An interventional study of Penguin Cold Cap in Multiple Myeloma, sponsored by Cedars-Sinai Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-27.
Sponsored by Cedars-Sinai Medical Center · Not applicable, Interventional, and Supportive care
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.
3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.
This study's enrollment of 31 is below the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.
Browse Multiple Myeloma studies →Cedars-Sinai Medical Center is the lead sponsor of 441 studies on the registry; 108 are open to participants now.
Of its 62 completed or terminated interventional studies of FDA-regulated products, 47 (76%) have results posted.
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Exclusion Criteria:
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
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.
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
Time frame: Screening (Day 0), Day 30
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.
Time frame: Day 90
| Milestone | Penguin Cold Cap |
|---|---|
| Started | 31 |
| Completed | 30 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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
| Participants | Penguin Cold Cap |
|---|---|
| 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 |
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.
| Participants | Penguin Cold Cap |
|---|---|
| A big effect - 4 | 2 |
| Not at all | 8 |
| Somewhat had an effect - 3 | 6 |
| A little bit - 2 | 13 |
Collected over Adverse events will be tracked from Day -2 to Follow-up visits (90 days). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Penguin Cold Cap | 0/30 (0%) | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Penguin Cold Cap |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 14 |
| >=65 years | 16 |
| Age, Continuous(years) | Penguin Cold Cap |
|---|---|
| Mean | 64.43 ± 7.76 |
| Sex: Female, Male(Participants) | Penguin Cold Cap |
|---|---|
| Female | 17 |
| Male | 13 |
| Ethnicity (NIH/OMB)(Participants) | Penguin Cold Cap |
|---|---|
| Hispanic or Latino | 6 |
| Not Hispanic or Latino | 24 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Penguin Cold Cap |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 1 |
| Black or African American | 2 |
| White | 22 |
| More than one race | 3 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Penguin Cold Cap |
|---|---|
| United States | 30 |
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Cedars-Sinai Medical Center