NCT07446777 FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease
| NCT ID | NCT07446777 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Miami |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-04-07 |
| Primary Completion | 2029-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2026-04-07 with a primary completion date of 2029-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. 18 years of age or older. 2. Any sex/gender. 3. Able to provide consent. 4. Able to speak, read, and understand English or Spanish. 5. Diagnosis of Monoclonal Gammopathy of Undetermined Significance (MGUS), Smoldering Multiple Myeloma (SMM), or Multiple Myeloma (MM) per standard criteria: 1. Cohort 1 - Participants must have a confirmed diagnosis of MGUS and SMM. 2. Cohort 2 - Participants must have a confirmed new diagnosis of MM and be initiating anti-myeloma therapy. 6. Delivery of anti-myeloma therapies at one of the following institutions: 1. Sylvester Comprehensive Cancer Center (SCCC) (including satellite/network sites). 2. University of Miami Health System. 7. Approval from treating oncologist, confirmed via email or in writing. 8. Eastern Cooperative Oncology Group (ECOG) Performance Status grade of \<2 a. PI approval needed if ECOG ≥ 2. 9. 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. 10. 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). 11. Internet access on a smart phone, tablet, or computer. 12. Willing to be randomized to a prolonged overnight fasting and guided Mediterranean dietary intervention or waitlist-control group. Exclusion Criteria: 1. Individuals younger than 18 years of age. 2. Unable to provide consent. 3. Unable to read or understand English or Spanish. 4. Any contraindication for diet changes as determined by physician. 5. History of a clinical eating disorder. 6. History of dementia or major psychiatric disease. 7. History of recent (≤1 yr) stroke, myocardial infarction or congestive heart failure. 8. History of autoimmune disease and on treatment at time of screening.
Contact & Investigator
Tracy E Crane, PhD, RDN
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT07446777 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07446777 currently recruiting?
Yes, NCT07446777 is actively recruiting participants. Contact the research team at g.freylersythe@med.miami.edu for enrollment information.
Where is the NCT07446777 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT07446777 clinical trial?
NCT07446777 is sponsored by University of Miami. The principal investigator is Tracy E Crane, PhD, RDN at University of Miami. The trial plans to enroll 120 participants.