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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Myeloma

Intervention / Treatment
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* Device: Penguin Cold Cap


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Penguin Cold Cap<br>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. | Device: Penguin Cold Cap<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From the start of study treatment (Day -2) until Day 30. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At Day 0 and Day 90. |