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New treatment option for Multiple Myeloma
Official title FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease
ClinicalTrials.gov ID: NCT07446777
What this study is testing
- What it's testing
- The purpose of this study is to find out whether a dietary approach that includes prolonged overnight fasting, guided by a Mediterranean-style eating pattern, is feasible for patients with myeloma precursor disease or newly diagnosed multiple myeloma.
- Which group you join is decided by chance.
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
- 18 years of age or older.
- Any sex/gender.
- Able to provide consent.
- Able to speak, read, and understand English or Spanish.
- Diagnosis of Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), or Multiple Myeloma (MM) per standard...
You likely can't join if
- Individuals younger than 18 years of age.
- Unable to provide consent.
- Unable to read or understand English or Spanish.
- Any contraindication for diet changes as determined by physician.
- History of a clinical eating disorder.
- History of dementia or major psychiatric disease.
See the full eligibility criteria
- 18 years of age or older.
- Any sex/gender.
- Able to provide consent.
- Able to speak, read, and understand English or Spanish.
- Diagnosis of Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), or Multiple Myeloma (MM) per standard criteria:
- Cohort 1 - Participants must have a confirmed diagnosis of MGUS and SMM.
- Cohort 2 - Participants must have a confirmed new diagnosis of MM and be initiating anti-myeloma therapy.
- Delivery of anti-myeloma therapies at one of the following institutions:
- Sylvester Comprehensive Cancer Center (SCCC) (including satellite/network sites).
- University of Miami Health System.
- Approval from treating oncologist, confirmed via email or in writing.
- Eastern Cooperative Oncology Group (ECOG) Performance Status grade of \<2 a. PI approval needed if ECOG ≥ 2.
- Having not consistently (not equal to or more than 50% of the time) engaged in structured fasting (i.e., not regularly fasting for ≥12hr/night) for the past 3 months.
- Not consuming a Mediterranean diet by not meeting 2 or more out of the following 3 Mediterranean eating pattern goals in the prior 3 months: ≥3 servings of vegetables per day, ≥ 3 servings of beans and legumes per week...
- Internet access on a smart phone, tablet, or computer.
- Willing to be assigned by chance to a prolonged overnight fasting and guided Mediterranean dietary intervention or waitlist-control group.
- Individuals younger than 18 years of age.
- Unable to provide consent.
- Unable to read or understand English or Spanish.
- Any contraindication for diet changes as determined by physician.
- History of a clinical eating disorder.
- History of dementia or major psychiatric disease.
- History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure.
- History of autoimmune disease and on treatment at time of screening.
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 Miami, Florida, United States. 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.