Comparing a plant-based diet with supplements and placebo for people with MGUS or 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 study investigates the effects of a plant-based diet on butyrate levels in individuals diagnosed with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). Participants will follow a whole foods plant-based diet for at least 12 weeks, while also receiving either omega-3 fatty acid and curcumin supplements or a placebo. The primary focus is to compare the changes in butyrate levels in stool samples among the different groups. The study aims to provide insights into dietary impacts on this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Confirmed diagnosis of MGUS or SMM
* If non light chain MGUS/SMM then M spike must be either ≥ 0.2 g/dL or BM PC ≥10% (both not required)
* If light chain MGUS/SMM then involved must be ≥10 mg/dL or BM PC ≥10% (both not required)
* If IgA MGUS/SMM then an IgA level \>350 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
* If IgD MGUS/SMM then an IgD level \>50 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
* Age ≥18 years
* Willingness to comply with all study-related procedures
* ECOG performance status of 0-3
* Interested in learning to cook plant based recipes

Exclusion Criteria:

* Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)
* Legume allergy
* Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.
* Concurrent participation in weight loss/dietary/exercise programs
* Mental impairment leading to inability to cooperate
* Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date
* Concurrent pregnancy
* Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll
* ≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)
* 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 (eg heroin, cocaine not marijuana)
* Plan for prolonged travel during the study that would preclude adherence to prescribed diets
* History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment
* If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.

Where it's running

• Emory University (Data Collection Only)
  Atlanta, Georgia, United States Recruiting
• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting

Study contacts

• Principal investigator: Urvi A Shah, MD, MS — Memorial Sloan Kettering Cancer Center
• Study coordinator: Urvi A Shah, MD, MS
• Email: ShahNutrivention@mskcc.org
• Phone: 646-608-3713

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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.