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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)
Trial Status: active
This clinical trial compares stool microbiome diversity change in participants after they are on a whole food, plant-based diet (WFPBD). The large intestine contains a community of trillions of bacteria called the gut microbiome. The gut microbiome promotes health in various ways. Butyrate is a short chain fatty acid that is produced by some types of gut bacteria when they break down or digest fiber. Butyrate is known to work against both cancer and inflammation. Researchers have seen that a plant-based diet can increase butyrate levels. A plant-based diet includes foods that are mainly from plants (for example, fruits, vegetables, nuts, beans, and whole grains). Researchers have also seen that omega-3 fatty acid and curcumin supplements can increase butyrate levels. Consuming a WFPBD and/or taking omega-3 fatty acid and curcumin supplements may help prevent multiple myeloma (MM) in people with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM).
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 bone marrow plasma cell (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
Eastern Cooperative Oncology Group (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 hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) polymerase chain reaction (PCR) test will need to be treated first and once undetectable viral load patients may enroll
>= Grade 2 electrolyte abnormalities as defined by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (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)
Plan for prolonged travel during the study that would preclude adherence to prescribed diets
History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment
If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.
Additional locations may be listed on ClinicalTrials.gov for NCT05640843.
Locations matching your search criteria
United States
Georgia
Atlanta
Emory University Hospital/Winship Cancer Institute
I. To evaluate the change in stool microbiome diversity on a dietary versus (vs) supplement vs placebo intervention at 12 weeks when compared to baseline.
SECONDARY OBJECTIVES:
I. To evaluate the change in relative abundance of stool butyrate producers between 3 arms at 24 weeks when compared to baseline.
II. To assess alterations in the fecal microbiome secondary to a diet vs supplement vs placebo intervention at 12, 24 and 52 weeks compared to baseline.
III. To evaluate the dietary or supplement compliance at 12 weeks.
IV. To assess changes in weight at 12, 24, and 52 weeks compared to baseline dietary vs supplement vs placebo intervention.
V. To determine the effects of a dietary vs supplement vs placebo intervention, on quality-of-life measures at 12 and 24 weeks.
VI. To assess alterations in metabolic markers secondary to a dietary vs supplement vs placebo intervention at 12 and 24 weeks when compared to baseline.
VII. To assess alterations in myeloma markers secondary to a dietary vs supplement vs placebo intervention at 12, 24 and 52 weeks when compared to baseline.
VIII. To assess safety of a dietary versus supplement versus placebo intervention up to 24 weeks.
IX. To evaluate a change in dietary pattern from baseline to 1 year.
EXPLORATORY OBJECTIVES:
I. To assess alterations in the fecal short chain fatty acids secondary to a diet vs supplement vs placebo intervention at 12 and 24 weeks compared to baseline.
II. To assess changes in weight at 78 (1.5 years) and 104 weeks (2 years) compared to baseline.
III. To evaluate a change in dietary pattern from baseline to 1 year; baseline to 1.5 years, and baseline to 2 years.
IV. To assess alterations in immune and plasma cell epigenetic and transcriptomic markers secondary to a diet vs supplement vs placebo intervention at 12, 24 or 52 weeks compared to baseline.
V. To explore changes in immune cell subsets and exhaustion/activation markers secondary to a diet vs supplement vs placebo intervention at 12, 24 or 52 weeks compared to baseline.
VI. To assess changes in body composition (visceral, subcutaneous and bone marrow fat) as determined on positron emission tomography (PET) imaging and correlate with weight changes as well as markers of disease.
VII. To compare differences in results for primary, secondary and exploratory objectives based on racial background.
OUTLINE: Patients are randomized into 1 of 3 arms.
ARM I: Patients receive premade frozen plant based meals and meet with a research dietitian on study.
ARM II: Patients receive omega 3 fatty acid orally (PO) and curcumin PO and meet with a research dietitian on study. After 12 weeks, patients also receive premade frozen plant based meals on study.
ARM III: Patients receive placebo PO and meet with a research dietitian on study. After 12 weeks, patients also receive premade frozen plant based meals on study.
All patients undergo biospecimen collection, bone marrow aspirate or bone marrow biopsy, magnetic resonance imaging (MRI), position emission tomography (PET) scan, and computed tomography (CT) scan while on study.
After completion of study intervention, patients are followed up at weeks 78 and 104.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationMemorial Sloan Kettering Cancer Center
