A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)

Not Applicable

Active, not recruiting

Conditions: Smoldering Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance

Brief Summary: This study will test whether a plant-based diet is practical (feasible) for overweight people with monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). The researchers will decide how practical the diet is by looking at how much weight participants lose and how well they are able to stick to the diet. The researchers will also determine whether the diet is effective in preventing multiple myeloma in participants. In addition, they will look at how safe the plant-based diet is for participants, and see if the diet affects participants' quality of life.

Recruitment & Eligibility

Inclusion Criteria

BMI ≥25
Confirmed diagnosis of MGUS or SMM
M spike (immunoglobulin) ≥0.2 g/dL or abnormal free light chain ratio with increased level of the appropriate involved light chain
Secretory disease
Age ≥18 years
Willingness to comply with all study-related procedures
ECOG performance status of 0-3
Interest to learn to cook plant based recipes

Exclusion Criteria

Patients that already follow a whole foods plant based or vegan diet (ovo-lactovegetarian diets are not excluded)
Legume allergy
Severe allergies, such as anaphylactic shock to peanuts
Concurrent participation in weight loss/dietary/exercise programs
Mental impairment leading to inability to cooperate
Enrollment onto any other therapeutic investigational study
Concurrent pregnancy
Patients with a known diagnosis of diabetes mellitus will not be excluded but will need to be followed regularly with an endocrinologist/primary care physician during the trial period.
Positive HBV, HCV, HIV PCR testing
Non English speaking
≥ 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

Arm && Interventions

Group	Intervention	Description
Plant-based meals	Plant based meals	Patients who will be administered a whole-foods plant-based diet for 12 weeks with nutrition counselling for 24 weeks.Participants will be asked to complete a survey via MSK Engage and a notification will be sent via email notification.

Primary Outcome Measures

Name	Time	Method
Difference of Body Mass Index From Baseline to Week 12	12 weeks	Weight loss is defined as the average decrease in BMI at 12 weeks
Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks	12 weeks	Intervention defined as ≥70% of participants consuming a whole food, plant-based diet/WFPBD for ≥70% of meals of the 12-week intervention period (determined via a dietary recall and nutritional survey).

Secondary Outcome Measures

Name	Time	Method

Locations (7): Memorial Sloan Kettering Monmouth
🇺🇸
Middletown, New Jersey, United States
Memorial Sloan Kettering Basking Ridge
🇺🇸
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Bergen
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Montvale, New Jersey, United States
Memorial Sloan Kettering Nassau
🇺🇸
Uniondale, New York, United States
Memorial Sloan Kettering Westchester
🇺🇸
Harrison, New York, United States
Memorial Sloan Kettering Commack
🇺🇸
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
🇺🇸
New York, New York, United States