Multiple Myeloma Clinical Trial

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

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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Confirmed prior diagnosis of smoldering myeloma (anytime prior). However, confirmation of SMM 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 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 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)
Concurrent use of prescription weight loss (such as semaglutides and tirzepatides) and/or therapeutic myeloma drugs such as daratumumab, lenalidomide, etc.) within 12 weeks 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 ability of the patient to complete the study safely
Current self reported heavy alcohol use (defined as >2 drinks per day or >14 drinks per week)
Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking. Oral marijuana/THC excluded or must stop >2 weeks prior.)
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)

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

100

Study ID:

NCT06055894

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

See Locations Near You

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge New Jersey, 07920, United States More Info
Urvi Shah, MD
Contact
646-608-3713
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown New Jersey, 07748, United States More Info
Urvi Shah, MD
Contact
646-608-3713
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale New Jersey, 07645, United States More Info
Urvi Shah, MD
Contact
646-608-3713
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack New York, 11725, United States More Info
Urvi Shah, MD
Contact
646-608-3713
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison New York, 10604, United States More Info
Urvi Shah, MD
Contact
646-608-3713
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York New York, 10065, United States More Info
Urvi Shah, MD
Contact
646-608-3713
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale New York, 11553, United States More Info
Urvi Shah, MD
Contact
646-608-3713

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

100

Study ID:

NCT06055894

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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