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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Smoldering Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance

Treatments: Other: Plant based meals

Study type: Interventional

Funder types: Other

Identifiers

NCT04920084

21-135

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Plant-based meals

Experimental group

Description:

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.

Treatment:

Other: Plant based meals