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New treatment option for Smoldering Multiple Myeloma (SMM)
Official title A Prospective Multicenter Study of the Effects of Plant-based Diets on Gut Microbiome and Derived Metabolites in Patients Affected by Smoldering Multiple Myeloma
ClinicalTrials.gov ID: NCT07069751
What this study is testing
- What it's testing
- Our overarching hypothesis is that plant-based diets will induce beneficial modifications of the gut microbiota favoring short fatty acid (SCFA)-producing commensals and a more advantageous CD8/Th17 ratio in sMM patients, thus preventing evolution to MM. Goal of this national, prospective, multicenter study is to demonstrate that plant-based diets substantially modify the gut microbiome inducing increased production of SCFAs in patients affected by sMM.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Participant is willing and able to give informed consent for participation in the study.
- Confirmed diagnosis of sMM according to IMWG criteria
- Absence of features of symptomatic or active myeloma requiring treatment (myeloma-defining events).
- Aged ≥18 and \</= 75 years
- Participant is willing to comply with all study-related procedures.
You likely can't join if
- Non-Caucasian people. Racial disparities in all stages of the disease characterize MM, and Blacks have an increased MGUS and MM risk and higher...
- Patients that already follow a whole food plant-based diet (≥ 40g/die;ovo-lacto-vegetarian or processed junk food vegan diets are not excluded)...
- Legume allergy.
- Severe allergies such as anaphylactic shock to nuts (specifically cashews).
- Concurrent participation in weight loss/dietary/exercise programs because of potential conflicts between the concurrent diet and high-fiber diet.
- Enrollment onto any other therapeutic investigational study.
See the full eligibility criteria
- Participant is willing and able to give informed consent for participation in the study.
- Confirmed diagnosis of sMM according to IMWG criteria
- Absence of features of symptomatic or active myeloma requiring treatment (myeloma-defining events).
- Aged ≥18 and \</= 75 years
- Participant is willing to comply with all study-related procedures.
- ECOG performance status of 0-1.
- Non-Caucasian people. Racial disparities in all stages of the disease characterize MM, and Blacks have an increased MGUS and MM risk and higher mortality rate than Whites.
- Patients that already follow a whole food plant-based diet (≥ 40g/die;ovo-lacto-vegetarian or processed junk food vegan diets are not excluded). These patients likely should already have high SCFA levels in their gut.
- Legume allergy.
- Severe allergies such as anaphylactic shock to nuts (specifically cashews).
- Concurrent participation in weight loss/dietary/exercise programs because of potential conflicts between the concurrent diet and high-fiber diet.
- Enrollment onto any other therapeutic investigational study.
- Concurrent pregnancy.
- Ongoing treatment for HBV, HCV or HIV.
- 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 (e.g., heroin, cocaine not marijuana).
- people that did not accept to sign the informed consent.
- people reporting infectious diseases requiring antibiotic therapy in the previous three months, ongoing antibiotic therapy, or prophylaxis. Antibiotic therapy dramatically modifies the composition of the gut microbiota.
- people affected by autoimmune diseases except for thyroiditis, and patients affected by small and large intestine dysfunctions (i.e., inflammatory bowel disease).
- Gammopathy-associated conditions beyond sMM (e.g. amiloydosis, POEMS, LCDD, etc).
The study team makes the final eligibility decision.
Where it's taking place
- Milan, Milano, Italy
- Bari, Italy
- Milan, Italy
- Parma, Italy
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milan, Milano, Italy; Bari, Italy; Milan, Italy; Parma, Italy. 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.