An observational study in AL Amyloidosis and Multiple Myeloma, sponsored by Mayo Clinic. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Mayo Clinic · Observational
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.
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
Exclusion Criteria:
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.
Other: Non-Interventional Study
Non-interventional study
Also known as: Non-Interventional Observational Study, Noninterventional (Observational) Study
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to 3 months
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