Comparing a plant-based diet with supplements and placebo for people with MGUS or smoldering multiple myeloma
A Randomized Placebo Controlled Study of a Plant-Based Dietary Versus Supplement Versus Placebo Intervention in Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION-3) Study
This study is testing whether a plant-based diet combined with certain supplements can change butyrate levels in people with MGUS or smoldering multiple myeloma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 8 sites (Atlanta, Georgia and 7 other locations) |
| Trial ID | NCT05640843 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a confirmed diagnosis of MGUS or SMM who are interested in adopting a plant-based diet.
Not a fit: Patients who are already following a whole foods plant-based diet or have severe allergies to legumes or nuts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a dietary intervention that may improve health outcomes for patients with MGUS or SMM.
How similar studies have performed: While dietary interventions in cancer care are being explored, this specific approach comparing a plant-based diet with supplements in MGUS or SMM is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Atlanta, Georgia and 7 other locations
- 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)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.