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NCT06055894 | RECRUITING | Multiple Myeloma, Smoldering

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

Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease

Multiple Myeloma, Smoldering

Intervention/treatment

Omega-3

Curcumin

Probiotic

Whole food, plant-based diet (WFPBD)

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : 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
Actual Study Start Date : 2023-09-20
Estimated Primary Completion Date : 2026-09
Estimated Study Completion Date : 2026-09

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Confirmed prior diagnosis MGUS or of smoldering myeloma (anytime 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)
  • * 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)
A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM)

Location Details

NCT06055894

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States, 07748

RECRUITING

United States, New Jersey

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States, 07645

RECRUITING

United States, New York

Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)

Commack, New York, United States, 11725

RECRUITING

United States, New York

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States, 10604

RECRUITING

United States, New York

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

RECRUITING

United States, New York

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States, 11553