Multiple MyelomaNCT05961215

Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma

A study testing Penguin Cold Cap in people with Multiple Myeloma, run by Cedars-Sinai Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This pilot study of scalp cooling with Penguin cold caps will examine the effectiveness of scalp cooling to reduce the development of hair loss in 30 participants with multiple myeloma undergoing high-dose chemotherapy with melphalan and autologous peripheral blood stem cell transplant at Cedars-Sinai Medical Center. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Multiple Myeloma
What is being tested?: Penguin Cold Cap
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 10 Aug 2023to 3 Feb 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Age ≥18 years
ECOG performance status ≤2
Confirmed multiple myeloma diagnosis
Hair covering ≥75% of scalp on physical exam at screening visit
Planning to undergo SOC high-dose chemotherapy with melphalan (dose to be used = 140 - 200 mg/m2 (with rounding per CSMC guidelines)) followed by an autologous peripheral blood stem cell transplant.
Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.

Who cannot join

Prior or current use of any scalp cooling treatment
Hair covering < 75% of the scalp on physical exam at screening visit.
Medical History and Concurrent Diseases: Reynaud's disease, Cold sensitivity, Cold agglutinin disease, Cryoglobulinemia, Cryofibrinogenemia
Current spinal or neck injury that may interfere with the subject's participation for the full duration of the study, in the opinion of the treating investigator
Skin conditions such as psoriasis, eczema, malignancy, or other condition on the scalp that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
Current use of oxaliplatin
Current use of any other investigational agents
Contraindication to melphalan

Trial locations and contacts

1 site in 1 country.

United States1 site

Cedars-Sinai Medical Center
Los Angeles, California, 90048

Other trials in United States

About this study

Official title: IIT2023-03-Vescio-ColdCap: Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma

Conditions: Multiple Myeloma
Being tested: Penguin Cold Cap
Medical subject headings: Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Penguin Cold CapDevice
Penguin cold cap: administered 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1.

Study groups in NCT05961215
Study group	Role	What they receive
Penguin Cold Cap	Experimental	Patients will receive Penguin cold cap: 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1. Receives: Device: Penguin Cold Cap

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Development of Hair Loss
Change in development of hair loss will be defined as < 50% hair loss (according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5, Grade 0 or 1) in 75% of patients treated. In CTCAE (Common Terminology Criteria for Adverse Events) version 5.0, alopecia is graded based on the extent of hair loss, with two main grades: Grade 1 (hair loss less than 50%, not obvious from a distance) and Grade 2 (hair loss of 50% or more, readily apparent). Grade 1 alopecia may be manageable with different hairstyles, while Grade 2 typically requires a wig or other camouflage if desired. Additionally, Grade 2 alopecia is more likely to impact a patient's quality of life. Grade 0 indicates that there is no alopecia (no hair loss) reported
Measured: Screening (Day 0), Day 30

Secondary outcomes (1)

Patient Determined Decision of Scalp Cooling Benefit
Patient determined decision of scalp cooling benefit will be measured by Scalp Cooling Questionnaire, a homegrown scale ranging from no benefit to substantial benefit, with higher scores representing a better outcome.
Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Aug 20233 Feb 2025

First posted27 Jul 2023
Study start10 Aug 2023
Primary completion1 Nov 2024
Study completion3 Feb 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Multiple MyelomaStudies of the same condition, open and under way.
More trials run by Cedars-Sinai Medical CenterThe 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05961215
Sponsor's protocol ID: IIT2023-03-Vescio-ColdCap
Status last verified: Oct 2025
First submitted: 18 Jul 2023
Last updated: 27 Oct 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
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Active, not recruitingPhase 3
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Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
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Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
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All Multiple Myeloma trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: IIT2023-03-Vescio-ColdCap: Scalp Cooling to Prevent Hair Loss in Patients Undergoing Stem Cell Transplantation for Multiple Myeloma
ClinicalTrials.gov ID: NCT05961215
Acronym / sponsor ID: IIT2023-03-Vescio-ColdCap
Conditions: Multiple Myeloma
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Cedars-Sinai Medical CenterUniversity, hospital or other
Collaborators: Penguin Cold Caps
Study start: 10 Aug 2023 (actual)
Primary completion: 1 Nov 2024 (actual)
Study completion: 3 Feb 2025 (actual)
First posted: 27 Jul 2023 (actual)
Results: Posted 27 Oct 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Penguin Cold Cap	Experimental	Device: Penguin Cold CapPatients will receive Penguin cold cap: 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Age ≥18 years
ECOG performance status ≤2
Confirmed multiple myeloma diagnosis
Hair covering ≥75% of scalp on physical exam at screening visit
Planning to undergo SOC high-dose chemotherapy with melphalan (dose to be used = 140 - 200 mg/m2 (with rounding per CSMC guidelines)) followed by an autologous peripheral blood stem cell transplant.

Key exclusion criteria (8 listed)

Prior or current use of any scalp cooling treatment
Hair covering < 75% of the scalp on physical exam at screening visit.
Medical History and Concurrent Diseases: Reynaud's disease, Cold sensitivity, Cold agglutinin disease, Cryoglobulinemia, Cryofibrinogenemia
Current spinal or neck injury that may interfere with the subject's participation for the full duration of the study, in the opinion of the treating investigator
Skin conditions such as psoriasis, eczema, malignancy, or other condition on the scalp that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

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
Penguin Cold CapPenguin cold cap: administered 60 minutes prior to melphalan infusion and continue for 5 hours after melphalan infusion start time, for a total of 6 hours, on Days -2 and -1.	Device	Penguin Cold Cap

Primary outcome

Change in Development of Hair Loss
Time frame: Screening (Day 0), Day 30
Change in development of hair loss will be defined as < 50% hair loss (according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAEs) Version 5, Grade 0 or 1) in 75% of patients treated. In CTCAE (Common Terminology Criteria for Adverse Events) version 5.0, alopecia is graded based on the extent of hair loss, with two main grades: Grade 1 (hair loss less than 50%, not obvious from a distance) and Grade 2 (hair loss of 50% or more, readily apparent). Grade 1 alopecia may be manageable with different hairstyles, while Grade 2 typically requires a wig or other camouflage if desired. Additionally, Grade 2 alopecia is more likely to impact a patient's quality of life. Grade 0 indicates that there is no alopecia (no hair loss) reported

1 secondary outcome

Patient Determined Decision of Scalp Cooling Benefit
Time frame: Day 90

Results and safety

Results posted to the registry on 27 Oct 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Penguin Cold Cap	31	30

Primary outcome: Change in Development of Hair Loss

Time frame: Screening (Day 0), Day 30. Count of participants. Unit: Participants

Measure	Penguin Cold Cap n = 30
Screening: 0 Alopecia	30
Screening: 1 Level	0
Screening: 2 Level	0
Day 30: 1 Level	4
Day 30: 0 Alopecia	26
Day 30: 2 Level	0

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events will be tracked from Day -2 to Follow-up visits (90 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Penguin Cold Cap	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Multiple Myeloma

Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm

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. This study is not recruiting at the moment.

Robert Vescio, MD principal investigator

Cedars-Sinai Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Penguin Cold Cap in people with Multiple Myeloma, run by Cedars-Sinai Medical Center at 1 site 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 6 inclusion and 8 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: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Development of Hair Loss (time frame: Screening (Day 0), Day 30). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05961215.

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 27 Oct 2025.