Multiple MyelomaFAST-MNCT07446777
FAST-M: Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease
A study testing Health Coaching, Prolonged Overnight Fasting (POF) and Mediterranean Diet in people with Multiple Myeloma and Monoclonal Gammopathy of Undetermined Significance, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
- What is being tested?
- Health Coaching, Prolonged Overnight Fasting (POF) and Mediterranean Diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2026to 30 Apr 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Miami
Miami, Florida, 33136
Grey Freylersythe, BS, 305-243-9832, g.freylersythe@med.miami.edu
Michelle D Armogan, MHA, (305) 243-7479, mda182@med.miami.edu
About this study
Official title: 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.
- Conditions
- Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
- Being tested
- Health Coaching, Prolonged Overnight Fasting (POF), Mediterranean Diet, Supportive Materials
- Medical subject headings
- Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
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)Behavioural
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 DietBehavioural
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 MaterialsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Prolonged Overnight Fasting (POF); Behavioral: Mediterranean Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: 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.
Measured: Up to 35 weeks (8 months)
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline, 24 weeks (6 months), up to 35 weeks (8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start7 Apr 2026
- Primary completion30 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either the intervention or waitlist control group using a 2:1 randomization ratio.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carl Ola Landgren, MD, PhD, University of Miami
- Investigators
- Tracy E Crane, PhD, RDN, Principal investigator, University of MiamiCarl O Landgren, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446777
- Sponsor's protocol ID
- 20250792
- Acronym
- FAST-M
- Status last verified
- Apr 2026
- First submitted
- 25 Feb 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Overnight Fasting and Mediterranean Dietary Intervention for Patients With Multiple Myeloma or Its Precursor Disease (the FAST-M Study)
- ClinicalTrials.gov ID
- NCT07446777
- Acronym / sponsor ID
- FAST-M / 20250792
- Conditions
- Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance, Smoldering Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 7 Apr 2026 (actual)
- Primary completion
- 30 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the intervention or waitlist control group using a 2:1 randomization ratio.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Intervention Group | Experimental | Behavioral: Health Coaching, Behavioral: Prolonged Overnight Fasting (POF), Behavioral: Mediterranean Diet, Behavioral: Supportive MaterialsParticipants 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. |
| Arm 2: Waitlist Control Group | Experimental | Behavioral: Prolonged Overnight Fasting (POF), Behavioral: Mediterranean DietParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 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:
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health CoachingParticipants 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. | Behavioural | Arm 1: Intervention Group |
| 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. | Behavioural | Arm 1: Intervention Group, Arm 2: Waitlist Control Group |
| Mediterranean DietParticipants 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. | Behavioural | Arm 1: Intervention Group, Arm 2: Waitlist Control Group |
| Supportive MaterialsParticipants 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. | Behavioural | Arm 1: Intervention Group |
Primary outcome
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.
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)
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.
2 secondary outcomes
Calculated changes in relative dose intensity (RDI) and reasons for change.
Time frame: Baseline, 24 weeks (6 months), up to 35 weeks (8 months)
Reason for changes in relative dose intensity (RDI).
Time frame: Baseline, 24 weeks (6 months), up to 35 weeks (8 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tracy E Crane, PhD, RDN principal investigator
University of Miami
Carl O Landgren, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching, Prolonged Overnight Fasting (POF) and Mediterranean Diet in people with Multiple Myeloma and Monoclonal Gammopathy of Undetermined Significance, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Grey Freylersythe, BS ((305) 243-9832, g.freylersythe@med.miami.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility: Percentage of Participants That Agree to Participate (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.