Multiple Myeloma
Conditions
Brief 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. The investigators will also assess the potential impact of hair loss versus the discomfort and inconvenience of the scalp cooling procedure.
Interventions
DEVICEPenguin 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.
Sponsors
Penguin Cold Caps
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Development of Hair Loss | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Determined Decision of Scalp Cooling Benefit | Day 90 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Penguin Cold Cap 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.
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. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Penguin Cold Cap |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants |
| Age, Continuous | 64.43 years STANDARD_DEVIATION 7.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 22 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 17 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Penguin Cold Cap | Change in Development of Hair Loss | Screening | 0 Alopecia | 30 Participants |
| Penguin Cold Cap | Change in Development of Hair Loss | Screening | 1 Level | 0 Participants |
| Penguin Cold Cap | Change in Development of Hair Loss | Screening | 2 Level | 0 Participants |
| Penguin Cold Cap | Change in Development of Hair Loss | Day 30 | 1 Level | 4 Participants |
| Penguin Cold Cap | Change in Development of Hair Loss | Day 30 | 0 Alopecia | 26 Participants |
| Penguin Cold Cap | Change in Development of Hair Loss | Day 30 | 2 Level | 0 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Penguin Cold Cap | Patient Determined Decision of Scalp Cooling Benefit | A big effect - 4 | 2 Participants |
| Penguin Cold Cap | Patient Determined Decision of Scalp Cooling Benefit | Not at all | 8 Participants |
| Penguin Cold Cap | Patient Determined Decision of Scalp Cooling Benefit | Somewhat had an effect - 3 | 6 Participants |
| Penguin Cold Cap | Patient Determined Decision of Scalp Cooling Benefit | A little bit - 2 | 13 Participants |