Recruiting

Observational Study

Sponsor:

Mayo Clinic

Code:

NCT07850284

Conditions

AL Amyloidosis

Multiple Myeloma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief 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.

Conditions

AL Amyloidosis

Multiple Myeloma

Study ID

NCT07850284

Start date

Aug 25, 2026

Status verified date

Sep, 2026

Completion date

Aug 25, 2028

Anticipated

Primary completion date

Aug 25, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Not able to give informed consent

Study Design

Enrollment

150 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Engagement (Aim 1) - daily and weekly response rates [ Time Frame: Up to 3 months ]
  • Engagement (Aim 1) - uninterrupted participation [ Time Frame: Up to 3 months ]
  • Engagement (Aim 1) - complete symptom data [ Time Frame: Up to 3 months ]
  • Acceptability (Aim 1) - CSQ-8 [ Time Frame: Up to 3 months ]
  • System-generated alerts (Aim 2) [ Time Frame: Up to 3 months ]
  • Symptom and Quality of Life (QOL) trajectories (Aim 3) - PROMIS-29 [ Time Frame: Baseline to 3 months ]
  • Symptom and QOL trajectories (Aim 3) - SF-36 [ Time Frame: Baseline to 3 months ]
  • Change in Frailty status (Aim 4) - IMWG-FI [ Time Frame: Baseline to 3 months ]

Central Contacts and Locations

Central contacts

Clinical Trials Referral Office

855-776-0015mayocliniccancerstudies@mayo.edu

Sarah Aug

507-538-1307

Locations

Mayo Clinic in Rochester

Recruiting

Rochester, Minnesota, United States, 55905

Contacts

Sarah Aug

507-538-1301

Principal Investigator:

Nadine Abdallah, MD

More Information

Sponsor

Mayo Clinic

Last update posted

Sep 30, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-01. This information was provided to ClinicalTrials.gov by Mayo Clinic on 2026-09-30. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.