emilia, Italy (Recruiting)
Study contacts
- Study coordinator: Noemi Puccio
- Email: noemi.puccio@ausl.re.it
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.