Smoldering Multiple Myeloma (SMM)HiFi-MMNCT07069751
A Prospective Multicenter Study of the Effects of Plant-based Diets on Gut Microbiome and Derived Metabolites in Patients Affected by Smoldering Multiple Myeloma
A study testing diet rich in fiber in people with Smoldering Multiple Myeloma (SMM), run by Ciceri Fabio at 5 sites in Italy.
Trial summary
Our overarching hypothesis is that plant-based diets will induce beneficial modifications of the gut microbiota favoring short fatty acid (SCFA)-producing commensals and a more advantageous CD8/Th17 ratio in sMM patients, thus preventing evolution to MM. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Smoldering Multiple Myeloma (SMM)
- What is being tested?
- diet rich in fiber
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 5 sitesItaly
- Study dates
- 31 Oct 2025to 31 May 2029
- Phase
- Interventional
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Confirmed diagnosis of sMM according to IMWG criteria
- Absence of features of symptomatic or active myeloma requiring treatment (myeloma-defining events).
- Aged ≥18 and </= 75 years
- Participant is willing to comply with all study-related procedures.
- ECOG performance status of 0-1.
Who cannot join
- Non-Caucasian subjects. Racial disparities in all stages of the disease characterize MM, and Blacks have an increased MGUS and MM risk and higher mortality rate than Whites.
- Patients that already follow a whole food plant-based diet (≥ 40g/die;ovo-lacto-vegetarian or processed junk food vegan diets are not excluded). These patients likely should already have high SCFA levels in their gut.
- Legume allergy.
- Severe allergies such as anaphylactic shock to nuts (specifically cashews).
- Concurrent participation in weight loss/dietary/exercise programs because of potential conflicts between the concurrent diet and high-fiber diet.
- Enrollment onto any other therapeutic investigational study.
Show all 15Show fewer
- Concurrent pregnancy.
- Ongoing treatment for HBV, HCV or HIV.
- If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications.
- Heavy drinker (defined as >2 drinks per day or >14 drinks per week).
- Current self-reported illicit drug use (e.g., heroin, cocaine not marijuana).
- Subjects that did not accept to sign the informed consent.
- Subjects reporting infectious diseases requiring antibiotic therapy in the previous three months, ongoing antibiotic therapy, or prophylaxis. Antibiotic therapy dramatically modifies the composition of the gut microbiota.
- Subjects affected by autoimmune diseases except for thyroiditis, and patients affected by small and large intestine dysfunctions (i.e., inflammatory bowel disease).
- Gammopathy-associated conditions beyond sMM (e.g. amiloydosis, POEMS, LCDD, etc).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Italy5 sites, 5 recruiting
- Not yet recruiting
Ospedale Giovanni XXIII Policlinico di Bari
Bari
Angelo Vacca, +39 080 5446057, angelo.vacca@uniba.it
Angelo Vacca
- Recruiting
IRCCS Ospedale San Raffaele
Milan, Milano, 20132
Prof. Andrés JM Ferreri, 02-2643- 9396, urc.ul@hsr.it
- Not yet recruiting
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Matteo Claudio Da Vià, 02 55033421, matteo.davia@policlinico.mi.it
Matteo Claudio Da Vià
- Not yet recruiting
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan
Paolo Corradini, 02 2390 2950, paolo.corradini@unimi.it
02 2390 3146
- Not yet recruiting
Azienda Ospedaliero Universitaria di Parma
Parma
Nicola Giuliani, 0521033299, nicola.giuliani@unipr.it
05210703963
About this study
Our overarching hypothesis is that plant-based diets will induce beneficial modifications of the gut microbiota favoring short fatty acid (SCFA)-producing commensals and a more advantageous CD8/Th17 ratio in sMM patients, thus preventing evolution to MM. Goal of this national, prospective, multicenter study is to demonstrate that plant-based diets substantially modify the gut microbiome inducing increased production of SCFAs in patients affected by sMM. The study will involve up to 62 patients affected by sMM. 56 Enrolled and eligible patients will be encouraged to consume a balanced diet rich in fiber for the entire duration of the trial (i.e., 12 weeks). Patients will choose among a list of different diet plans or individual food according to the personal tastes and preference. Free outpatient medical visit will be performed at enrollment and at week 12, and nutritional counseling will be given at the time of enrollment, one month later and on demand. As in line with routine diagnosis and follow-up of for patients affected by sMM, the investigators will collect bone marrow aspirates and peripheral blood at the time of screening, for plasma, serum, and peripheral blood mononuclear cells (PBMCs), while stool samples will be collected immediately before diet initiation. The investigators will also collect stool samples 4 and 12 weeks after diet initiation, and peripheral blood at 12 weeks after study initiation (as per routine clinical follow-up of this patient population). Dietary measurements will be conducted along the entire duration of the nutritional regimen by questionnaires. Biological paired comparison will be conducted between data obtained from samples collected at time 0 and samples collected 4 and 12 weeks later.
- Conditions
- Smoldering Multiple Myeloma (SMM)
- Being tested
- diet rich in fiber
- Keywords
- microbiome, plant-based diets, gut microbiome, smoldering multiple myeloma
- Medical subject headings
- Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diet rich in fiberDietary supplement
Enrolled and eligible patients will be encouraged to consume a balanced diet rich in fiber for the entire duration of the trial (i.e., 12 weeks). Patients will also be encouraged to prolong plant-based diets beyond week 12. Free outpatient medical visit will be performed at enrollment and at week 12, and nutritional counseling will be given at the time of enrollment, one month later and on demand. Dietary measurements will be conducted along the entire duration of the nutritional regimen by questionnaires. In particular, the patient will write for each day of the trial the number associated to the chosen diet plan or food.
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Enrolled and eligible patients will be encouraged to consume a balanced diet rich in fiber for the entire duration of the trial (i.e., 12 weeks). Receives: Dietary Supplement: diet rich in fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of high-fiber diets on mean SCFA concentration in stool samples.
Concentration of at least one among the three main SCFAs (acetate, butyrate and propionate) in stool samples from participants.
Stool samples will be collected at Baseline visit (day 0) and 4 and 12 weeks later.
SCFAs will be measured by targeted nuclear magnetic resonance.
Measured: Stool sampling at day 0, 28 and 84 since high-fiber diet starts.
Secondary outcomes (2)
To evaluate adherence to the diet regimen.
Frequency of participants adhering to the high-fiber diet (≥ 40g/die) at week 4 and 12 weeks since the start.
Measured: Daily dietary measurement by questionnaires and food diary and dietary interview (30 minutes, either in-presence or virtually) at day 0, 28 and 84 since high-fiber diet starts.
To evaluate the effects of high-fiber diets on gut microbiome composition.
Composition of the gut microbiota. Stool samples will be collected at Baseline visit (day 0) and 4 and 12 weeks later.
Composition of the gut microbiota will be obtained by 16S ribosomal RNA sequencing of paired stool samples.
Measured: Stool sampling at day 0, 28 and 84 since high-fiber diet starts.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start31 Oct 2025
- Primary completionJun 2027 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoldering Multiple Myeloma (SMM)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ciceri Fabio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ciceri Fabio, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069751
- Sponsor's protocol ID
- HiFi-MM
- Acronym
- HiFi-MM
- Status last verified
- Mar 2026
- First submitted
- 27 Jun 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Study of the Effects of Plant-based Diets on Gut Microbiome and Derived Metabolites in Patients Affected by Smoldering Multiple Myeloma
- ClinicalTrials.gov ID
- NCT07069751
- Acronym / sponsor ID
- HiFi-MM / HiFi-MM
- Conditions
- Smoldering Multiple Myeloma (SMM)
- Keywords
- microbiome, plant-based diets, gut microbiome, smoldering multiple myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Ciceri FabioUniversity, hospital or other
- Study start
- 31 Oct 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 17 Jul 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.
Our overarching hypothesis is that plant-based diets will induce beneficial modifications of the gut microbiota favoring short fatty acid (SCFA)-producing commensals and a more advantageous CD8/Th17 ratio in sMM patients, thus preventing evolution to MM. Goal of this national, prospective, multicenter study is to demonstrate that plant-based diets substantially modify the gut microbiome inducing increased production of SCFAs in patients affected by sMM. The study will involve up to 62 patients affected by sMM. 56 Enrolled and eligible patients will be encouraged to consume a balanced diet rich in fiber for the entire duration of the trial (i.e., 12 weeks). Patients will choose among a list of different diet plans or individual food according to the personal tastes and preference. Free outpatient medical visit will be performed at enrollment and at week 12, and nutritional counseling will be given at the time of enrollment, one month later and on demand. As in line with routine diagnosis and follow-up of for patients affected by sMM, the investigators will collect bone marrow aspirates and peripheral blood at the time of screening, for plasma, serum, and peripheral blood mononuclear cells (PBMCs), while stool samples will be collected immediately before diet initiation. The investigators will also collect stool samples 4 and 12 weeks after diet initiation, and peripheral blood at 12 weeks after study initiation (as per routine clinical follow-up of this patient population). Dietary measurements will be conducted along the entire duration of the nutritional regimen by questionnaires. Biological paired comparison will be conducted between data obtained from samples collected at time 0 and samples collected 4 and 12 weeks later.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Dietary Supplement: diet rich in fiberEnrolled and eligible patients will be encouraged to consume a balanced diet rich in fiber for the entire duration of the trial (i.e., 12 weeks). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Confirmed diagnosis of sMM according to IMWG criteria
- Absence of features of symptomatic or active myeloma requiring treatment (myeloma-defining events).
- Aged ≥18 and </= 75 years
- Participant is willing to comply with all study-related procedures.
Key exclusion criteria (15 listed)
- Non-Caucasian subjects. Racial disparities in all stages of the disease characterize MM, and Blacks have an increased MGUS and MM risk and higher mortality rate than Whites.
- Patients that already follow a whole food plant-based diet (≥ 40g/die;ovo-lacto-vegetarian or processed junk food vegan diets are not excluded). These patients likely should already have high SCFA levels in their gut.
- Legume allergy.
- Severe allergies such as anaphylactic shock to nuts (specifically cashews).
- Concurrent participation in weight loss/dietary/exercise programs because of potential conflicts between the concurrent diet and high-fiber diet.
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 |
|---|---|---|
| diet rich in fiberEnrolled and eligible patients will be encouraged to consume a balanced diet rich in fiber for the entire duration of the trial (i.e., 12 weeks). Patients will also be encouraged to prolong plant-based diets beyond week 12. Free outpatient medical visit will be performed at enrollment and at week 12, and nutritional counseling will be given at the time of enrollment, one month later and on demand. Dietary measurements will be conducted along the entire duration of the nutritional regimen by questionnaires. In particular, the patient will write for each day of the trial the number associated to the chosen diet plan or food. | Dietary supplement | Treatment arm |
Primary outcome
To evaluate the effects of high-fiber diets on mean SCFA concentration in stool samples.
Time frame: Stool sampling at day 0, 28 and 84 since high-fiber diet starts.
Concentration of at least one among the three main SCFAs (acetate, butyrate and propionate) in stool samples from participants. Stool samples will be collected at Baseline visit (day 0) and 4 and 12 weeks later. SCFAs will be measured by targeted nuclear magnetic resonance.
2 secondary outcomes
To evaluate adherence to the diet regimen.
Time frame: Daily dietary measurement by questionnaires and food diary and dietary interview (30 minutes, either in-presence or virtually) at day 0, 28 and 84 since high-fiber diet starts.
To evaluate the effects of high-fiber diets on gut microbiome composition.
Time frame: Stool sampling at day 0, 28 and 84 since high-fiber diet starts.
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 3 Apr 2026.
Related trials for Smoldering Multiple Myeloma (SMM)
RecruitingPhase 3
A Study to Compare Linvoseltamab and Daratumumab Treatment in High-Risk Smoldering Multiple Myeloma (HR-SMM)
High Risk Smoldering Multiple Myeloma (HR-SMM)
RecruitingObservational study
The Indiana Myeloma Registry
Plasma Cell Dyscrasias
RecruitingObservational study
Screening for AL Amyloidosis in Smoldering Multiple Myeloma
Smoldering Multiple Myeloma
RecruitingPhase 2
Isatuximab and Iberdomide as Immunotherapy for High Risk in Smouldering Myeloma
Smouldering Myeloma
RecruitingObservational study
Observational Prospective Research Study In Monoclonal Gammopathies leadINg to Myeloma
Monoclonal Gammopathy of Undetermined Significance, Smoldering Plasma Cell Myeloma
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diet rich in fiber in people with Smoldering Multiple Myeloma (SMM), run by Ciceri Fabio at 5 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 6 inclusion and 15 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 3 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 5 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 Tommaso Perini (02-26436615, ciceri.clinicaltrials@hsr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of high-fiber diets on mean SCFA concentration in stool samples. (time frame: Stool sampling at day 0, 28 and 84 since high-fiber diet starts.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Apr 2026.