RECRUITING

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

Conditions

Multiple Myeloma, Smoldering Plant-Based Diet Dietary Supplements 23-116

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-09-20

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06055894

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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)

Inclusion Criteria

Exclusion 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.

* 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)

Contacts and Locations

Study Contact

Urvi A Shah, MD, MS

CONTACT

646-608-3713

shahu@mskcc.org

Alexander Lesokhin, MD

CONTACT

646-608-3717

Principal Investigator

Urvi A Shah, MD, MS

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-20

Study Completion Date2026-09

Study Record Updates

Study Start Date2023-09-20

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

Plant-Based Diet
Dietary Supplements
23-116

Additional Relevant MeSH Terms

Multiple Myeloma, Smoldering