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Overnight Fasting and Mediterranean Diet for People With Multiple Myeloma or Early Forms

Tests whether a fasting and Mediterranean eating plan is workable for people with myeloma.

Plain-language title generated from the registry record
Registry title: FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease

Key facts

Where
Miami, United StatesSee the site

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with MGUS, smoldering multiple myeloma, or newly diagnosed multiple myeloma. It tests a prolonged overnight fasting and Mediterranean-style eating plan.

Age
18 years or older
Sex
All sexes can join
Disease stage
Cohort 1: confirmed MGUS or smoldering multiple myeloma. Cohort 2: newly diagnosed multiple myeloma, starting anti-myeloma therapy.
Earlier treatment
Cannot have regularly fasted overnight for 12 hours or more in the past 3 months. Cannot already follow a Mediterranean diet.

Main reasons for not taking part

  • Cannot give consent, or cannot read or understand English or Spanish
  • Any diet change that a physician says is not safe
  • History of an eating disorder
  • History of dementia or major psychiatric disease
  • Stroke, heart attack or congestive heart failure within the past year

Read by machine on 9 November 2026.

Where in United States

  • University of MiamiMiami, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Miami
Trial code
NCT07446777
Record updated
1 May 2026
Original description
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.Read full original descriptionShow less

Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease (the FAST-M Study)

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.

Inclusion: 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.

Exclusion: 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; 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.

ClinicalTrials.gov NCT07446777