Monoclonal Gammopathy of Undetermined Significance (MGUS)PNRR-2022-1237NCT07214324
Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution
An observational study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM), run by Azienda USL Reggio Emilia - IRCCS at 4 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), Multiple Myeloma (MM)
- What is being tested?
- Collection of biological material
- How many people
- 60 participants
- Where
- 4 sitesItaly
- Study dates
- 17 Mar 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with MGUS, SMM, or MM (with or without bone lytic lesions), as well as patient with osteoarthritis undergoing joint surgery (endoprosthesis or artroplasty) (Healty Volunteers)
Who may be able to join
- 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
Show all 9Show fewer
- Diagnosis of osteoarthritis (OA)
- Scheduled for hospitalization for surgical treatment of OA (endoprosthesis or arthroplasty)
- Willing and able to provide written informed consent
Who cannot join
- 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:
Show all 11Show fewer
- 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)
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Noemi Puccio contact
Italy4 sites, 1 recruiting
- Active, not recruiting
Istituto Ortopedico Rizzoli IRCCS
Bologna
- Active, not recruiting
UO Ematologia Azienda Ospedaliero-Universitaria "Policlinico Rodolico San Marco"
Catania
- Active, not recruiting
UOC di Ematologia, Dipartimento di Oncologia, AOU Policlinico "Paolo Giaccone"
Palermo
- Recruiting
S.C Ematologia - Azienda USL IRCCS di Reggio Emilia
Reggio Emilia
Cecilia Fabiano, cecilia.fabiano@ausl.re.it
Barbara Gamberi, MD, barbara.gamberi@ausl.re.it
About this study
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.
Read the detailed description
Multiple myeloma (MM) is a hematologic malignancy characterized by the clonal proliferation of antibody-secreting plasma cells in the bone marrow. It accounts for approximately 10% of all blood cancers, with an incidence of 3-5per 100.000 individuals in Westen countries. MM is an incurable disease that leads to severe bone destruction and fractures due to the abnormal interaction between malignant plasma cells and the bone marrow microenvironment. Although new therapies have improved survival, MM remains a complex and genetically heterogeneous disease. Genomic instability is a hallmark of MM and includes both chromosomal abnormalities and gene mutations. Tumors may presenta s hyperdiploid - with multiple trisomies - or non-hyperdiploid, often involving translocations at the immunoglobulin heavy chain locus (IGH). These genetic differences impact prognosis. Additional recurrent alterations, such as deletions (13q, 17q), gains (1q), and mutations in genes like KRAS, NRAS, TP53, and BRAF, further illustrate the disease's biological diversity. Molecular profiling techniques, such as RNA sequencing and gene expression arrays, have identified gene expression patterns that correlate with prognosis, though only a few are currently used in clinical practice. MM is consistently preceded by two asymptomatic precursor conditions: monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). These conditions are prevalent in older adults and share many molecular features with symptomatic MM, yet only a small fraction of cases progress annually - about 1% for MGUS and 10% for SMM. Disease evolution appears to depend not only on intrinsic genetic changes but also on interactions with the bone marrow microenvironment, which includes stromal cells, dendritic cells, T cells (especially Th17), NK cells and myeloid-derived suppressors cells. Immune dysfunction, antigen presentation defects, expansion of immunosuppressive cells, and high levels of inhibitory cytokines contribute to the emergence of an immunosuppressive niche that enables myeloma cells to escape immune surveillance and progress. Immunomodulatory drugs (ImiDs) and monoclonal antibodies, which can reactivate immune responses, are therefore central to treatment strategies. Recent evidence also suggests a link between the microbiota and disease progression. In experimental models, alterations in gut microbiota have been shown to affect immune responses, influencing disease onset. Currently available prognostic tools mainly reflect tumor burden rather than underlying biology. As such, they fail to accurately predict disease progression.
- Conditions
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), Multiple Myeloma (MM)
- Being tested
- Collection of biological material
- Keywords
- plasma cells, multi-omics, biomarkers, bone marrow microenvironment, microbiome
- Medical subject headings
- Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of biological materialOther
For MGUS, SMM and MM patients, biological material (bone marrow aspirate, bone marrow biopsy, peripheral blood) consists exclusively of left-over samples obtained during routine diagnostic procedures and clinical practice management of their disease.
For healthy volunteers, biological material includes waste bone tissue obtained during orthopedic surgery (endo- or arthro-prosthesis) and peripheral blood collected for research purposes.
Both cohort of patient will be asked to donate gingival crevicular fluid (GCF) (this is a non-invasive procedure with no associated risks).
| Study group | Role | What they receive |
|---|---|---|
| MGUS, SMM and MM patients | Patients with monoclonal gammopathy of undeterminated significance, smoldering multiple myeloma, or multiple myeloma Receives: Other: Collection of biological material | |
| Healthy volunteers | Patients with a clinical and radiological diagnosis of osteoarthritis who undergo endo or arthro-prosthesis surgery Receives: Other: Collection of biological material |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone marrow and peripheral blood immunophenotypic characterization
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.
Measured: up to 24 months
Genomic and transcriptomic profiling of plasma cell
Next-generation sequencing (NGS) analysis of bone marrow CD138+ plasma cells, including targeted 14-gene mutation panels, copy number alterations by ultra-low-pass whole genome sequencing, RNA sequencing, and single-cell transcriptomics to identify molecular signatures of disease evolution.
Measured: Up to 24 months
Single-cell and spatial transcriptomic analyses
Single-cell RNAseq, antibody-based sequencing (ABseq), TCR sequencing, and spatial transcriptomics on bone marrow biopsies to characterize clonal heterogeneity, cell-cell interactions, and microenvironmental influences during progression from MGUS/SMM to Multiple Myeloma.
Measured: up to 24 months
Secondary outcomes (2)
Evaluation of oral microbiome composition
Sequencing-based profiling (16S rRNA) of DNA extracted from gingival crevicular fluid (GCF) samples of patients and healthy volunteers to investigate oral microbiome dysbiosis and its association with immune dysfunction and disease progression.
Measured: up to 24, months
Functional validation of genetic profiles in osteolytic disease
Use of CRISPR-Cas9 screening in myeloma cell lines and dynamic 3D co-culture models (osteoblasts, osteoclasts, immune and stromal cells) to evaluate the role of specific molecular pathways in osteolytic lesion development and immune impairment.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start17 Mar 2025
- Primary completion12 Aug 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Monoclonal Gammopathy of Undetermined Significance (MGUS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCS
- Sponsor type
- Other government
- Collaborators
- European Union, Ministero della Salute, Italy
- Responsible party
- Sponsor
- Investigators
- Antonino Neri, MD, PhD, Study chair, Azienda USL Reggio Emilia - IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214324
- Sponsor's protocol ID
- 849/2022/TESS/IRCCSRE
- Acronym
- PNRR-2022-1237
- Status last verified
- Oct 2025
- First submitted
- 2 Oct 2025
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Rossi 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.
PubMed 32632096Leone 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.
PubMed 33194767Bolli 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.
PubMed 30135448Ziccheddu 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.
PubMed 34526359Robiou 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.
PubMed 28297630Morgan 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.
PubMed 22495321Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. No abstract available.
PubMed 21410373
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Multi-omics Analysis to Predict Monoclonal Gammopathies Clinical Evolution
- ClinicalTrials.gov ID
- NCT07214324
- Acronym / sponsor ID
- PNRR-2022-1237 / 849/2022/TESS/IRCCSRE
- Conditions
- Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), Multiple Myeloma (MM)
- Keywords
- plasma cells, multi-omics, biomarkers, bone marrow microenvironment, microbiome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda USL Reggio Emilia - IRCCSOther government
- Collaborators
- European Union, Ministero della Salute, Italy
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- 12 Aug 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multiple myeloma (MM) is a hematologic malignancy characterized by the clonal proliferation of antibody-secreting plasma cells in the bone marrow. It accounts for approximately 10% of all blood cancers, with an incidence of 3-5per 100.000 individuals in Westen countries. MM is an incurable disease that leads to severe bone destruction and fractures due to the abnormal interaction between malignant plasma cells and the bone marrow microenvironment. Although new therapies have improved survival, MM remains a complex and genetically heterogeneous disease. Genomic instability is a hallmark of MM and includes both chromosomal abnormalities and gene mutations. Tumors may presenta s hyperdiploid - with multiple trisomies - or non-hyperdiploid, often involving translocations at the immunoglobulin heavy chain locus (IGH). These genetic differences impact prognosis. Additional recurrent alterations, such as deletions (13q, 17q), gains (1q), and mutations in genes like KRAS, NRAS, TP53, and BRAF, further illustrate the disease's biological diversity. Molecular profiling techniques, such as RNA sequencing and gene expression arrays, have identified gene expression patterns that correlate with prognosis, though only a few are currently used in clinical practice. MM is consistently preceded by two asymptomatic precursor conditions: monoclonal gammopathy of undetermined significance (MGUS) and smoldering multiple myeloma (SMM). These conditions are prevalent in older adults and share many molecular features with symptomatic MM, yet only a small fraction of cases progress annually - about 1% for MGUS and 10% for SMM. Disease evolution appears to depend not only on intrinsic genetic changes but also on interactions with the bone marrow microenvironment, which includes stromal cells, dendritic cells, T cells (especially Th17), NK cells and myeloid-derived suppressors cells. Immune dysfunction, antigen presentation defects, expansion of immunosuppressive cells, and high levels of inhibitory cytokines contribute to the emergence of an immunosuppressive niche that enables myeloma cells to escape immune surveillance and progress. Immunomodulatory drugs (ImiDs) and monoclonal antibodies, which can reactivate immune responses, are therefore central to treatment strategies. Recent evidence also suggests a link between the microbiota and disease progression. In experimental models, alterations in gut microbiota have been shown to affect immune responses, influencing disease onset. Currently available prognostic tools mainly reflect tumor burden rather than underlying biology. As such, they fail to accurately predict disease progression.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGUS, SMM and MM patients | – | Other: Collection of biological materialPatients with monoclonal gammopathy of undeterminated significance, smoldering multiple myeloma, or multiple myeloma |
| Healthy volunteers | – | Other: Collection of biological materialPatients with a clinical and radiological diagnosis of osteoarthritis who undergo endo or arthro-prosthesis surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with MGUS, SMM, or MM (with or without bone lytic lesions), as well as patient with osteoarthritis undergoing joint surgery (endoprosthesis or artroplasty) (Healty Volunteers)
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (11 listed)
- Patients:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collection of biological materialFor MGUS, SMM and MM patients, biological material (bone marrow aspirate, bone marrow biopsy, peripheral blood) consists exclusively of left-over samples obtained during routine diagnostic procedures and clinical practice management of their disease. For healthy volunteers, biological material includes waste bone tissue obtained during orthopedic surgery (endo- or arthro-prosthesis) and peripheral blood collected for research purposes. Both cohort of patient will be asked to donate gingival crevicular fluid (GCF) (this is a non-invasive procedure with no associated risks). | Other | Healthy volunteers, MGUS, SMM and MM patients |
Primary outcome
Bone marrow and peripheral blood immunophenotypic characterization
Time frame: up to 24 months
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.
Genomic and transcriptomic profiling of plasma cell
Time frame: Up to 24 months
Next-generation sequencing (NGS) analysis of bone marrow CD138+ plasma cells, including targeted 14-gene mutation panels, copy number alterations by ultra-low-pass whole genome sequencing, RNA sequencing, and single-cell transcriptomics to identify molecular signatures of disease evolution.
Single-cell and spatial transcriptomic analyses
Time frame: up to 24 months
Single-cell RNAseq, antibody-based sequencing (ABseq), TCR sequencing, and spatial transcriptomics on bone marrow biopsies to characterize clonal heterogeneity, cell-cell interactions, and microenvironmental influences during progression from MGUS/SMM to Multiple Myeloma.
2 secondary outcomes
Evaluation of oral microbiome composition
Time frame: up to 24, months
Functional validation of genetic profiles in osteolytic disease
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 32632096Rossi 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.
- Background: PubMed 33194767Leone 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.
- Background: PubMed 30135448Bolli 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.
- Background: PubMed 34526359Ziccheddu 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.
- Background: PubMed 28297630Robiou 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.
- Background: PubMed 22495321Morgan 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.
- Background: PubMed 21410373Palumbo A, Anderson K. Multiple myeloma. N Engl J Med. 2011 Mar 17;364(11):1046-60. doi: 10.1056/NEJMra1011442. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Noemi Puccio contact
Antonino Neri, MD, PhD study chair
Azienda USL Reggio Emilia - IRCCS
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM), run by Azienda USL Reggio Emilia - IRCCS at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noemi Puccio (noemi.puccio@ausl.re.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone marrow and peripheral blood immunophenotypic characterization (time frame: up to 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07214324, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026.