SMS-Based Remote Symptom Monitoring for Patients With Plasma Cell Disorders

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

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

What is being measured

The primary outcome is the main question the study is designed to answer.

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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.

1. First posted30 Sep 2026
2. Study start25 Aug 2026
3. Primary completion25 Aug 2028 (estimated)
4. 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.