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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Urvi A Shah, MD, MS — Memorial Sloan Kettering Cancer Center
• Study coordinator: Urvi A Shah, MD, MS
• Email: ShahNutrivention@mskcc.org
• Phone: 646-608-3713

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Prolonged overnight fasting combined with a Mediterranean-style diet for people with multiple myeloma or precursor conditions

  This program will test whether longer overnight fasting paired with a Mediterranean-style eating plan is doable for adults with MGUS, smoldering myeloma, or newly diagnosed multiple myeloma who are starting treatment.

  Recruiting University of Miami · Miami, Florida · NCT07446777

• Using Whole Body MRI to Improve Cancer Detection

  This study is testing if Whole Body MRI can help find bone and soft tissue problems in people with different types of cancer, like lymphoma and advanced prostate and breast cancer.

  Recruiting at 2 sites Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS · Bologna, BO and 2 other locations · NCT06895291

• Screening for M-protein in relatives of multiple myeloma patients in China

  This study is trying to see if screening for a specific protein in the blood can help find early signs of a blood condition in family members of people with multiple myeloma in China.

  Recruiting Shanghai Zhongshan Hospital · Shanghai, Shanghai Municipality · NCT05965115

• Understanding different types of multiple myeloma precursor conditions

  This study is trying to tell the difference between two early stages of multiple myeloma, smoldering multiple myeloma and monoclonal gammopathy of undetermined significance, to better understand how they progress or stay stable.

  Recruiting University of Miami · Miami, Florida · NCT05361694

• Investigating sleep apnea in patients with certain blood disorders

  This study is trying to see if sleep apnea affects the progression of blood disorders like MGUS and multiple myeloma in patients.

  Recruiting University of Iowa · Iowa City, Iowa · NCT04114084

• Registry and sample resource for patients with plasma cell disorders

  This study is gathering information from patients with plasma cell disorders like multiple myeloma to see how to improve their treatment and quality of life.

  Recruiting Ohio State University Comprehensive Cancer Center · Columbus, Ohio · NCT01408225

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.