Trial Title:
A Study Comparing a Plant-Based Diet With Supplements and Placebo in People With Monoclonal Gammopathy of Undetermined Significance (MGUS) or Smoldering Multiple Myeloma (SMM)
NCT ID:
NCT05640843
Condition:
Multiple Myeloma
Monoclonal Gammopathy of Undetermined Significance
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Smoldering Multiple Myeloma
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Conditions: Keywords:
Plant-Based Diet
Supplements
22-175
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
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.
Primary purpose:
Prevention
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Other
Intervention name:
Whole Foods Plant-based Diet
Description:
The meals will have a low glycemic index and contain 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
Arm group label:
Daily Harvest weekly
Intervention type:
Dietary Supplement
Intervention name:
Algae omega 3
Description:
Algae omega 3 given twice daily.
Arm group label:
Supplements
Intervention type:
Other
Intervention name:
Placebo supplements
Description:
Placebo supplements given twice daily.
Arm group label:
Placebo
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.
Criteria for eligibility:
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Urvi A Shah, MD, MS
Phone:
646-608-3713
Facility:
Name:
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Urvi A Shah, MD, MS
Phone:
646-608-3713
Facility:
Name:
Memorial Sloan Kettering Bergen (All Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Urvi A Shah, MD, MS
Phone:
646-608-3713
Facility:
Name:
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Urvi A Shah, MD, MS
Phone:
646-608-3713
Facility:
Name:
Memorial Sloan Kettering Westchester (All Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Urvi A Shah, MD, MS
Phone:
646-608-3713
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Urvi A Shah, MD, MS
Phone:
646-608-3713
Facility:
Name:
Memorial Sloan Kettering Nassau (All Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Urvi A Shah, MD, MS
Phone:
646-608-3713
Start date:
November 29, 2022
Completion date:
November 2026
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Paula and Rodger Riney Foundation
Agency class:
Other
Collaborator:
Agency:
Plantable
Agency class:
Other
Collaborator:
Agency:
M and M labs
Agency class:
Other
Collaborator:
Agency:
VeggieDoctor
Agency class:
Other
Collaborator:
Agency:
Sabinsa pharmaceuticals
Agency class:
Other
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05640843
http://www.mskcc.org/mskcc/html/44.cfm
