Multiple Myeloma Clinical Trial

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

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.

View Eligibility 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

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

23

Study ID:

NCT04920084

Recruitment Status:

Active, not recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 7 Locations for this study

See Locations Near You

Memorial Sloan Kettering Basking Ridge
Basking Ridge New Jersey, 07920, United States
Memorial Sloan Kettering Monmouth
Middletown New Jersey, 07748, United States
Memorial Sloan Kettering Bergen
Montvale New Jersey, 07645, United States
Memorial Sloan Kettering Commack
Commack New York, 11725, United States
Memorial Sloan Kettering Westchester
Harrison New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Memorial Sloan Kettering Nassau
Uniondale New York, 11553, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

23

Study ID:

NCT04920084

Recruitment Status:

Active, not recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

How clear is this clinincal trial information?

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