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Cold caps may keep hair during myeloma transplant

NCT ID NCT05961215

Symptom relief Sponsor: Cedars-Sinai Medical Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether wearing a special cooling cap during chemotherapy can prevent hair loss in people with multiple myeloma getting a stem cell transplant. 31 participants used the Penguin cold caps. The goal was to see if at least 75% of people kept more than half their hair. The study also asked patients if the benefit was worth the hassle.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

31 people

The number who actually took part.

Started

Aug 2023

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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

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Conditions

The condition(s) this trial relates to.

plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple myeloma

Contacts and locations

Locations

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.