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Compares treatment options for Monoclonal Gammopathy of Undetermined Significance
Official 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)
ClinicalTrials.gov ID: NCT05640843
What this study is testing
- What it's testing
- 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).
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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).
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Atlanta, Georgia, United States
- Basking Ridge, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Uniondale, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Atlanta, Georgia, United States; Basking Ridge, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.