Exploring the effects of a plant-based diet and supplements on smoldering multiple myeloma

Microbial Changes in Response to a Plant Based Diet and/or Supplements in SMM/MGUS Patients: A National Multi-Arm Randomized Prospective Telehealth Study Via HealthTree

This study is testing whether a plant-based diet and certain supplements can change butyrate levels in the stool of people with smoldering multiple myeloma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Locations: 7 sites (Basking Ridge, New Jersey and 6 other locations)
• Trial ID: NCT06055894 on ClinicalTrials.gov

What this trial studies

This study investigates how a plant-based diet and specific dietary supplements, such as omega-3, curcumin, and probiotics, influence butyrate levels in the stool of participants diagnosed with smoldering multiple myeloma. Participants will adhere to these dietary changes for two weeks, and researchers will compare the effects of each intervention on butyrate levels. The study aims to enhance understanding of dietary impacts on this condition and potentially improve patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of smoldering multiple myeloma or monoclonal gammopathy of undetermined significance (MGUS).

Not a fit: Patients currently taking supplements outside of the specified ones or those with other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into dietary interventions that may help manage smoldering multiple myeloma.

How similar studies have performed: While dietary interventions in cancer care are being explored, this specific approach focusing on butyrate levels in smoldering multiple myeloma is relatively novel.

Eligibility criteria

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 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). 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)

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
• Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
• Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
• Memorial Sloan Kettering Nassau (All Protocol Activities) — Uniondale, New York, United States (Recruiting)

Study contacts

• Principal investigator: Urvi A Shah, MD, MS — Memorial Sloan Kettering Cancer Center
• Study coordinator: Urvi A Shah, MD, MS

Conditions Multiple Myeloma, Smoldering; Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Plant-Based Diet; Dietary Supplements; 23-116