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)
Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
About this trial
This is an interventional prevention trial for Multiple Myeloma focused on measuring Plant-Based Diet, Supplements, 22-175
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 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)
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Bergen (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
- Memorial Sloan Kettering Nassau (All Protocol Activities)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Whole Foods Plant-based Diet
Supplements
Placebo
For 12 weeks, on the WFPBD arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based WFPBD company Plantable weekly.
For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.
For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).