AL AmyloidosisNCT07850284
SMS-Based Remote Symptom Monitoring for Patients With Plasma Cell Disorders
An observational study of AL Amyloidosis and Multiple Myeloma, run by Mayo Clinic at 1 site in United States.
Trial summary
This study evaluates whether daily SMS-based (text messages) symptom monitoring is feasible and acceptable in patients who are undergoing treatment for multiple myeloma (MM) or systemic light chain amyloidosis (AL), and whether it can help in early identification of symptoms that may require clinical attention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AL Amyloidosis, Multiple Myeloma
- What is being tested?
- Non-Interventional Study
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2026to 25 Aug 2028
- Phase
- Observational
- 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
Study population: Patients age ≥ 18 years who have a diagnosis of MM and/or AL amyloidosis and are planned to start treatment at Mayo Clinic or another treatment facility
Who may be able to join
- Age >= 18 years
- Diagnosis of MM or AL based on IMWG diagnostic criteria
- Planned to start a new treatment within 14 days (+/-7 days)
- Able to provide written informed consent
Who cannot join
- Not able to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sarah Aug contact
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Sarah Aug, 507-538-1301
Nadine Abdallah, MD
About this study
This study evaluates whether daily SMS-based (text messages) symptom monitoring is feasible and acceptable in patients who are undergoing treatment for multiple myeloma (MM) or systemic light chain amyloidosis (AL), and whether it can help in early identification of symptoms that may require clinical attention.
- Conditions
- AL Amyloidosis, Multiple Myeloma
- Being tested
- Non-Interventional Study
- Medical subject headings
- Immunoglobulin Light-chain Amyloidosis, Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Also called Non-Interventional Observational Study, Noninterventional (Observational) Study
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients are enrolled in the Quality of life text message system and receive SMS text messages and complete questionnaires daily for 3 months on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Engagement (Aim 1) - daily and weekly response rates
Engagement will be evaluated by daily and weekly response rates. A response rate of ≥60% to daily prompts (e.g., ≥4 days per week) will be considered acceptable engagement.
Measured: Up to 3 months
Engagement (Aim 1) - uninterrupted participation
Engagement will be evaluated by the duration (number of days) of uninterrupted participation (e.g., consecutive response to daily prompts with missed days).
Measured: Up to 3 months
Engagement (Aim 1) - complete symptom data
Engagement will be evaluated by the proportion of days with complete symptom data entered by participants.
Measured: Up to 3 months
Acceptability (Aim 1) - CSQ-8
Acceptability will be measured using a post study survey: Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is a self-report questionnaire used to measure general client satisfaction. It consists of 8 questions answered on a 4-point scale (e.g., quite dissatisfied, mildly dissatisfied, mostly satisfied, very satisfied). Total scores range from 8 to 32 with higher scores indicating higher satisfaction.
Measured: Up to 3 months
System-generated alerts (Aim 2)
Will determine the proportion of alerts that prompt documented clinical actions (e.g., triage calls, provider outreach, medication adjustments, referrals, and/or unplanned visits). Alerts will be considered effective if ≥30% of alerts prompt clinical actions.
Measured: Up to 3 months
Symptom and Quality of Life (QOL) trajectories (Aim 3) - PROMIS-29
Daily symptom and quality of life (QOL) trajectories will be modeled across treatment cycles. The Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) is used to assess patient-reported outcomes over the past 7 days across seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, social roles participation, and pain interference. Scores are scaled so that an average person would have a score of 50. Higher scores indicate more of the item being measured. Raw scores are converted to T-scores, with higher scores indicating better quality of life (QOL). Changes in PROMIS-29 scores will be evaluated using established minimal clinically important differences (MCIDs). Clinically meaningful deterioration will be defined as ≥ 2-point worsening in symptom severity, emergence of new severe symptoms, and deterioration in QOL scores in ≥20% of patients.
Measured: Baseline to 3 months
Symptom and QOL trajectories (Aim 3) - SF-36
Daily symptom trajectories will be modeled across treatment cycles. The 36-Item Short Form Survey (SF-36) is used to measure patient health and disability. Participants rate items on a scale of 1 (all of the time) to 6 (none of the time) or 1 (not at all) to 5 (extremely) with higher scores indicating greater quality of life. Changes in SF-36 scores will be evaluated using established MCIDs. Clinically meaningful deterioration will be defined as ≥ 2-point worsening in symptom severity, emergence of new severe symptoms, and deterioration in QOL scores in ≥20% of patients.
Measured: Baseline to 3 months
Change in Frailty status (Aim 4) - IMWG-FI
Frailty will be assessed using the International Myeloma Working Group-Frailty Index (IMWG-FI). The IMWG-FI will be analyzed as a continuous and categorical variable; patients will be classified into 3 categories (fit, intermediate fit, or frail). Total scores range from 0-5, with a score of 0 indicating fit, a score of 1 indicating intermediate fitness, and a score of ≥2 indicating frailty.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2026
- Study start25 Aug 2026
- Primary completion25 Aug 2028 (estimated)
- Study completion25 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AL AmyloidosisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nadine H. Abdallah, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07850284
- Sponsor's protocol ID
- 26-002036
- Other IDs
- NCI-2026-06651
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 30 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SMS-Based Remote Symptom Monitoring for Patients With Plasma Cell Disorders
- ClinicalTrials.gov ID
- NCT07850284
- Acronym / sponsor ID
- 26-002036
- Conditions
- AL Amyloidosis, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 25 Aug 2026 (actual)
- Primary completion
- 25 Aug 2028 (estimated)
- Study completion
- 25 Aug 2028 (estimated)
- First posted
- 30 Sep 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.
This study evaluates whether daily SMS-based (text messages) symptom monitoring is feasible and acceptable in patients who are undergoing treatment for multiple myeloma (MM) or systemic light chain amyloidosis (AL), and whether it can help in early identification of symptoms that may require clinical attention.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients are enrolled in the Quality of life text message system and receive SMS text messages and complete questionnaires daily for 3 months on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients age ≥ 18 years who have a diagnosis of MM and/or AL amyloidosis and are planned to start treatment at Mayo Clinic or another treatment facility
Key inclusion criteria (4 listed)
- Age >= 18 years
- Diagnosis of MM or AL based on IMWG diagnostic criteria
- Planned to start a new treatment within 14 days (+/-7 days)
- Able to provide written informed consent
Key exclusion criteria (1 listed)
- Not able to give informed consent
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 |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational |
Primary outcome
Engagement (Aim 1) - daily and weekly response rates
Time frame: Up to 3 months
Engagement will be evaluated by daily and weekly response rates. A response rate of ≥60% to daily prompts (e.g., ≥4 days per week) will be considered acceptable engagement.
Engagement (Aim 1) - uninterrupted participation
Time frame: Up to 3 months
Engagement will be evaluated by the duration (number of days) of uninterrupted participation (e.g., consecutive response to daily prompts with missed days).
Engagement (Aim 1) - complete symptom data
Time frame: Up to 3 months
Engagement will be evaluated by the proportion of days with complete symptom data entered by participants.
Acceptability (Aim 1) - CSQ-8
Time frame: Up to 3 months
Acceptability will be measured using a post study survey: Client Satisfaction Questionnaire-8 (CSQ-8). The CSQ-8 is a self-report questionnaire used to measure general client satisfaction. It consists of 8 questions answered on a 4-point scale (e.g., quite dissatisfied, mildly dissatisfied, mostly satisfied, very satisfied). Total scores range from 8 to 32 with higher scores indicating higher satisfaction.
System-generated alerts (Aim 2)
Time frame: Up to 3 months
Will determine the proportion of alerts that prompt documented clinical actions (e.g., triage calls, provider outreach, medication adjustments, referrals, and/or unplanned visits). Alerts will be considered effective if ≥30% of alerts prompt clinical actions.
Symptom and Quality of Life (QOL) trajectories (Aim 3) - PROMIS-29
Time frame: Baseline to 3 months
Daily symptom and quality of life (QOL) trajectories will be modeled across treatment cycles. The Patient-Reported Outcomes Measurement Information System 29 (PROMIS-29) is used to assess patient-reported outcomes over the past 7 days across seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, social roles participation, and pain interference. Scores are scaled so that an average person would have a score of 50. Higher scores indicate more of the item being measured. Raw scores are converted to T-scores, with higher scores indicating better quality of life (QOL). Changes in PROMIS-29 scores will be evaluated using established minimal clinically important differences (MCIDs). Clinically meaningful deterioration will be defined as ≥ 2-point worsening in symptom severity, emergence of new severe symptoms, and deterioration in QOL scores in ≥20% of patients.
Symptom and QOL trajectories (Aim 3) - SF-36
Time frame: Baseline to 3 months
Daily symptom trajectories will be modeled across treatment cycles. The 36-Item Short Form Survey (SF-36) is used to measure patient health and disability. Participants rate items on a scale of 1 (all of the time) to 6 (none of the time) or 1 (not at all) to 5 (extremely) with higher scores indicating greater quality of life. Changes in SF-36 scores will be evaluated using established MCIDs. Clinically meaningful deterioration will be defined as ≥ 2-point worsening in symptom severity, emergence of new severe symptoms, and deterioration in QOL scores in ≥20% of patients.
Change in Frailty status (Aim 4) - IMWG-FI
Time frame: Baseline to 3 months
Frailty will be assessed using the International Myeloma Working Group-Frailty Index (IMWG-FI). The IMWG-FI will be analyzed as a continuous and categorical variable; patients will be classified into 3 categories (fit, intermediate fit, or frail). Total scores range from 0-5, with a score of 0 indicating fit, a score of 1 indicating intermediate fitness, and a score of ≥2 indicating frailty.
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 30 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Sarah Aug contact
Nadine H. Abdallah, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of AL Amyloidosis and Multiple Myeloma, run by Mayo Clinic 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 4 inclusion and 1 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 30 Sep 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 Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Engagement (Aim 1) - daily and weekly response rates (time frame: Up to 3 months). The study lists 8 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 30 Sep 2026.