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

What's the purpose of this trial?

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. The investigators will also assess the potential impact of hair loss versus the discomfort and inconvenience of the scalp cooling procedure.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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

Additional Trial Information

Phase 0

Enrollment: 30 patients (estimated)

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Trial Locations

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California

Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute

Los Angeles, CA

Open and Accepting
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