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)
Recruiting
N/AInterventional Study
Monoclonal Gammopathy of Undetermined SignificanceSmoldering Multiple Myeloma
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At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
180 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for people diagnosed with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). Participants will follow a plant-based diet for at least 12 weeks to see how it affects certain levels in their stool.
Are You a Good Fit for This Trial?
Must not be takingCurcuminOmega-3
Rules you outHeavy drinkingIllicit drug use
You may be able to join if
I have been diagnosed with MGUS or SMM.
I am at least 18 years old.
I am willing to follow the study procedures.
I can maintain a performance status between 0-3.
I want to learn how to cook plant-based recipes.
You may not be able to join if
I already follow a whole foods plant-based diet.
I have an allergy to legumes.
I have severe nut allergies.
I am currently in other diet or exercise programs.
I have a mental impairment affecting my cooperation.
I am pregnant.
I drink more than 2 alcoholic drinks per day.
I currently use illegal drugs.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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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 substa…
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.
Trial Locations
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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…
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)
* 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.
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