NCT07446777Recruiting
FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease
Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease (the FAST-M Study)
Source: ClinicalTrials.gov · Last updated 1 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 25 Feb 2026
- Start date
- Apr 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- University of Miami
- Diseases
- Multiple myeloma
- NCT number
- NCT07446777
What you commit to
- Study type: Interventional
- Planned participants: 120
- From Apr 2026 to the primary completion date, Apr 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Age
- Individuals younger than 18 years of age.
Other
- Unable to provide consent.
- Unable to read or understand English or Spanish.
- Any contraindication for diet changes as determined by physician.
Who the study is looking for
- 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
- 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, or ≥ 1 serving of nuts per day.
- Mediterranean diet will be screened with select components of a Mediterranean Diet Adherence Screener (MEDAS).
- Internet access on a smart phone, tablet, or computer.
- Willing to be randomized to a prolonged overnight fasting and guided Mediterranean dietary intervention or waitlist-control group.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Miami Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.