RECRUITING

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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Conditions

Multiple MyelomaMonoclonal Gammopathy of Undetermined SignificancePlant-Based DietSupplements22-175

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2022-11-29
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05640843

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Confirmed diagnosis of MGUS or SMM
  2. * If non light chain MGUS/SMM then M spike must be either ≥ 0.2 g/dL or BM PC ≥10% (both not required)
  3. * If light chain MGUS/SMM then involved must be ≥10 mg/dL or BM PC ≥10% (both not required)
  4. * If IgA MGUS/SMM then an IgA level \>350 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
  5. * If IgD MGUS/SMM then an IgD level \>50 mg/dL and an abnormal immunofixation is required (M spike criteria not required).
  6. * Age ≥18 years
  7. * Willingness to comply with all study-related procedures
  8. * ECOG performance status of 0-3
  9. * Interested in learning to cook plant based recipes
  1. * Patients that already follow a whole foods plant based diet (ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)
  2. * Legume allergy
  3. * Severe allergies such as anaphylactic shock to nuts (specifically cashews). Peanuts are not included in the meals.
  4. * Concurrent participation in weight loss/dietary/exercise programs
  5. * Mental impairment leading to inability to cooperate
  6. * Enrollment onto any other therapeutic investigational study concurrently and up to 180 days prior to study start date
  7. * Concurrent pregnancy
  8. * Positive HBV, HCV or HIV PCR test will need to be treated first and once undetectable viral load patients may enroll
  9. * ≥ Grade 2 electrolyte abnormalities as defined by CTCAEv5.0 (need to be resolved before enrolling on study)
  10. * 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
  11. * Heavy drinker (defined as \>2 drinks per day or \>14 drinks per week)
  12. * Current self-reported illicit drug use (eg heroin, cocaine not marijuana)

Contacts and Locations

Study Contact

Urvi A Shah, MD, MS
CONTACT
646-608-3713
shahu@mskcc.org
Alexander Lesokhin, MD
CONTACT
646-608-3717

Principal Investigator

Urvi A Shah, MD, MS
PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
United States
Memorial Sloan Kettering Suffolk- Commack (All Protocol Activities)
Commack, New York, 11725
United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
United States
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York, 11553
United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

  • Urvi A Shah, MD, MS, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-29
Study Completion Date2026-11

Study Record Updates

Study Start Date2022-11-29
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • Plant-Based Diet
  • Supplements
  • 22-175

Additional Relevant MeSH Terms

  • Multiple Myeloma
  • Monoclonal Gammopathy of Undetermined Significance