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NCT Number: NCT07446777

FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease

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.

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Key information

Conditions

Multiple Myeloma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Hypergammaglobulinemia Immune System Diseases Immunoproliferative Disorders Lymphoproliferative Disorders Monoclonal Gammopathy of Undetermined Significance Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Precancerous Conditions Smoldering Multiple Myeloma Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Carl O Landgren, MD

PRINCIPAL_INVESTIGATOR

Grey Freylersythe, BS

CONTACT

[email protected]

305-243-9832

Michelle D Armogan, MHA

CONTACT

[email protected]

(305) 243-7479

Tracy E Crane, PhD, RDN

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion 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, 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 criteria

  • 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.

Treatment and study plan

Health Coaching

Behavioral

Participants will receive weekly health coaching sessions via telephone, video call, or in-person. The health coach will contact the participant after randomization to begin the intervention, which will include education on POF and following a Mediterranean diet. Sessions are expected to last 30-45 minutes and may be divided per participant preference. Participant safety and well-being will be addressed at each session, and modifications to the diet or session schedule will be made as necessary and documented. The sessions will be centrally administered by trained nutrition counselors within the Crane Lab under the supervision of a registered dietitian specializing in oncology.

Prolonged Overnight Fasting (POF)

Behavioral

Participants will be instructed to not consume any calorie-containing food/drinks after 8pm and to wait 14 hours after the fasting start before resuming eating the next day. Participants will use the My Wellness Research (MWR) platform to record fasting start and stop times and times food intake daily. Additionally, workbook containing educational materials and guidance to support adherence to POF goals will be provided. In the first two weeks, participants will be encouraged to fast for at least 12 hours nightly, gradually increasing to 14 hours. Participants will aim to fast up to 14 hours overnight for six days per week, with the option of taking the seventh day off from fasting.

Mediterranean Diet

Behavioral

Participants will be encouraged to adopt key components of the Mediterranean diet, including consuming 4+ vegetable servings (2.5-3 cups) daily, 2+ fruit servings (1.5-2 cups) daily, 2+ whole grain servings daily, 1+ legume serving daily, 1+ serving nuts and seeds daily, and seafood 2 times per week.

Supportive Materials

Behavioral

Participants in the intervention arm will be provided with a workbook with information and support to encourage meeting the POF and Mediterranean diet goals. Additionally, participants will be requested to utilize the My Wellness Research (MWR) platform to track their dietary goals as well as a Fitbit. For participants who choose not to use the app, a paper diet tracking sheet will be provided, and participants will be advised to send a picture of their completed tracking sheet by text message to the research team each week. Participants will also receive supportive and informational short message service (SMS) text messages 3 times per week during the study; participants can opt-out of these messages.

Primary outcomes

  1. Feasibility: Percentage of Participants That Agree to Participate

    Time frame: Baseline

    Feasibility will be measured as the percentage of participants that consent and agree to participate. Criterion for success: At least (≥) 50% of all eligible participants consent to participate.

  2. Retention Rate Among Participants Assigned to the Intervention Arm

    Time frame: Up to 35 weeks (8 months)

    The retention rate will be reported as the percentage of participants assigned to the intervention arm who complete all intervention sessions. Criterion for success: At least (≥) 80% of all assigned participants complete intervention sessions across both cohorts:

    • Cohort 1: Participants with Myeloma Precursor Disease
    • Cohort 2: Participants with Newly Diagnosed Multiple Myeloma (NDMM)

  3. Satisfaction Rate Among Participants on Both Arms

    Time frame: Up to 35 weeks (8 months)

    The satisfaction rate among participants on both arms (intervention and waitlist control) will be measured via structured exit interviews and reported. Criterion for success: At least (≥) 80% of all participants report satisfaction with the assigned intervention components on both arms.

Secondary outcomes

  1. Calculated changes in relative dose intensity (RDI) and reasons for change.

    Time frame: Baseline, 24 weeks (6 months), up to 35 weeks (8 months)

    Change in anti-myeloma therapy relative dose intensity (RDI) at 24 weeks (6 months) and about 35 weeks (8 months) compared to baseline will be reported between both the intervention and waitlist control arms. RDI is an integrated measure of dose delays and reductions in anti-myeloma therapy. The investigators will calculate the effect sizes for RDI with Cohen's D (Mean difference divided by the pooled standard deviation) and hazard ratio, respectively. The investigators will also calculate those effect sizes for each anti-myeloma therapy.

  2. Reason for changes in relative dose intensity (RDI).

    Time frame: Baseline, 24 weeks (6 months), up to 35 weeks (8 months)

    The reasons for change in anti-myeloma therapy relative dose intensity (RDI) at 24 weeks (6 months) and about 35 weeks (8 months) compared to baseline will be reported between both the intervention and waitlist control arms. The investigators will run statistical test for the intervention effects on the repeatedly observed RDI at post-intervention and follow-up using the generalized linear mixed model (GLMM) incorporating correlation within-subject.

Study contacts

Contact information is provided by the study sponsor or research team.

Grey Freylersythe, BS

CONTACT

[email protected]

(305) 243-9832

Michelle Armogan, MHA

CONTACT

[email protected]

(305) 243-7479

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

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

Acronym: FAST-M

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Mar 3, 2026
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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