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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Monoclonal Gammopathy of Undetermined Significance Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Neoplasms Paraproteinemias Precancerous Conditions Smoldering Multiple Myeloma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Memorial Sloan Kettering Basking Ridge, Basking Ridge, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Plant based meals

Other

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.

Primary outcomes

Difference of Body Mass Index From Baseline to Week 12

Time frame: 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

Time frame: 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).

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study 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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2026
First posted: Jun 9, 2021
Registry last updated: Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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