Smoldering Multiple Myeloma Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
University of Miami
RECRUITING
Miami
Contact Information
Primary
Grey Freylersythe, BS
g.freylersythe@med.miami.edu
(305) 243-9832
Backup
Michelle Armogan, MHA
mda182@med.miami.edu
(305) 243-7479
Time Frame
Start Date: 2026-04-07
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 120
Treatments
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.
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.
Sponsors
Leads: University of Miami

This content was sourced from clinicaltrials.gov