Status:
ACTIVE_NOT_RECRUITING
A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Monoclonal Gammopathy of Undetermined Significance
Smoldering Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2026
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT04920084
Start Date
June 3 2021
End Date
June 1 2026
Last Update
September 9 2025
Active Locations (7)
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1
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725