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Behavioural Intervention

Special Light Treatment for Multiple Myeloma

N/A

Recruiting

Led By Mariana Figueiro, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

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

Must have

Scheduled to undergo their first Autologous Stem Cell Transplant procedure

21 years or older

Must not have

Active infection including COVID-19 infection

Severe sleep disorders

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, or during the hospital visit prior to transplant

Summary

This trial will test how a special light treatment can help Multiple Myeloma patients with their sleep, inflammation and symptoms. 200 people will receive this light over a 2-month period.

Who is the study for?

This trial is for adults over 21 with multiple myeloma who are English-speaking and ready for their first autologous stem cell transplant. They must be able to consent to the study. Those pregnant, with eye diseases affecting light processing, other recent cancers, severe sleep or psychological disorders, history of bipolar/manic episodes, past light therapy use or active infections like COVID-19 cannot join.

What is being tested?

The study tests two lighting conditions on circadian rhythm in multiple myeloma patients during stem cell transplantation. It aims to see if 'Circadian Effective Lighting' versus 'Circadian Ineffective Lighting' can improve sleep efficiency, melatonin levels in urine, reduce inflammation and symptom burden over two months.

What are the potential side effects?

Since this trial involves lighting conditions rather than drugs or invasive procedures, side effects may include discomfort from the light settings or potential disruption of normal sleep patterns due to changes in exposure to certain types of artificial light.

Eligibility Criteria

Inclusion Criteria

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

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I am scheduled for my first stem cell transplant using my own cells.

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I am 21 years old or older.

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I am 21 years old or older.

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I have been diagnosed with Multiple Myeloma.

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I am scheduled for my first stem cell transplant using my own cells.

Exclusion Criteria

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

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I do not have an active infection, including COVID-19.

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I have a severe sleep disorder.

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I have been diagnosed with another cancer within the last 5 years.

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I have an eye condition that affects how I see light.

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I have used light therapy before.

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I have a history of bipolar disorder or manic episodes.

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I have had a stem cell transplant using my own cells.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 days following engraftment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 days following engraftment

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 days following engraftment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Changes in Urinary Melatonin

Secondary study objectives

Circadian Light levels measured with Daysimeter (light monitor) at 3 days after engraftment

Circadian Light levels measured with Daysimeter (light monitor) at 4 weeks after engraftment

Circadian Light levels measured with Daysimeter (light monitor) at 7 days post-transplant

+26 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Circadian Effective Lighting (CEL)Active Control1 Intervention

The CEL will be performed in hospital sites over a 2-month period.

Group II: Circadian Ineffective Lighting (CIL)Placebo Group1 Intervention

The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting.

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

902 Previous Clinical Trials

541,802 Total Patients Enrolled

10 Trials studying Multiple Myeloma

1,711 Patients Enrolled for Multiple Myeloma

Mariana Figueiro, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

10 Previous Clinical Trials

675 Total Patients Enrolled

Media Library

Circadian Effective Lighting (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05737732 — N/A

Multiple Myeloma Research Study Groups: Circadian Effective Lighting (CEL), Circadian Ineffective Lighting (CIL)

Multiple Myeloma Clinical Trial 2023: Circadian Effective Lighting Highlights & Side Effects. Trial Name: NCT05737732 — N/A

Circadian Effective Lighting (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05737732 — N/A

~123 spots leftby Jun 2027

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