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)

Multiple Myeloma Clinical Trial

Official title:

A Randomized Placebo Controlled Study of a Plant-Based Dietary Versus Supplement Versus Placebo Intervention in Patients With Monoclonal Gammopathy of Undetermined Significance (MGUS) and Smoldering Multiple Myeloma (SMM) - The Nutrition Prevention (NUTRIVENTION3) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05640843
• Other study ID #: 22-175
• Status: Recruiting
• Phase: N/A
• Start date: November 29, 2022
• Est. completion date: November 2026

Study information

• Verified date: May 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Urvi Shah, MD
• Phone: 646-608-3713
• Email: shahu[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Monoclonal Gammopathy of Undetermined Significance
• Multiple Myeloma
• Neoplasms, Plasma Cell
• Paraproteinemias
• Smoldering Multiple Myeloma

Intervention

Other:
• Whole Foods Plant-based Diet
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 an online portal from Plantable which contains education materials and access to a health coach daily. 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 Supplement:
• Algae omega 3
Algae omega 3 given twice daily.

Other:
• Placebo supplements
Placebo supplements given twice daily.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (All Protocol Activities)	Uniondale	New York

Sponsors (6)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	M and M labs, Paula and Rodger Riney Foundation, Plantable, Sabinsa pharmaceuticals, VeggieDoctor

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in stool butyrate levels	change in stool butyrate levels on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline	12 weeks

External Links

•   Memorial Sloan Kettering Cancer Center