Clinical trial NCT04920084: A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Keywords: Plant-Based Diet
Nutrition
21-135
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-06-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single-arm, single-center pilot.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Difference of Body Mass Index From Baseline to Week 12
timeFrame: 12 weeks
measure: Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Urvi A Shah, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: