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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)

Primary Purpose

Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Whole Foods Plant-based Diet
Algae omega 3
Placebo supplements
Sponsored by
Memorial Sloan Kettering Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Multiple Myeloma focused on measuring Plant-Based Diet, Supplements, 22-175

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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)

Sites / Locations

  • Memorial Sloan Kettering Basking Ridge (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Monmouth (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Bergen (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Westchester (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
  • Memorial Sloan Kettering Nassau (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Whole Foods Plant-based Diet

Supplements

Placebo

Arm Description

For 12 weeks, on the WFPBD arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based WFPBD company Plantable weekly.

For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.

For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 29, 2022
Last Updated
August 29, 2023
Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Paula and Rodger Riney Foundation, Plantable, M and M labs, VeggieDoctor, Sabinsa pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05640843
Brief 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)
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
November 2026 (Anticipated)
Study Completion Date
November 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
Paula and Rodger Riney Foundation, Plantable, M and M labs, VeggieDoctor, Sabinsa pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
Keywords
Plant-Based Diet, Supplements, 22-175

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Whole Foods Plant-based Diet
Arm Type
Experimental
Arm Description
For 12 weeks, on the WFPBD arm, patients will receive two premade meals per day, for lunch and dinner for 6 days weekly, prepared and shipped by U.S.-based WFPBD company Plantable weekly.
Arm Title
Supplements
Arm Type
Experimental
Arm Description
For 12 weeks on the supplement arm, patients will be given algae omega 3 supplements (QWell pharmaceuticals) and curcumin supplements (Sabinsa pharmaceuticals) twice daily.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
For 12 weeks on the placebo arm, patients will be given placebo supplements twice daily (QWell and Sabinsa pharmaceuticals).
Intervention Type
Other
Intervention Name(s)
Whole Foods Plant-based Diet
Intervention 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 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
Intervention Type
Dietary Supplement
Intervention Name(s)
Algae omega 3
Intervention Description
Algae omega 3 given twice daily.
Intervention Type
Other
Intervention Name(s)
Placebo supplements
Intervention Description
Placebo supplements given twice daily.
Primary Outcome Measure Information:
Title
Changes in stool butyrate levels
Description
change in stool butyrate levels on a dietary vs supplement vs placebo intervention at 12 weeks when compared to baseline
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Urvi Shah, MD
Phone
646-608-3713
Email
shahu@mskcc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Lesokhin, MD
Phone
646-608-3717
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Organizational Affiliation
Memorial Sloan Kettering Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Monmouth (All Protocol Activities)
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Bergen (All Protocol Activities)
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Westchester (All Protocol Activities)
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713
Facility Name
Memorial Sloan Kettering Nassau (All Protocol Activities)
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Urvi Shah, MD
Phone
646-608-3713

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org
Links:
URL
http://www.mskcc.org/mskcc/html/44.cfm
Description
Memorial Sloan Kettering Cancer Center

Learn more about this trial

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)

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