Tests a plant-based diet and supplements in people with early myeloma-related blood conditions
Compares a plant-based diet, supplements and placebo in adults with early blood changes.
Plain-language title generated from the registry record
Registry title: A Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)
Key facts
- Where
- Atlanta, Basking Ridge, Commack, Harrison, Middletown, Montvale, New York, and Uniondale, United StatesSee the 8 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with MGUS or smoldering multiple myeloma who are interested in learning to cook plant-based recipes.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Confirmed MGUS or smoldering multiple myeloma (SMM). Set blood or bone marrow levels are needed, depending on the type. ECOG performance status of 0-3.
- Earlier treatment
- People already taking curcumin or omega 3 supplements must be willing to stop them for the whole study. People in another therapeutic investigational study, now or in the last 180 days, cannot join.
- Biomarker or test result
- Depends on the type. M spike of 0.2 g/dL or more, or 10% or more plasma cells in the bone marrow. Light chain types need involved light chain of 10 mg/dL or more, or 10% or more bone marrow plasma cells. IgA needs a level above 350 mg/dL and an abnormal immunofixation. IgD needs a level above 50 mg/dL and an abnormal immunofixation.
Main reasons for not taking part
- Already follows a whole foods plant-based diet
- Allergy to legumes, or severe allergy such as anaphylactic shock to nuts (cashews)
- Taking part in a weight loss, diet or exercise program
- Pregnant now
- Positive HBV, HCV or HIV PCR test, unless treated and the viral load is undetectable
Read by machine on 9 November 2026.
Where in United States
- Emory University (Data Collection Only)Atlanta, United StatesTaking people
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Basking Ridge, United StatesTaking people
- Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)Commack, United StatesTaking people
- Memorial Sloan Kettering Westchester (All Protocol Activities)Harrison, United StatesTaking people
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Middletown, United StatesTaking people
- Memorial Sloan Kettering Bergen (All Protocol Activities)Montvale, United StatesTaking people
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, United StatesTaking people
- Memorial Sloan Kettering Nassau (All Protocol Activities)Uniondale, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Memorial Sloan Kettering Cancer Center
- Trial code
- NCT05640843
- Record updated
- 16 April 2026
- Original description
The researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. All participants will have monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). We will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.Read full original descriptionShow less
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
The researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. All participants will have monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). We will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.
Inclusion: 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: Concurrent participation in weight loss/dietary/exercise programs; Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date; Concurrent pregnancy; Current self-reported illicit drug use (eg heroin, cocaine not marijuana); Legume allergy; Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals; Mental impairment leading to inability to cooperate; Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll; History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment; Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded); ≥ 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); Plan for prolonged travel during the study that would preclude adherence to prescribed diets; If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.