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)

Last updated: March 26, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Cancer/tumors

Leukemia

Treatment

Placebo supplements

Whole Foods Plant-based Diet

Algae omega 3

Clinical Study ID

NCT05640843
22-175
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 notrequired)

  • If IgA MGUS/SMM then an IgA level >350 mg/dL and an abnormal immunofixation isrequired (M spike criteria not required).

  • If IgD MGUS/SMM then an IgD level >50 mg/dL and an abnormal immunofixation isrequired (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

Exclusion Criteria:

  • Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian orprocessed junk food vegan diets are not excluded)

  • Legume allergy

  • Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanutsare 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 onceundetectable viral load patients may enroll

  • ≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolvedbefore enrolling on study)

  • If in the opinion of the investigator there maybe any concerns regarding the abilityof 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)

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: Placebo supplements
Phase:
Study Start date:
November 29, 2022
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Emory University (Data Collection Only)

    Atlanta, Georgia 30322
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

    Commack, New York 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York 11553
    United States

    Active - Recruiting

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