Plant-based, high-fiber diets and the gut microbiome in smoldering 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 intervention in Italy enrolling up to 62 patients with smoldering multiple myeloma, with 56 eligible participants encouraged to follow a balanced, fiber-rich plant-based diet for 12 weeks. Participants choose from several diet plans or individual foods to match personal preferences and receive nutritional counseling at enrollment, at one month, and on demand. Clinical visits and sample collection occur at enrollment and at week 12 to analyze gut microbiome composition, short-chain fatty acid production, and immune markers such as CD8/Th17 ratios. The protocol aims to document microbiome shifts associated with increased SCFA production and explore whether these changes correlate with biomarkers linked to progression risk.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Participant is willing and able to give informed consent for participation in the study.
2. Confirmed diagnosis of sMM according to IMWG criteria
3. Absence of features of symptomatic or active myeloma requiring treatment (myeloma-defining events).
4. Aged ≥18 and \</= 75 years
5. Participant is willing to comply with all study-related procedures.
6. ECOG performance status of 0-1.

Exclusion Criteria:

1. 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.
2. 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.
3. Legume allergy.
4. Severe allergies such as anaphylactic shock to nuts (specifically cashews).
5. Concurrent participation in weight loss/dietary/exercise programs because of potential conflicts between the concurrent diet and high-fiber diet.
6. Enrollment onto any other therapeutic investigational study.
7. Concurrent pregnancy.
8. Ongoing treatment for HBV, HCV or HIV.
9. 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.
10. Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week).
11. Current self-reported illicit drug use (e.g., heroin, cocaine not marijuana).
12. Subjects that did not accept to sign the informed consent.
13. 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.
14. Subjects affected by autoimmune diseases except for thyroiditis, and patients affected by small and large intestine dysfunctions (i.e., inflammatory bowel disease).
15. Gammopathy-associated conditions beyond sMM (e.g. amiloydosis, POEMS, LCDD, etc).

Where it's running

• IRCCS Ospedale San Raffaele
  Milan, Milano, Italy Recruiting
• Ospedale Giovanni XXIII Policlinico di Bari
  Bari, Italy Not yet recruiting
• Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
  Milan, Italy Not yet recruiting
• Fondazione IRCCS Istituto Nazionale dei Tumori
  Milan, Italy Not yet recruiting
• Azienda Ospedaliero Universitaria di Parma
  Parma, Italy Not yet recruiting

Study contacts

• Study coordinator: Tommaso Perini
• Email: ciceri.clinicaltrials@hsr.it
• Phone: 02-26436615

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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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.