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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06055894
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Memorial Sloan Kettering Cancer Center
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Urvi Shah, MD
Principal Investigator Affiliation Memorial Sloan Kettering Cancer Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma, Smoldering
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: Omega-3

For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily Qwell™ Omega 3 by The Veggie Doctor™. Each 820 mg omega 3 supplement capsule contains 700 mg Docosohexaenoic acid, 100 mg Docosapentaenoic acid, and 20 mg Eicosapentaenoic acid. No dietary changes will be made but data on dietary intake will be collected.

Experimental: Curcumin

For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily from Sabinsa pharmaceuticals. No dietary changes will be made but data on dietary intake will be collected.

Experimental: Probiotic

For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily from Vita Miracle pharmaceuticals. No dietary changes will be made but data on dietary intake will be collected.

Experimental: Whole food, plant-based diet (WFPBD)

For 2 weeks, on the WFPBD arm, patients will receive 14 items weekly, prepared and shipped by U.S. based company, Daily Harvest once a week. The meals will have range from 2 breakfast, 11 lunch/dinners, 1 snack (provided Week 1), and whole grains items (provided Week 2). The meals will contain legumes, fruits, vegetables, whole grains, and plant-based fats that have undergone minimal processing. Detailed recommendations for additional meals outside those given by Daily Harvet meeting the standard of a WFPBD will also be given to supplement their individual daily calorie needs through the guidance of the research dietitian. Patients will receive a varied menu created by Daily Harvest and the study team on a weekly basis.

Interventions

Dietary Supplement: - Omega-3

For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily

Dietary Supplement: - Curcumin

For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily

Dietary Supplement: - Probiotic

For 2 weeks, patients in the probiotic arm will receive Ultra-50 probiotics with 50 billion CFU per capsule (one capsule) twice daily

Other: - Whole food, plant-based diet (WFPBD)

Daily Harvest once a week. The meals will have range from 2 breakfast, 11 lunch/dinners, 1 snack (provided Week 1), and whole grains items (provided Week 2).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Basking Ridge, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

Site Contact

Urvi Shah, MD

shahu@mskcc.org

646-608-3713

Middletown, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

Site Contact

Urvi Shah, MD

shahu@mskcc.org

646-608-3713

Montvale, New Jersey

Status

Recruiting

Address

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

Site Contact

Urvi Shah, MD

shahu@mskcc.org

646-608-3713

Commack, New York

Status

Recruiting

Address

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725

Site Contact

Urvi Shah, MD

shahu@mskcc.org

646-608-3713

Harrison, New York

Status

Recruiting

Address

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

Site Contact

Urvi Shah, MD

shahu@mskcc.org

646-608-3713

New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Site Contact

Urvi Shah, MD

shahu@mskcc.org

646-608-3713

Uniondale, New York

Status

Recruiting

Address

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553

Site Contact

Urvi Shah, MD

shahu@mskcc.org

646-608-3713