A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)

Last updated: November 12, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lymphoproliferative Disorders

Multiple Myeloma

Bone Diseases

Treatment

Omega-3

Whole food, plant-based diet (WFPBD)

Curcumin

Clinical Study ID

NCT06055894
23-116
  • Ages > 18
  • All Genders

Study Summary

The researchers are going this to look at how butyrate levels change in participants' stool after they are on a plant-based diet or dietary supplements (omega-3, curcumin or probiotics) for 2 weeks. All participants will have smoldering multiple myeloma (SMM) or monoclonal gammopathy of undetermined significance (MGUS). The researchers will compare how the different dietary changes affect butyrate levels in participants' stool.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed prior diagnosis MGUS or of smoldering myeloma (any time prior). However,confirmation of diagnosis must be documented in their last local oncologist clinicnote within 6 months prior to study enrollment.

  • Age ≥18 years

  • Willingness to comply with all study-related procedures

  • Physically able to complete requirements for the study or has someone to assist withthe requirements (such as meal preparation, stool shipment and survey completion)

  • Interested in learning to cook plant-based recipes

  • Access to smart mobile phone or device with camera and ability to download Keenoaapp

  • Be residing within the United States for the study duration.

  • English speaking or a family member or caregiver who speaks English and is able toassist with the surveys and phone based Keenoa app.

Exclusion

Exclusion Criteria:

  • Taking any supplements other than vitamin D, iron, vitamin B12, potassium,magnesium, calcium or those needed for a medical indication must be reviewed by PI.If patient is on a supplement (including curcumin, probiotic, omega3) they must stopthese for 2 weeks prior to enrollment on study.

  • Patients that already follow a whole foods plant based diet (ovo-lactovegetarian orprocessed junk food vegan diets are not excluded). This will be per researchdietitian evaluation and discretion after nutrition screening.

  • Legume allergy

  • Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such ascashews

  • Concurrent participation in weight loss/dietary trials or defined programs (thatrequire specified diets/supplements on the program). Patients on weight loss drugsare eligible.

  • Mental impairment leading to inability to cooperate

  • Enrollment onto any other therapeutic investigational study

  • Concurrent pregnancy

  • Patients on full dose anticoagulation

  • If in the opinion of the investigator there maybe any concerns regarding the abilityof the patient to complete the study safely

  • Current self-reported heavy alcohol use and is defined as >5 drinks per day or >15drinks per week

  • Current self-reported illicit drug use (except inhaled marijuana, vaping orcigarette smoking or medical marijuana.

  • Has a condition requiring antibiotics within 14 days of study interventionadministration.

  • Plan for travel during the study that would preclude adherence to prescribed diets

  • History of active inflammatory bowel disease or major gastrointestinal surgery (notincluding appendectomy or cholecystectomy) within 3 months of enrollment or anyhistory of total colectomy, or bariatric surgery (bariatric surgery which does notdisrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, arepermitted)

Study Design

Total Participants: 200
Treatment Group(s): 4
Primary Treatment: Omega-3
Phase:
Study Start date:
September 20, 2023
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge, New Jersey 07920
    United States

    Site Not Available

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown, New Jersey 07748
    United States

    Site Not Available

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale, New Jersey 07645
    United States

    Site Not Available

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

    Basking Ridge 5095409, New Jersey 5101760 07920
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Monmouth (All Protocol Activities)

    Middletown 5101170, New Jersey 5101760 07748
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Bergen (All Protocol Activities)

    Montvale 5101361, New Jersey 5101760 07645
    United States

    Active - Recruiting

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

    Commack, New York 11725
    United States

    Active - Recruiting

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

    Commack, New York 11725
    United States

    Site Not Available

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison, New York 10604
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York, New York 10065
    United States

    Site Not Available

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale, New York 11553
    United States

    Site Not Available

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

    Commack 5113412, New York 5128638 11725
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Westchester (All Protocol Activities)

    Harrison 5120095, New York 5128638 10604
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)

    New York 5128581, New York 5128638 10065
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Nassau (All Protocol Activities)

    Uniondale 5141927, New York 5128638 11553
    United States

    Active - Recruiting

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