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Scalp Cooling for Multiple Myeloma

N/A

Waitlist Available

Led By Robert Vescio, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Hair covering ≥75% of scalp on physical exam at screening visit

Age ≥18 years

Must not have

Contraindication to melphalan

Medical History and Concurrent Diseases: Reynaud's disease, Cold sensitivity, Cold agglutinin disease, Cryoglobulinemia, Cryofibrinogenemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of study treatment (day -2) until day 30.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how scalp cooling can reduce hair loss in 30 people with multiple myeloma undergoing chemo. It'll also look at how the scalp cooling procedure affects comfort & convenience.

Who is the study for?

This trial is for adults over 18 with multiple myeloma who are about to receive high-dose chemotherapy and a stem cell transplant. They must have good performance status, sufficient hair coverage, and be able to follow the study's procedures. People with cold-related diseases, certain skin conditions, spinal or neck injuries, or those using specific medications cannot participate.

What is being tested?

The study tests if Penguin Cold Caps can prevent hair loss in patients undergoing treatment for multiple myeloma. It involves wearing these special caps during chemotherapy sessions at Cedars-Sinai Medical Center to see if they reduce hair loss without causing too much discomfort.

What are the potential side effects?

Potential side effects from scalp cooling may include headaches, neck and shoulder discomfort, chills, and a risk of the cap not fully preventing hair loss. The procedure might also feel uncomfortable due to the cold temperature.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My hair covers most of my head.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I am scheduled for high-dose chemotherapy followed by a stem cell transplant.

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I have been diagnosed with multiple myeloma.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot take melphalan due to health reasons.

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I do not have conditions related to cold sensitivity like Reynaud's disease.

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Less than 75% of my scalp is covered with hair.

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I am currently taking oxaliplatin.

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I have used scalp cooling treatments before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the start of study treatment (day -2) until day 30.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the start of study treatment (day -2) until day 30.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of study treatment (day -2) until day 30. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in development of hair loss

Secondary study objectives

Patient determined decision of scalp cooling benefit

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Penguin Cold CapExperimental Treatment1 Intervention

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.

0 / 10Eligibility criteria met