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) NUTRIVENTION3

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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)

Additional Trial Information

Phase 0

Enrollment: 150 patients (estimated)

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Trial Locations

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New York

Memorial Sloan Kettering Cancer Center

New York, NY

Open and Accepting
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