Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05640843

A Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)

Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-04-16

180

Participants Needed

8

Research Sites

204 weeks

Total Duration

On this page

Sponsors

M

Memorial Sloan Kettering Cancer Center

Lead Sponsor

P

Paula and Rodger Riney Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

The researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. All participants will have monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). We will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.

CONDITIONS

Official Title

A Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed diagnosis of MGUS or SMM
  • For non light chain MGUS/SMM, M spike must be 20.2 g/dL or bone marrow plasma cells 210%
  • For light chain MGUS/SMM, involved light chain must be 210 mg/dL or bone marrow plasma cells 210%
  • For IgA MGUS/SMM, IgA level must be over 350 mg/dL and immunofixation abnormal
  • For IgD MGUS/SMM, IgD level must be over 50 mg/dL and immunofixation abnormal
  • Age 18 years or older
  • Willingness to follow all study procedures
  • ECOG performance status between 0 and 3
  • Interest in learning to cook plant-based recipes
Not Eligible

You will not qualify if you...

  • Already following a whole foods plant-based diet (ovo-lacto-vegetarian or processed junk food vegan diets allowed)
  • Allergy to legumes
  • Severe allergies such as anaphylactic shock to nuts (especially cashews; peanuts excluded from meals)
  • Participation in weight loss, dietary, or exercise programs
  • Mental impairment preventing cooperation
  • Participation in other therapeutic investigational studies currently or within 180 days prior
  • Pregnancy
  • Positive HBV, HCV, or HIV PCR test until treated and undetectable
  • Grade 2 or higher electrolyte abnormalities until resolved
  • Investigator concerns about safety or contraindications
  • Heavy alcohol use (more than 2 drinks per day or 14 per week)
  • Current illicit drug use (heroin, cocaine, not marijuana)
  • Plans for prolonged travel during study that affect diet adherence
  • Major gastrointestinal surgery within 3 months (excluding appendectomy or cholecystectomy)
  • Current use of curcumin or omega-3 supplements unless willing to stop on trial start

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 8 locations

1

Emory University (Data Collection Only)

Atlanta, Georgia, United States, 30322

Actively Recruiting

2

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

3

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States, 07748

Actively Recruiting

4

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States, 07645

Actively Recruiting

5

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)

Commack, New York, United States, 11725

Actively Recruiting

6

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States, 10604

Actively Recruiting

7

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States, 10065

Actively Recruiting

8

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States, 11553

Actively Recruiting

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Research Team

U

Urvi A Shah, MD, MS

CONTACT

A

Alexander Lesokhin, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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