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

Study Overview
=================
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.

Official Title
-----------------
A Pilot Plant-Based Dietary Intervention in Overweight and Obese Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION) Study

Conditions
-----------------
Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma

Intervention / Treatment
-----------------
* Other: Plant based meals


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm, single-center pilot.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plant-based meals<br>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. | Other: Plant based meals<br>* For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to an online portal from Plantable which contains education materials and access to a coach daily for 24 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss- body mass index (BMI) reduction | Weight loss is defined as the average decrease in BMI at 12 weeks | 12 weeks | 
| Patient adherence to the diet | Intervention defined as ≥70% of participants consuming a WFPBD for ≥70% of meals of the 12-week intervention period (determined via a dietary recall and nutritional survey). | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plant-Based Diet, Nutrition, 21-135