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)

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.

Conditions

Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance

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Study Overview

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Study Details

Study overview

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.

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 (NUTRIVENTION3) Study

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)

Condition
Multiple Myeloma
Intervention / Treatment

-

Contacts and Locations

Basking Ridge

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge, New Jersey, United States, 07920

Middletown

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown, New Jersey, United States, 07748

Montvale

Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale, New Jersey, United States, 07645

Commack

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities), Commack, New York, United States, 11725

Harrison

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison, New York, United States, 10604

New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York, New York, United States, 10065

Uniondale

Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale, New York, United States, 11553

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Memorial Sloan Kettering Cancer Center,

Urvi A Shah, MD, MS, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

2026-11