A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM)

Last updated: April 11, 2025
Sponsor: Memorial Sloan Kettering Cancer Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Platelet Disorders

Lymphoproliferative Disorders

Leukemia

Treatment

Curcumin

Probiotic

Omega-3

Clinical Study ID

NCT06055894
23-116
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is 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). 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 (anytime 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)

  • Concurrent use of prescription weight loss (such as semaglutides and tirzepatides)and/or therapeutic myeloma drugs such as daratumumab, lenalidomide, etc.) within 12weeks of consent

  • Mental impairment leading to inability to cooperate

  • Enrollment onto any other therapeutic investigational study

  • Concurrent pregnancy

  • Patients on full dose anticoagulation

  • ≥ Grade 2 electrolyte (sodium and potassium) 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 abilityof the patient to complete the study safely

  • Current self reported heavy alcohol use (defined as >2 drinks per day or >14 drinksper week)

  • Current self-reported illicit drug use (except inhaled marijuana, vaping orcigarette smoking. Oral marijuana/THC excluded or must stop >2 weeks prior.)

  • 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: Curcumin
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

    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 Suffolk - Commack (Limited 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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