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Device physiological monitoring for Multiple Myeloma

N/A
Recruiting
Led By Surbhi Sidana
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial aims to monitor the effects of CAR-T cancer cell therapy and improve the management of side effects. The study will use wearable sensors to track patients' physiological changes, analyze their molecular profiles, and

Who is the study for?
This trial is for adults over 18 with Multiple Myeloma, Lymphoma, or Leukemia who are undergoing CAR-T cell therapy at Stanford University. Participants must speak English and be able to use wearable devices and collect blood samples with the help of a caregiver.Check my eligibility
What is being tested?
The study tests if a Biostrap arm band can accurately monitor changes in patients' bodies during CAR-T therapy to manage side effects better. It also involves analyzing biological data (multiomic profile) alongside sensor and clinical data.See study design
What are the potential side effects?
While not testing drugs directly, this trial monitors for adverse events like Cytokine Release Syndrome and neurotoxicity that may occur from the underlying CAR-T cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Monitoring heart rate data
Monitoring temperature data
Secondary outcome measures
Microsampling
Safety of the microsampling device
Safety of wearable devices

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Device physiological monitoringExperimental Treatment1 Intervention
Patients will receive wearable sensor devices (Biostrap arm band)
Group II: MicrosamplingActive Control1 Intervention
Blood microsamples will be collected at start of conditioning chemotherapy, daily while in the hospital, and after leaving the hospital and outpatient appointments.
Group III: Biostrap mobile AppActive Control1 Intervention
Data collection from wearable sensor.

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Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,605 Total Patients Enrolled
9 Trials studying Multiple Myeloma
1,296 Patients Enrolled for Multiple Myeloma
Surbhi SidanaPrincipal InvestigatorStanford University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events
2021. "Wearable Sensors and Molecular Omics to Detect and Mitigate Cell Therapy Adverse Events". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05123001.
All > Leukemia
~1 spots leftby Jul 2024
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