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

• ClinicalTrials.gov Identifier: NCT06055894
• Recruitment Status: Recruiting
• First Posted: September 28, 2023
• Last Update Posted: March 22, 2024
• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: HealthTree Foundation
• Information provided by (Responsible Party): Memorial Sloan Kettering Cancer Center

Study Description

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	Intervention/treatment	Phase
Multiple Myeloma, Smoldering	Dietary Supplement: Omega-3; Dietary Supplement: Curcumin; Dietary Supplement: Probiotic; Other: Whole food, plant-based diet (WFPBD)	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This is a randomized, non blinded, telehealth based, national pilot study with 100 patients (25 per arm). Randomization will be stratified based on BMI (normal/elevated) and Mayo risk SMM criteria.
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: September 20, 2023
• Estimated Primary Completion Date: September 2026
• Estimated Study Completion Date: September 2026

Arms and Interventions

Arm	Intervention/treatment
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.	Dietary Supplement: Omega-3; For 2 weeks, patients will receive omega 3 fatty acid supplements 1640 mg (2 capsules) twice daily
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.	Dietary Supplement: Curcumin; For 2 weeks, patients in the curcumin arm will receive Curcumin C3 complex 1000 mg with 5 mg BioPerine twice daily
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.	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
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.	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).

Outcome Measures

Primary Outcome Measures :

1. evaluate the change in Butyrate levels [ Time Frame: at 2 weeks ]
   To evaluate the change in stool butyrate levels, which is defined as the average of -1 and 0 week samples. Patient stool will be assessed for butyrate levels in batches by gas chromatography mass spectrometry.

Secondary Outcome Measures :

1. evaluate the change in Butyrate levels [ Time Frame: at 1 week ]
   To evaluate the change in stool butyrate levels which is defined as the average of -1 and 0 week samples. Patient stool will be assessed for butyrate levels in batches by gas chromatography mass spectrometry.
2. Adherence [ Time Frame: at 2 weeks ]
   To evaluate the dietary or supplement compliance at 2 weeks. ≥ 70% of meals or pills during the 2-week intervention period, by ASA dietary recalls at each visit and pill diaries.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Contacts

Contact: Urvi Shah, MD; 646-608-3713; shahu@mskcc.org

Contact: Alexander Lesokhin, MD; 646-608-3717

Locations

United States, New Jersey

Memorial Sloan Kettering Basking Ridge (All Protocol Activities); Recruiting

Basking Ridge, New Jersey, United States, 07920

Contact: Urvi Shah, MD 646-608-3713

Memorial Sloan Kettering Monmouth (All Protocol Activities); Recruiting

Middletown, New Jersey, United States, 07748

Contact: Urvi Shah, MD 646-608-3713

Memorial Sloan Kettering Bergen (All Protocol Activities); Recruiting

Montvale, New Jersey, United States, 07645

Contact: Urvi Shah, MD 646-608-3713

United States, New York

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities); Recruiting

Commack, New York, United States, 11725

Contact: Urvi Shah, MD 646-608-3713

Memorial Sloan Kettering Westchester (All Protocol Activities); Recruiting

Harrison, New York, United States, 10604

Contact: Urvi Shah, MD 646-608-3713

Memorial Sloan Kettering Cancer Center (All Protocol Activities); Recruiting

New York, New York, United States, 10065

Contact: Urvi Shah, MD 646-608-3713

Memorial Sloan Kettering Nassau (All Protocol Activities); Recruiting

Uniondale, New York, United States, 11553

Contact: Urvi Shah, MD 646-608-3713

Sponsors and Collaborators

Memorial Sloan Kettering Cancer Center

HealthTree Foundation

Investigators

• Principal Investigator: Urvi Shah, MD; Memorial Sloan Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan Kettering Cancer Center 

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT06055894
• Other Study ID Numbers: 23-116
• First Posted: September 28, 2023
• Last Update Posted: March 22, 2024
• Last Verified: March 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:

Plant-Based Diet; Dietary Supplements; 23-116

Additional relevant MeSH terms:

Multiple Myeloma; Neoplasms, Plasma Cell; Smoldering Multiple Myeloma; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Hypergammaglobulinemia; Curcumin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action