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)

NARecruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

November 29, 2022

Primary Completion Date

November 30, 2026

Study Completion Date

November 30, 2026

Conditions
Monoclonal Gammopathy of Undetermined SignificanceSmoldering Multiple Myeloma
Interventions
OTHER

Whole Foods Plant-based Diet

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_SUPPLEMENT

Algae 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

OTHER

Placebo 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).

Trial Locations (8)

10065

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York

10604

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities), Harrison

11553

RECRUITING

Memorial Sloan Kettering Nassau (All Protocol Activities), Uniondale

11725

RECRUITING

Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities), Commack

30322

RECRUITING

Emory University (Data Collection Only), Atlanta

07920

RECRUITING

Memorial Sloan Kettering Basking Ridge (All Protocol Activities), Basking Ridge

07748

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities), Middletown

07645

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities), Montvale

All Listed Sponsors
collaborator

Paula and Rodger Riney Foundation

UNKNOWN

collaborator

Plantable

UNKNOWN

collaborator

M and M labs

UNKNOWN

collaborator

VeggieDoctor

UNKNOWN

collaborator

Sabinsa pharmaceuticals

UNKNOWN

collaborator

Daily Harvest

UNKNOWN

lead

Memorial Sloan Kettering Cancer Center

OTHER