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

Verified

Overview

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.

SparkCures ID 1181
Trial Phase Pilot Trial
Enrollment 23 Patients
Trial Sponsors
  • Memorial Sloan Kettering Cancer Center
NCT Identifier

NCT04920084

CLOSED

This trial is active but is no longer accepting patients.

Am I Eligible?

The following criteria is a partial list of reasons why patients may or may not be eligible to participate in this clinical trial. Further evaluation with a medical professional will be required to determine full eligibility.

The following criteria is provided for health care professionals.

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

US Trial Locations

Please visit the ClinicalTrials.gov page for historical site information.

View Centers

Trial Links

Read the latest news and updates on this trial.

SparkCures Verified

SparkCures is working closely with Memorial Sloan Kettering Cancer Center to provide the most up-to-date information on this clinical trial. Use the button above to add this trial to your list of favorites.

Learn more about how we work with trial sponsors