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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma
• Intervention / Treatment: Behavioral: Health Coaching; Behavioral: Prolonged Overnight Fasting (POF); Behavioral: Mediterranean Diet; Behavioral: Supportive Materials

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grey Freylersythe, BS; Phone Number: (305) 243-9832; Email: g.freylersythe@med.miami.edu
• Study Contact Backup: Name: Michelle Armogan, MHA; Phone Number: (305) 243-7479; Email: mda182@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Tracy E Crane, PhD, RDN
      • Contact: Grey Freylersythe, BS; Phone Number: 305-243-9832; Email: g.freylersythe@med.miami.edu
      • Principal Investigator: Carl O Landgren, MD
      • Contact: Michelle D Armogan, MHA; Phone Number: (305) 243-7479; Email: mda182@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: Intervention Group; Participants in this group will receive the FAST-M intervention, which consists of prolonged overnight fasting (POF) and a Mediterranean diet. The intervention will be supported by dietary workbooks, nutrition journals, and a Fitbit to aid in tracking and adherence. Total participation duration is about six (6) months (24 weeks) for participants with myeloma precursor disease; and about eight (8) months (35 weeks for participants with newly diagnosed multiple myeloma (NDMM). An additional +/- four (4) weeks for catch-up sessions may be added for missed sessions, if necessary.	Behavioral: Health Coaching; 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.; Behavioral: Prolonged Overnight Fasting (POF); 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.; Behavioral: Mediterranean Diet; 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.; Behavioral: Supportive Materials; 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.
Experimental: Arm 2: Waitlist Control Group; Participants in this group will not receive any health coaching or study materials until the end of the study four weeks post-intervention, when they will receive one health coaching session, which will describe potential benefits of prolonged overnight fighting (POF) as well as adopting key components of the Mediterranean diet. Total participation duration is about six (6) months.	Behavioral: Prolonged Overnight Fasting (POF); 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.; Behavioral: Mediterranean Diet; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility: Percentage of Participants That Agree to Participate	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.	Baseline
Retention Rate Among Participants Assigned to the Intervention Arm	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)	Up to 35 weeks (8 months)
Satisfaction Rate Among Participants on Both Arms	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.	Up to 35 weeks (8 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Calculated changes in relative dose intensity (RDI) and reasons for change.	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.	Baseline, 24 weeks (6 months), up to 35 weeks (8 months)
Reason for changes in relative dose intensity (RDI).	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.	Baseline, 24 weeks (6 months), up to 35 weeks (8 months)

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Tracy E Crane, PhD, RDN, University of Miami; Principal Investigator: Carl O Landgren, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: February 25, 2026
• First Submitted That Met QC Criteria: February 25, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Precancerous Conditions; Neoplasms, Plasma Cell; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Hypergammaglobulinemia; Hemic and Lymphatic Diseases; Smoldering Multiple Myeloma; Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Therapeutics; Diet, Food, and Nutrition; Physiological Phenomena; Nutritional Physiological Phenomena; Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Diet; Diet, Mediterranean
• Other Study ID Numbers: 20250792

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No