MyelomaNCT07911540
A Randomized Controlled Trial of a Wearable Core Body Temperature Sensor Versus Standard Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Patients Undergoing CAR T-Cell Therapy in an Outpatient Setting
A study testing TempShield Continuous Temperature Monitoring in people with Myeloma, run by Wake Forest University Health Sciences at 2 sites in United States.
Trial summary
The purpose of this research study is to see if a wearable temperature monitoring patch can detect cytokine release syndrome earlier than traditional oral temperature monitoring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloma
- What is being tested?
- TempShield Continuous Temperature Monitoring
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2026to 2 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Patients:
- Ability to understand and willingness to sign an IRB-approved informed consent
- Age ≥ 18 years at the time of consent
- Scheduled to undergo CAR-T therapy in the outpatient setting at AHWFBCCC
- Ability to read and understand the English and/or Spanish language
- As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study
Show all 11Show fewer
- Access to a mobile device for the duration of the trial
- Provider/Staff:
- Provider/staff participants must meet all of the following inclusion criteria to participate in the study:
- Verbally agree to participate
- Hospital at Home outpatient provider/advanced practice provider/nurse of at least one patient participant enrolled on Arm A who completed 14 days of temperature monitoring
Who cannot join
- Patients:
- Planned prophylactic tocilizumab for mitigation of CRS as documented in the clinical trials pathway submission
- History of silicone allergy
- History of Medical Adhesive-Related Skin Injury (MARSI)
- Known skin condition that might preclude safe application of the patch, in the opinion of the enrolling investigator
- Provider/Staff:
- None
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Atrium Health Levine Cancer
Charlotte, North Carolina, 28204
Courtney Schepel, 980-442-2327, Courtney.Schepel@advocatehealth.org
Cindy Varga, MD
Atrium Health Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, 27103
John McKay, DO, John.Mckay@wfusm.edu
About this study
The purpose of this research study is to see if a wearable temperature monitoring patch can detect cytokine release syndrome earlier than traditional oral temperature monitoring.
Read the detailed description
This randomized pilot study is designed to evaluate the efficacy of a continuous temperature-monitoring wearable patch in patients receiving CAR-T therapy in the outpatient setting, comparing its performance to standard institutional monitoring protocols.
- Conditions
- Myeloma
- Being tested
- TempShield Continuous Temperature Monitoring, Standard of Care
- Keywords
- Cytokine release syndrome, CAR-T infusion, TempShield patch
- Medical subject headings
- Neoplasms, Plasma Cell, Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TempShield Continuous Temperature MonitoringOther
Patient participants will receive instruction from a research designee regarding use of the TempShield patch and smartphone application for continuous at-home temperature monitoring. Patient participants will complete onboarding of the application on their smartphone with assistance from the research designee, if necessary. Patient participants should place the patch immediately after completion of CAR-T infusion in the outpatient setting, with assistance from the research designee.
Standard of CareOther
Standard of care oral temperature monitoring
| Study group | Role | What they receive |
|---|---|---|
| Arm A: TempShield Continuous Temperature Monitoring plus SOC Temperature Monitoring | Other | Standard of care oral temperature monitoring plus TempShield continuous temperature monitoring patch Receives: Other: TempShield Continuous Temperature Monitoring |
| Arm B: SOC Temperature Monitoring | Other | Standard of care oral temperature monitoring Receives: Other: Standard of Care |
| Arm C: Provider/Staff | No intervention | Providers/staff are Hospital at Home personnel who support patients undergoing outpatient CAR-T therapy and who have monitored at least one participant enrolled on Arm A of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first recorded temperature elevation indicative of Cytokine Release Syndrome (CRS)
Time (in hours) from the initiation of CAR-T infusion to the first occurrence of a recorded body temperature elevation of ≥ 100.4°F (38.0°C) during the 14-day post-CAR-T observation period. Participants who do not experience this defined temperature elevation within the 14 days will be censored at the time of their last recorded temperature reading during this window. Reported by arm.
Measured: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Secondary outcomes (12)
Incidence of temperature elevation indicative of Cytokine Release Syndrome (CRS)
Number of participants who experience at least one recorded body temperature elevation of ≥ 100.4°F (38.0°C) during the 14-day post-CAR-T observation period. Reported by arm.
Measured: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Incidence of high-grade (grade 2 or higher) Cytokine Release Syndrome (CRS)
Number of participants who experience grade 2 or higher CRS during the 14-day post-CAR-T observation period. Reported by arm.
Measured: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Time to resolution of Cytokine Release Syndrome (CRS) from temper elevation indicative of CRS (temperature ≥ 100.4 °F)
Time (in hours) from the from onset of fever indicative of CRS (temperature ≥ 100.4 °F) during the 14-day post-CAR-T observation period to resolution (i.e., when the participant no longer meets the CRS diagnostic criteria). If a participant experiences multiple episodes of CRS during the 14-day post-CAR-T observation period, the duration can be calculated per episode and cumulatively. This will be calculated for participants experiencing CRS (temperature ≥ 100.4 °F) during the 14-day post-CAR-T observation period. Reported by arm.
Measured: From the temperature elevation (≥ 100.4 °F) to resolution during the 14 days after CAR-T infusion.
Time to intervention after fever detection (temperature ≥ 100.4 °F)
Time (in hours) from documented temperature elevation of ≥ 100.4° F to clinician intervention (e.g., supportive care, medication followed by observation, etc.). This will be calculated for participants experiencing CRS during the 14-day post-CAR-T observation period. Reported by arm.
Measured: From the temperature elevation (≥ 100.4 °F) to intervention during the 14 days after CAR-T infusion.
Incidence of admission to the Intensive Care Unit (ICU) due to temperature elevation indicative of CRS
Number of participants admitted to the ICU due to temperature elevation indicative of CRS during the 14-day post-CAR-T observation period. Reported by arm.
Measured: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Time to discharge after admission to the Intensive Care Unit (ICU)
Time (in hours) from ICU admission to ICU discharge. If a participant has multiple ICU admissions during the 14-day post-CAR-T observation period, the duration will be calculated cumulatively. Reported by arm.
Measured: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Length of hospital stay
Number of inpatient nights from hospital admission to hospital discharge due to temperature elevation indicative of CRS during the 14-day post-CAR-T observation period. If a participant has multiple hospital admissions due to CRS during the 14-day post-CAR-T observation period, the duration reported will be cumulative across all stays. This endpoint will be calculated for participants admitted to this hospital during the 14-day post-CAR-T observation period due to temperature elevation indicative of CRS. Reported by arm.
Measured: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Number of participants experiencing ICANS during the 14-day post-CAR-T observation period. Reported by arm.
Measured: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Largest change in body temperature from baseline recorded during the 14-day post-CAR-T observation period
The maximum numerical difference in body temperature recorded from baseline during the 14-day post-CAR-T observation period. Reported by arm.
Measured: From the initiation of CAR-T infusion up to Day 14 post-infusion.
The proportion of hours during the 14-day post CAR-T observation period when patch was worn
The proportion of hours during the 14-day post-CAR-T observation period in which at least one valid human body temperature reading (86 °F to 108 °F) was recorded by the wearable patch, defined as Total adherence = (Number of hours with at least one valid temperature reading)/(24*14 hours). This will be calculated for participants randomized to wear the remote temperature monitoring device.
Measured: From the initiation of CAR-T infusion up to Day 14 post-infusion.
The proportion of paired temperature readings from the temperature patch and an oral thermometer within one degree Fahrenheit in a five-minute window during the 14-day post-CAR-T observation period
The number 5-minute intervals in the 14-day post-CAR-T observation period (from the first patch reading indicating a temperature from 86 °F to 108 °F), when concordance between the temperature patch and an oral thermometer within one degree Fahrenheit was observed.
Measured: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Patient satisfaction with CAR-T temperature monitoring methods
Patient satisfaction as assessed by the study survey, evaluating satisfaction on a Likert scale where higher scores indicate a higher level of patient satisfaction with the assigned monitoring method (standard of care vs. wearable patch).
Measured: The Day 14 post-infusion (+28 days) study calendar visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study startDec 2026 (estimated)
- Primary completion1 Aug 2028 (estimated)
- Study completion2 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelomaStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
- Responsible party
- Sponsor
- Investigators
- Cindy Varga, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911540
- Sponsor's protocol ID
- IRB00158734
- Other IDs
- ONC-MM-2501
- Status last verified
- Oct 2026
- First submitted
- 26 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of a Wearable Core Body Temperature Sensor Versus Standard Temperature Monitoring for Early Detection of Cytokine Release Syndrome in Patients Undergoing CAR T-Cell Therapy in an Outpatient Setting
- ClinicalTrials.gov ID
- NCT07911540
- Acronym / sponsor ID
- IRB00158734
- Conditions
- Myeloma
- Keywords
- Cytokine release syndrome, CAR-T infusion, TempShield patch
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist Comprehensive Cancer Center
- Study start
- Dec 2026 (estimated)
- Primary completion
- 1 Aug 2028 (estimated)
- Study completion
- 2 Jan 2029 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to see if a wearable temperature monitoring patch can detect cytokine release syndrome earlier than traditional oral temperature monitoring.
Detailed description
This randomized pilot study is designed to evaluate the efficacy of a continuous temperature-monitoring wearable patch in patients receiving CAR-T therapy in the outpatient setting, comparing its performance to standard institutional monitoring protocols.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A: TempShield Continuous Temperature Monitoring plus SOC Temperature Monitoring | Other | Other: TempShield Continuous Temperature MonitoringStandard of care oral temperature monitoring plus TempShield continuous temperature monitoring patch |
| Arm B: SOC Temperature Monitoring | Other | Other: Standard of CareStandard of care oral temperature monitoring |
| Arm C: Provider/Staff | No intervention | –Providers/staff are Hospital at Home personnel who support patients undergoing outpatient CAR-T therapy and who have monitored at least one participant enrolled on Arm A of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Ability to understand and willingness to sign an IRB-approved informed consent
- Age ≥ 18 years at the time of consent
- Scheduled to undergo CAR-T therapy in the outpatient setting at AHWFBCCC
- Ability to read and understand the English and/or Spanish language
- As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study
Key exclusion criteria (7 listed)
- Planned prophylactic tocilizumab for mitigation of CRS as documented in the clinical trials pathway submission
- History of silicone allergy
- History of Medical Adhesive-Related Skin Injury (MARSI)
- Known skin condition that might preclude safe application of the patch, in the opinion of the enrolling investigator
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TempShield Continuous Temperature MonitoringPatient participants will receive instruction from a research designee regarding use of the TempShield patch and smartphone application for continuous at-home temperature monitoring. Patient participants will complete onboarding of the application on their smartphone with assistance from the research designee, if necessary. Patient participants should place the patch immediately after completion of CAR-T infusion in the outpatient setting, with assistance from the research designee. | Other | Arm A: TempShield Continuous Temperature Monitoring plus SOC Temperature Monitoring |
| Standard of CareStandard of care oral temperature monitoring | Other | Arm B: SOC Temperature Monitoring |
Primary outcome
Time to first recorded temperature elevation indicative of Cytokine Release Syndrome (CRS)
Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Time (in hours) from the initiation of CAR-T infusion to the first occurrence of a recorded body temperature elevation of ≥ 100.4°F (38.0°C) during the 14-day post-CAR-T observation period. Participants who do not experience this defined temperature elevation within the 14 days will be censored at the time of their last recorded temperature reading during this window. Reported by arm.
12 secondary outcomes
Incidence of temperature elevation indicative of Cytokine Release Syndrome (CRS)
Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Incidence of high-grade (grade 2 or higher) Cytokine Release Syndrome (CRS)
Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Time to resolution of Cytokine Release Syndrome (CRS) from temper elevation indicative of CRS (temperature ≥ 100.4 °F)
Time frame: From the temperature elevation (≥ 100.4 °F) to resolution during the 14 days after CAR-T infusion.
Time to intervention after fever detection (temperature ≥ 100.4 °F)
Time frame: From the temperature elevation (≥ 100.4 °F) to intervention during the 14 days after CAR-T infusion.
Incidence of admission to the Intensive Care Unit (ICU) due to temperature elevation indicative of CRS
Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Time to discharge after admission to the Intensive Care Unit (ICU)
Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Length of hospital stay
Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Largest change in body temperature from baseline recorded during the 14-day post-CAR-T observation period
Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.
The proportion of hours during the 14-day post CAR-T observation period when patch was worn
Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.
The proportion of paired temperature readings from the temperature patch and an oral thermometer within one degree Fahrenheit in a five-minute window during the 14-day post-CAR-T observation period
Time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.
Patient satisfaction with CAR-T temperature monitoring methods
Time frame: The Day 14 post-infusion (+28 days) study calendar visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cindy Varga, MD principal investigator
Wake Forest University Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TempShield Continuous Temperature Monitoring in people with Myeloma, run by Wake Forest University Health Sciences at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Courtney Schepel ((980) 442-2327, Courtney.Schepel@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first recorded temperature elevation indicative of Cytokine Release Syndrome (CRS) (time frame: From the initiation of CAR-T infusion up to Day 14 post-infusion.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.