Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
Conditions
Keywords
Plant-Based Diet, Supplements, 22-175
Brief summary
The researchers are doing this study to look at how butyrate levels change in participants' stool after they are on a- plant-based diet for at least 12 weeks. All participants will have monoclonal gammopathy of undetermined significance (MGUS) or smoldering multiple myeloma (SMM). We will compare how the plant-based diet, omega-3 fatty acid and curcumin supplements, and placebo (an inactive substance that looks like the study supplements) affect butyrate levels in participants' stool.
Interventions
The meals will have a low glycemic index and contain legumes, vegetables, whole grains, and plant-based fats that have undergone minimal processing. 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 education materials. Patients will also receive dietary education and counselling from a research dietitian every 4 weeks for the 12-week intervention period. They will have access to the team for questions and support as needed
DIETARY_SUPPLEMENTAlgae Omega 3 + Curcumin
For 52 weeks on the supplement arm, patients will be given algae omega 3 supplements and curcumin supplements (Sabinsa pharmaceuticals) twice daily
OTHERPlacebo supplements
For 25 weeks on the placebo arm, patients will be given placebo supplements twice daily (Veggie Doctor/M and M pharmaceuticals and Sabinsa pharmaceuticals).
Sponsors
Memorial Sloan Kettering Cancer Center
Paula and Rodger Riney Foundation
Plantable
M and M labs
VeggieDoctor
Sabinsa pharmaceuticals
Daily Harvest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This is a randomized, multi-center pilot study with 150 patients (50 per arm). Randomization will be stratified based on BMI and MGUS/SMM status. Randomization in the supplement and placebo arms will be blinded.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of MGUS or SMM * If non light chain MGUS/SMM then M spike must be either ≥ 0.2 g/dL or BM PC ≥10% (both not required) * If light chain MGUS/SMM then involved must be ≥10 mg/dL or BM PC ≥10% (both not required) * If IgA MGUS/SMM then an IgA level \>350 mg/dL and an abnormal immunofixation is required (M spike criteria not required). * If IgD MGUS/SMM then an IgD level \>50 mg/dL and an abnormal immunofixation is required (M spike criteria not required). * Age ≥18 years * Willingness to comply with all study-related procedures * ECOG performance status of 0-3 * Interested in learning to cook plant based recipes
Exclusion criteria
* Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded) * Legume allergy * Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals. * Concurrent participation in weight loss/dietary/exercise programs * Mental impairment leading to inability to cooperate * Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date * Concurrent pregnancy * Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll * ≥ 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 or any contraindications * Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week) * Current self-reported illicit drug use (eg heroin, cocaine not marijuana) * Plan for prolonged travel during the study that would preclude adherence to prescribed diets * History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment * If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool microbiome diversity at 12 weeks | 12 weeks | To evaluate the change in stool microbiome diversity on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline |
Countries
United States
Contacts
CONTACTUrvi A Shah, MD, MS
CONTACTAlexander Lesokhin, MD
PRINCIPAL_INVESTIGATORUrvi A Shah, MD, MS
Memorial Sloan Kettering Cancer Center
Outcome results
None listed