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)

Memorial Sloan Kettering Cancer Center (MSK)

Status: Enrolling

Conditions: Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance

Treatments: Dietary Supplement: Algae omega 3; Other: Placebo supplements; Other: Whole Foods Plant-based Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05640843

22-175

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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150 participants in 3 patient groups, including a placebo group

Daily Harvest weekly

Experimental group

Description:

For 12 weeks, on the Daily Harvest weekly arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based company Daily Harvest weekly.

Treatment:

Other: Whole Foods Plant-based Diet

Supplements

Experimental group

Description:

For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.

Treatment:

Dietary Supplement: Algae omega 3

Placebo

Placebo Comparator group

Description:

For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).

Treatment:

Other: Placebo supplements