The Ambient Light Multiple Myeloma Study

Last updated: May 28, 2025
Sponsor: Icahn School of Medicine at Mount Sinai
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Myeloma

Platelet Disorders

Bone Neoplasm

Treatment

Circadian Ineffective Lightning (CIL)

Circadian Effective Lighting

Clinical Study ID

NCT05737732
STUDY-21-01146
  • Ages > 21
  • All Genders

Study Summary

The aim of this multi-site randomized control trial will be is to assess the impact Systematic lighting on circadian rhythm entrainment, Inflammation, Neutropenic Fever and Symptom Burden among Multiple Myeloma Patients undergoing Autologous Stem Cell Transplantation. To achieve this aim, 200 multiple myeloma patients will receive one of two different light-treatments that are designed to promote circadian rhythm alignment. While receiving these light treatments, participants' sleep efficiency, urine melatonin levels, blood inflammatory cytokine levels and symptoms will be assessed over a 2-month period.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Multiple Myeloma diagnosis

  • Scheduled to undergo their first Autologous Stem Cell Transplant procedure.

  • 21years or older

  • Able to provide informed consent.

  • English-language proficient

Exclusion

Exclusion Criteria:

  • Previous Autologous Stem Cell Transplant procedure

  • Pregnancy

  • Eye diseases which limit the ability of light to be processed

  • Secondary cancer diagnosis within the last 5 years

  • Severe sleep disorders

  • History of bipolar disorder or manic episodes

  • Severe psychological impairment

  • Previous use of light therapy

  • Active infection including COVID-19 infection

Study Design

Total Participants: 200
Treatment Group(s): 2
Primary Treatment: Circadian Ineffective Lightning (CIL)
Phase:
Study Start date:
February 13, 2023
Estimated Completion Date:
June 30, 2027

Study Description

Individuals undergoing Autologous Stem Cell Transplant (ASCT) experience major transplant-related complications including elevated symptom burden, high rates of neutropenic fever, and increases in inflammatory cytokines. These transplant-related complications are augmented by circadian rhythms disruption (CRD), which leads to misalignment between melatonin levels and sleep times. Since light is a strong synchronizer of circadian rhythms, the proposed multi-site randomized controlled trial (RCT) will investigate whether lighting designed to deliver circadian effective light that promotes circadian alignment, will: 1) promote higher nighttime melatonin levels and better nighttime sleep, 2) reduce pro-inflammatory cytokines, 3) lower rates of neutropenic fever and 4) improve symptom burden in cancer patients undergoing Autologous Stem Cell Transplant.

Hospital rooms for patients undergoing inpatient Autologous Stem Cell Transplant at the Mount Sinai Medical Center (MSMC) and at the Memorial Sloan Kettering Cancer Center (MSKCC)) will be retrofitted to install 1 of 2 lighting interventions, either circadian-effective (intervention) and circadian-ineffective (comparison) ambient light that may improve sleep.

1-2 weeks and no more than 2 months prior to transplant, participants will be given an Actiwatch, Daysimeter (personal light meter), sleep logs, questionnaires, and a urine collection kit to assess melatonin. One blood sample for cytokine analyses will be collected during one of the hospital visits prior to transplant. Blood draws are always done in the morning and always at a similar time for the same individual. The same outcomes (questionnaires, Actiwatch, Daysimeter, urine samples, blood samples) will be collected during transplant period and once, four weeks after engraftment.

Connect with a study center

  • Icahn Schoool of Medicine at Mount Sinai

    New York, New York 10029
    United States

    Active - Recruiting

  • Memorial Sloan Kettering Cancer Center

    New York, New York 10065
    United States

    Active - Recruiting

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