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)

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Nov 29, 2022

Keywords

ClinConnect Summary

This clinical trial is exploring how a plant-based diet affects certain substances in the stool, specifically butyrate levels, in people with conditions called Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM). Participants will be placed in one of three groups: one following a plant-based diet, one taking omega-3 fatty acid and curcumin supplements, and a third group receiving a placebo, which is a harmless substance that looks like the real supplements. The study will last for at least 12 weeks, and researchers want to see how these different approaches change butyrate levels.

To be eligible for the trial, participants must be at least 18 years old and have a confirmed diagnosis of MGUS or SMM. They should also be willing to learn how to cook plant-based recipes. However, people who already follow a strict plant-based diet, have severe allergies, or are pregnant cannot participate. Throughout the study, participants will learn about healthy cooking and be monitored by the research team to ensure their safety. This trial is a great opportunity for those interested in dietary changes and their potential effects on health.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Confirmed diagnosis of MGUS or SMM
• • If non light chain MGUS/SMM then M spike must be either ≥ 0.2 g/dL or BM PC ≥10% (both not required)
• • If light chain MGUS/SMM then involved must be ≥10 mg/dL or BM PC ≥10% (both not required)
• • If IgA MGUS/SMM then an IgA level \>350 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
• • If IgD MGUS/SMM then an IgD level \>50 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
• • Age ≥18 years
• • Willingness to comply with all study-related procedures
• • ECOG performance status of 0-3
• • Interested in learning to cook plant based recipes
• Exclusion Criteria:
• • Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)
• • Legume allergy
• • Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.
• • Concurrent participation in weight loss/dietary/exercise programs
• • Mental impairment leading to inability to cooperate
• • Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date
• • Concurrent pregnancy
• • Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll
• • ≥ Grade 2 electrolyte 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 or any contraindications
• • Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week)
• • Current self-reported illicit drug use (eg heroin, cocaine not marijuana)