NCT05640843 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Monoclonal Gammopathy of Undetermined Significance |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2022-11-29 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2022-11-29 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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) * Plan for prolonged travel during the study that would preclude adherence to prescribed diets * History of major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment * If already taking curcumin or omega 3 supplements patients must be willing to stop it on the date of trial consent for study duration.
Contact & Investigator
Urvi A Shah, MD, MS
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT05640843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Monoclonal Gammopathy of Undetermined Significance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05640843 currently recruiting?
Yes, NCT05640843 is actively recruiting participants. Contact the research team at ShahNutrivention@mskcc.org for enrollment information.
Where is the NCT05640843 trial being conducted?
This trial is being conducted at Atlanta, United States, Basking Ridge, United States, Middletown, United States, Montvale, United States and 4 additional locations.
Who is sponsoring the NCT05640843 clinical trial?
NCT05640843 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Urvi A Shah, MD, MS at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 180 participants.