Clinical trial · Observational
Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Monoclonal Gammopathy of Undetermined Significance (MGUS) | Monoclonal Gammopathy of Undetermined Significance | ALIAS | 0.90 |
| Multiple Myeloma (MM) | Multiple Myeloma | CURATED_EXACT | 0.85 |
| Smoldering Multiple Myeloma (SMM) | Smoldering Multiple Myeloma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Collection of biological material | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- MGUS, SMM and MM patients
- description
- Patients with monoclonal gammopathy of undeterminated significance, smoldering multiple myeloma, or multiple myeloma
- interventionNames
- Other: Collection of biological material
- label
- Healthy volunteers
- description
- Patients with a clinical and radiological diagnosis of osteoarthritis who undergo endo or arthro-prosthesis surgery
- interventionNames
- Other: Collection of biological material
Primary outcomes (3)
- measure
- Bone marrow and peripheral blood immunophenotypic characterization
- timeFrame
- up to 24 months
- description
- Multiparametric flow cytometry of bone marrow CD138- cells and peripheral blood mononuclear cells (PBMCs) to define immune subsets and to assess alterations associated with monoclonal gammopathies progression.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (7)
- BACKGROUNDRossi M, Altomare E, Botta C, Gallo Cantafio ME, Sarvide S, Caracciolo D, Riillo C, Gaspari M, Taverna D, Conforti F, Critelli P, Bertucci B, Iannone M, Polera N, Scumaci D, Arbitrio M, Amodio N, Di Martino MT, Paiva B, Tagliaferri P, Tassone P. miR-21 antagonism abrogates Th17 tumor promoting functions in multiple myeloma. Leukemia. 2021 Mar;35(3):823-834. doi: 10.1038/s41375-020-0947-1. Epub 2020 Jul 6. PMID 32632096
- BACKGROUNDLeone P, Solimando AG, Malerba E, Fasano R, Buonavoglia A, Pappagallo F, De Re V, Argentiero A, Silvestris N, Vacca A, Racanelli V. Actors on the Scene: Immune Cells in the Myeloma Niche. Front Oncol. 2020 Oct 29;10:599098. doi: 10.3389/fonc.2020.599098. eCollection 2020. PMID 33194767
- BACKGROUNDBolli N, Maura F, Minvielle S, Gloznik D, Szalat R, Fullam A, Martincorena I, Dawson KJ, Samur MK, Zamora J, Tarpey P, Davies H, Fulciniti M, Shammas MA, Tai YT, Magrangeas F, Moreau P, Corradini P, Anderson K, Alexandrov L, Wedge DC, Avet-Loiseau H, Campbell P, Munshi N. Genomic patterns of progression in smoldering multiple myeloma. Nat Commun. 2018 Aug 22;9(1):3363. doi: 10.1038/s41467-018-05058-y. PMID 30135448
- BACKGROUNDZiccheddu B, Da Via MC, Lionetti M, Maeda A, Morlupi S, Dugo M, Todoerti K, Oliva S, D'Agostino M, Corradini P, Landgren O, Iorio F, Pettine L, Pompa A, Manzoni M, Baldini L, Neri A, Maura F, Bolli N. Functional Impact of Genomic Complexity on the Transcriptome of Multiple Myeloma. Clin Cancer Res. 2021 Dec 1;27(23):6479-6490. doi: 10.1158/1078-0432.CCR-20-4366. Epub 2021 Sep 15. PMID 34526359
- BACKGROUNDRobiou du Pont S, Cleynen A, Fontan C, Attal M, Munshi N, Corre J, Avet-Loiseau H. Genomics of Multiple Myeloma. J Clin Oncol. 2017 Mar 20;35(9):963-967. doi: 10.1200/JCO.2016.70.6705. Epub 2017 Feb 13. PMID 28297630
- BACKGROUNDMorgan GJ, Walker BA, Davies FE. The genetic architecture of multiple myeloma. Nat Rev Cancer. 2012 Apr 12;12(5):335-48. doi: 10.1038/nrc3257.