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Diet and Supplements for Smoldering Multiple Myeloma or MGUS

This study is looking at how a plant-based diet or certain dietary supplements affect your gut health if you have smoldering multiple myeloma (SMM) or monoclonal gammopathy of undetermined significance (MGUS). You could receive Omega-3, Curcumin, Probiotics, or a whole food, plant-based diet for two weeks. Researchers will measure levels of butyrate, a substance made by gut bacteria, in your stool to see how these changes impact your body. To join, you must be at least 18 years old and have a confirmed diagnosis of MGUS or SMM. The study is currently recruiting 200 participants.

Study design
This interventional study plans to enroll 200 participants. It is not specified if it is randomized or blinded.
What's involved
You would follow a specific diet or take supplements for two weeks. Stool samples will be collected at the end of this period.
Compensation
Not stated in the trial record.
Follow-up
Your butyrate levels will be measured at 2 weeks, which is the primary endpoint.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06055894

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

Recruiting
NAAges 18+InterventionalPrevention
Memorial Sloan Kettering Cancer Center
~200 participants
Updated 2025-11-13 on ClinicalTrials.gov
What's tested:Omega-3CurcuminProbioticWhole food, plant-based diet (WFPBD)

At a glance

Recruiting sites
7 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative abundance of stool butyrate producers at 2 weeks
Measured over at 2 weeks

Conditions

Multiple Myeloma, Smoldering
Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance

Explore related trials

Monoclonal Gammopathy of Undetermined SignificanceSmoldering Multiple Myeloma

Where it's being run

7 sites across 2 states
New York4
New Jersey3

Study leadership

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

Who to contact

Urvi A Shah, MD, MS
[email protected]
646-608-3713
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Confirmed prior diagnosis MGUS or of smoldering myeloma (any time prior). However, confirmation of diagnosis must be documented in their last local oncologist clinic note 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 with the 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 Keenoa app
Be residing within the United States for the study duration.
English speaking or a family member or caregiver who speaks English and is able to assist with the surveys and phone based Keenoa app.

Exclusion

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 stop these for 2 weeks prior to enrollment on study.
Patients that already follow a whole foods plant based diet (ovo-lactovegetarian or processed junk food vegan diets are not excluded). This will be per research dietitian evaluation and discretion after nutrition screening.
Legume allergy
Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews
Concurrent participation in weight loss/dietary trials or defined programs (that require specified diets/supplements on the program). Patients on weight loss drugs are 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 ability of the patient to complete the study safely
Current self-reported heavy alcohol use and is defined as \>5 drinks per day or \>15 drinks per week
Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking or medical marijuana.
Has a condition requiring antibiotics within 14 days of study intervention administration.
Plan for travel during the study that would preclude adherence to prescribed diets
History of active inflammatory bowel disease or major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment or any history of total colectomy, or bariatric surgery (bariatric surgery which does not disrupt the gastrointestinal lumen, i.e. restrictive procedures such as banding, are permitted)

What this trial measures

  • Relative abundance of stool butyrate producers at 2 weeksat 2 weeks

    To evaluate the change in stool butyrate levels, which is defined as the average of -1 and 0 week samples. Patient stool will be assessed for butyrate levels in batches by gas chromatography mass spectrometry.