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

NCT07446777 | Recruiting DMC

• 1 other identifier: 20250792
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

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

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

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

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

Study Arms (2)

Arm 1: Intervention Group

EXPERIMENTAL

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; Behavioral: Prolonged Overnight Fasting (POF); Behavioral: Mediterranean Diet; Behavioral: Supportive Materials

Arm 2: Waitlist Control Group

EXPERIMENTAL

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); Behavioral: Mediterranean Diet

Interventions

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.

Arm 1: Intervention Group

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.

Arm 1: Intervention Group; Arm 2: Waitlist Control Group

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.

Arm 1: Intervention Group; Arm 2: Waitlist Control Group

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.

Arm 1: Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma

Interventions

Diet, Mediterranean

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Hypergammaglobulinemia; Precancerous Conditions

Intervention Hierarchy (Ancestors)

Diet, Plant-Based; Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Tracy E Crane, PhD, RDN

  University of Miami

  PRINCIPAL INVESTIGATOR

• Carl O Landgren, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grey Freylersythe, BS

CONTACT

(305) 243-9832; g.freylersythe@med.miami.edu

Michelle Armogan, MHA

CONTACT

(305) 243-7479; mda182@med.miami.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Clinical

Model Details: Participants will be randomly assigned to either the intervention or waitlist control group using a 2:1 randomization ratio.

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: April 7, 2026
• Primary Completion (Estimated): April 30, 2029
• Study Completion (Estimated): April 30, 2029
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)