NCT04920084Active, not recruiting
A Study of a Plant-Based Diet in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)
A Pilot Plant-Based Dietary Intervention in Overweight and Obese Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION) Study
Source: ClinicalTrials.gov · Last updated 21 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 4 Jun 2021
- Start date
- 3 Jun 2021
- Primary completion date
- 30 Aug 2023
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Obesity, Multiple myeloma
- NCT number
- NCT04920084
What you commit to
- Study type: Interventional
- Participants enrolled: 23
- From 3 Jun 2021 to the primary completion date, 30 Aug 2023
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in weight loss/dietary/exercise programs
- Concurrent pregnancy
Other illness
- Legume allergy
- Severe allergies, such as anaphylactic shock to peanuts
- Mental impairment leading to inability to cooperate
- 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
Other
- Patients that already follow a whole foods plant based or vegan diet (ovo-lactovegetarian diets are not excluded)
- Enrollment onto any other therapeutic investigational study
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Commack Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan Kettering Bergen Coordinator of this site? Confirm its status | Montvale | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering Nassau Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.