Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
Conditions
Keywords
Plant-Based Diet, Nutrition, 21-135
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 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.
Interventions
OTHERPlant based meals
For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to an online portal from Plantable which contains education materials and access to a coach daily for 24 weeks.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a single-arm, single-center pilot.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference of Body Mass Index From Baseline to Week 12 | 12 weeks | Weight loss is defined as the average decrease in BMI at 12 weeks |
| Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks | 12 weeks | Intervention defined as ≥70% of participants consuming a whole food, plant-based diet/WFPBD for ≥70% of meals of the 12-week intervention period (determined via a dietary recall and nutritional survey). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Plant-based Meals 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.
Plant based meals: For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to an online portal from Plantable which contains education materials and access to a coach daily for 24 weeks. | 23 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Plant-based Meals |
|---|---|
| Age, Continuous | 62 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 14 Participants |
| Region of Enrollment United States | 23 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 23 |
| other Total, other adverse events | 15 / 23 |
| serious Total, serious adverse events | 14 / 23 |
Outcome results
Primary
Difference of Body Mass Index From Baseline to Week 12
Weight loss is defined as the average decrease in BMI at 12 weeks
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plant-based Meals | Difference of Body Mass Index From Baseline to Week 12 | BMI at 12 weeks | 32 kg/m^2 |
| Plant-based Meals | Difference of Body Mass Index From Baseline to Week 12 | BMI at baseline | 34.30 kg/m^2 |
Primary
Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks
Intervention defined as ≥70% of participants consuming a whole food, plant-based diet/WFPBD for ≥70% of meals of the 12-week intervention period (determined via a dietary recall and nutritional survey).
Time frame: 12 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Plant-based Meals | Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks | Adherence at baseline | 21 percentage of WFPBD meals consumed |
| Plant-based Meals | Percentage of Whole Food, Plant-based Diet/WFPBD Meals Consumed at Baseline and at 12 Weeks | Adherence at 12 weeks | 93 percentage of WFPBD meals consumed |