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Back|NCT05640843Recruiting
Official Title

A Randomized Placebo Controlled Study of a Plant-Based Dietary Versus Supplement Versus Placebo Intervention in Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION-3) Study

Sponsor
Memorial Sloan Kettering Cancer Center
Enrollment
150
Timeline
Nov 2022 → Nov 2026
About This Study

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.

Eligibility Criteria

Inclusion Criteria

  • 1Confirmed diagnosis of MGUS or SMM
  • 2If non light chain MGUS/SMM then M spike must be either ≥ 0.2 g/dL or BM PC ≥10% (both not required)
  • 3If light chain MGUS/SMM then involved must be ≥10 mg/dL or BM PC ≥10% (both not required)
  • 4If IgA MGUS/SMM then an IgA level \>350 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
  • 5If IgD MGUS/SMM then an IgD level \>50 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
  • 6Age ≥18 years
  • 7Willingness to comply with all study-related procedures
  • 8ECOG performance status of 0-3
  • 9Interested in learning to cook plant based recipes

Exclusion Criteria

  • 1Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)
  • 2Legume allergy
  • 3Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.
  • 4Concurrent participation in weight loss/dietary/exercise programs
  • 5Mental impairment leading to inability to cooperate
  • 6Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date
  • 7Concurrent pregnancy
  • 8Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll
  • 9≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)
  • 10If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely or any contraindications
  • 11Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week)
  • 12Current self-reported illicit drug use (eg heroin, cocaine not marijuana)
  • 13Plan for prolonged travel during the study that would preclude adherence to prescribed diets
  • 14History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment
  • 15If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.

Locations

8 sites participating in this study

Emory University (Data Collection Only)

Atlanta, Georgia 30322

Recruiting

Nisha Joseph, MD

404-778-0519

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey 07920

Recruiting

Urvi A Shah, MD, MS

646-608-3713

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey 07748

Recruiting

Urvi A Shah, MD, MS

646-608-3713
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →