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

NCT04920084 | Active Not Recruiting Results

• 1 other identifier: 21-135
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 7

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.

Conditions

Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Keywords

Plant-Based Diet; Nutrition; 21-135

Outcome Measures

Primary Outcomes (2)

• Difference of Body Mass Index From Baseline to Week 12

  Weight loss is defined as the average decrease in BMI at 12 weeks

  12 weeks

• Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 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).

  12 weeks

Study Arms (1)

Plant-based meals

EXPERIMENTAL

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

Interventions

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.

Plant-based meals

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (7)

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Bergen

Montvale, New Jersey, 07645, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Nassau

Uniondale, New York, 11553, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Condition Hierarchy (Ancestors)

Hypergammaglobulinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Paraproteinemias; Immunoproliferative Disorders; Immune System Diseases; Precancerous Conditions; Neoplasms

Results Point of Contact

• Title: Dr. Urvi Shah, MD, MS
• Organization: Memorial Sloan Kettering Cancer Center

shahu@mskcc.org

646-608-3713

Study Officials

• Urvi A Shah, MD, MS

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single-arm, single-center pilot.

Study Record Dates

• First Submitted: June 4, 2021
• First Posted: June 9, 2021
• Study Start: June 3, 2021
• Primary Completion: August 30, 2023
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 9, 2025
• Results First Posted: February 18, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (7)