A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (… (NCT04920084) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)
United States23 participantsStarted 2021-06-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Difference of Body Mass Index From Baseline to Week 12
Timeframe: 12 weeks
2
Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks