Multi-omics profiling to predict progression from MGUS and smoldering myeloma to symptomatic multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• S.C Ematologia - Azienda USL IRCCS di Reggio Emilia
  Reggio Emilia, Italy Recruiting
• 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

Study contacts

• Study coordinator: Noemi Puccio
• Email: noemi.puccio@ausl.re.it

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.