NCT05956457 PRO and Wearable Data Insights From Individuals With R/R Multiple Myeloma
| NCT ID | NCT05956457 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pack Health |
| Condition | Multiple Myeloma |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-09-15 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-09-15 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study will evaluate the feasibility of a digital health coaching program for adults with relapsed or refractory multiple myeloma (R/R MM). One hundred adults with R/R MM will be enrolled at The University of Washington. Individuals who agree to take part in the study and sign an informed consent will be enrolled in a 3-month digital health coaching program. The program will provide weekly phone calls plus the delivery of learning materials to text or email. Questionnaires and data from a wrist-worn activity tracker will be collected. Outcomes include treatment and symptom experience, quality of life, financial burden, and how confident people feel to manage their health. Information about your condition and treatment will be collected, along with how often you use services like the emergency room, for care. This data will provide a better understanding of how a person experiences their R/R MM.
Eligibility Criteria
Inclusion Criteria: 1. Age 18 or older 2. Confirmed diagnosis of MM as determined by participants' primary physicians at the study site. Patients with concurrent AL amyloidosis will be eligible. 3. Initiation of at least the second line of MM-directed therapy for multiple myeloma at time of study enrollment. Participants must have been exposed to at least one proteasome inhibitor (PI) and/or one immunomodulatory drug (IMiD). Exclusion Criteria: 1. Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment) 2. Individuals who have previously participated in Pack Health digital health coaching 3. Physician-assessed lack of sufficient English proficiency 4. Lack of ownership of a personal smartphone or device allowing for access to text, email or mobile application 5. Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with participant's safety, provision of informed consent, or compliance with study procedures 6. Concurrent enrollment on a therapeutic study in R/R MM that precludes simultaneous enrollment onto our non-therapeutic study
Contact & Investigator
Rahul Banerjee, MD
PRINCIPAL INVESTIGATOR
University of Washington
Frequently Asked Questions
Who can join the NCT05956457 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Multiple Myeloma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05956457 currently recruiting?
Yes, NCT05956457 is actively recruiting participants. Contact the research team at dgxpharesearch@questdiagnostics.com for enrollment information.
Where is the NCT05956457 trial being conducted?
This trial is being conducted at Seattle, United States.
Who is sponsoring the NCT05956457 clinical trial?
NCT05956457 is sponsored by Pack Health. The principal investigator is Rahul Banerjee, MD at University of Washington. The trial plans to enroll 100 participants.