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New treatment option for Multiple Myeloma, Smoldering
Official title A Study of a Plant-Based Diet and Dietary Supplements in People With Smoldering Multiple Myeloma (SMM) or Monoclonal Gammopathy of Undetermined Significance (MGUS)
ClinicalTrials.gov ID: NCT06055894
What this study is testing
- What it's testing
- The researchers are going this to look at how butyrate levels change in participants' stool after they are on a plant-based diet or dietary supplements (omega-3, curcumin or probiotics) for 2 weeks. All participants will have smoldering multiple myeloma (SMM) or monoclonal gammopathy of undetermined significance (MGUS).
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 prior diagnosis MGUS or of smoldering myeloma (any time prior). However, confirmation of diagnosis must be documented in their last local...
- Age ≥18 years
- Willingness to comply with all study-related procedures
- Physically able to complete requirements for the study or has someone to assist with the requirements (such as meal preparation, stool shipment and...
- Interested in learning to cook plant-based recipes
You likely can't join if
- Taking any supplements other than vitamin D, iron, vitamin B12, potassium, magnesium, calcium or those needed for a medical indication must be...
- Patients that already follow a whole foods plant based diet (ovo-lactovegetarian or processed junk food vegan diets are not excluded). This will be...
- Legume allergy
- Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews
- Concurrent participation in weight loss/dietary trials or defined programs (that require specified diets/supplements on the program). Patients on...
- Mental impairment leading to inability to cooperate
See the full eligibility criteria
- Confirmed prior diagnosis MGUS or of smoldering myeloma (any time prior). However, confirmation of diagnosis must be documented in their last local oncologist clinic note within 6 months prior to study enrollment.
- Age ≥18 years
- Willingness to comply with all study-related procedures
- Physically able to complete requirements for the study or has someone to assist with the requirements (such as meal preparation, stool shipment and survey completion)
- Interested in learning to cook plant-based recipes
- Access to smart mobile phone or device with camera and ability to download Keenoa app
- Be residing within the United States for the study duration.
- English speaking or a family member or caregiver who speaks English and is able to assist with the surveys and phone based Keenoa app.
- Taking any supplements other than vitamin D, iron, vitamin B12, potassium, magnesium, calcium or those needed for a medical indication must be reviewed by PI. If patient is on a supplement (including curcumin...
- Patients that already follow a whole foods plant based diet (ovo-lactovegetarian or processed junk food vegan diets are not excluded). This will be per research dietitian evaluation and discretion after nutrition...
- Legume allergy
- Severe allergies such as anaphylactic shock to peanuts and/or tree nuts, such as cashews
- Concurrent participation in weight loss/dietary trials or defined programs (that require specified diets/supplements on the program). Patients on weight loss drugs are eligible.
- Mental impairment leading to inability to cooperate
- Enrollment onto any other therapeutic investigational study
- Concurrent pregnancy
- Patients on full dose anticoagulation
- If in the opinion of the investigator there maybe any concerns regarding the ability of the patient to complete the study safely
- Current self-reported heavy alcohol use and is defined as \>5 drinks per day or \>15 drinks per week
- Current self-reported illicit drug use (except inhaled marijuana, vaping or cigarette smoking or medical marijuana.
- Has a condition requiring antibiotics within 14 days of study intervention administration.
- Plan for travel during the study that would preclude adherence to prescribed diets
- History of active inflammatory bowel disease or major gastrointestinal surgery (not including appendectomy or cholecystectomy) within 3 months of enrollment or any history of total colectomy, or bariatric surgery...
The study team makes the final eligibility decision.
Where it's taking place
- 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 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 and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.