The Ambient Light Multiple Myeloma Study
Systematic Light Exposure Effects on Circadian Rhythms Entrainment, Inflammation, Neutropenic Fever and Symptom Burden Among Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
1 other identifier
interventional
200
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable multiple-myeloma
Started Feb 2023
Typical duration for not_applicable multiple-myeloma
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2023
CompletedStudy Start
First participant enrolled
February 13, 2023
CompletedFirst Posted
Study publicly available on registry
February 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
June 3, 2025
May 1, 2025
4.4 years
February 10, 2023
May 28, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Changes in Urinary Melatonin
Participants will be given vials for collection and detailed instructions to void their bladders on AM rising and any prior nighttime voids starting 2 h prior to their normal bedtimes, at which time they will be asked to dim the lights down to a minimum and avoid using their self-luminous displays. Participants (and nurses) will collect each void during that overnight in a separate vial and to record the times of each voiding. Urinary melatonin-sulfate (6 sulfatoxymelatonin, aMT6s) measurements will be assayed using a commercially available ELISA kit (IBL International, Hamburg, Germany).
Baseline visit and 3 days after the Autologous Stem Cell Transplant
Secondary Outcomes (29)
Sleep Efficiency using Actigraphy at 7 days post-transplant
at 7 days post-transplant
Sleep Efficiency using Actigraphy at 3 days after engraftment
at 3 days after engraftment
Sleep Efficiency using Actigraphy at 4 weeks after engraftment
at 4 weeks after engraftment
Inflammatory cytokine CRP levels at Baseline
At baseline, or during the hospital visit prior to transplant
Inflammatory cytokine CRP levels at 7 days following transplant
at 7 days following transplant
- +24 more secondary outcomes
Study Arms (2)
Circadian Effective Lighting (CEL)
ACTIVE COMPARATORThe CEL will be performed in hospital sites over a 2-month period.
Circadian Ineffective Lighting (CIL)
SHAM COMPARATORThe comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting.
Interventions
Participants will receive lighting with a spectrum of 300K, 500 lux to the eye level between 7:00am and 10:00am in the morning, and hospital lighting (\<100lux) during the afternoon between 10:00am and 6:00pm. In the evening this group of participants will receive lighting with a spectrum of 3000K, \<50lux at eye light level between 6:00PM and bedtime.
Participants will receive lower lighting levels in the morning (lighting with A spectrum of 300k, \<50lux to the eye level between 7:00am and 10:00am) and the same lighting levels throughout the rest of the day.
Eligibility Criteria
You may qualify if:
- Multiple Myeloma diagnosis
- Scheduled to undergo their first Autologous Stem Cell Transplant procedure.
- years or older
- Able to provide informed consent.
- English-language proficient
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Icahn Schoool of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mariana Figueiro, PhD
Icahn School of Medicine at Mount Sinai
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Director of Light and Health Research Center at Mount Sinai
Study Record Dates
First Submitted
February 10, 2023
First Posted
February 21, 2023
Study Start
February 13, 2023
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Analyzed data from the study will be shared, as this information is more relevant to the research. IDP does not need to be shared for this research.