The Ambient Light Multiple Myeloma Study

Trial Title: The Ambient Light Multiple Myeloma Study

NCT ID: NCT05737732

Condition: Multiple Myeloma

Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Device
Intervention name: Circadian Effective Lighting
Description: 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.
Arm group label: Circadian Effective Lighting (CEL)

Intervention type: Device
Intervention name: Circadian Ineffective Lightning (CIL)
Description: 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.
Arm group label: Circadian Ineffective Lighting (CIL)

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.

Detailed 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.

Criteria for eligibility:
Criteria:
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 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

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Icahn Schoool of Medicine at Mount Sinai

Address:
City: New York
Zip: 10029
Country: United States

Status: Recruiting

Contact:
Last name: Mariana Figueiro, PhD

Phone: 518-366-9306
Email: mariana.figueiro@mountsinai.org

Contact backup:
Last name: Barbara Plitnick, BSN

Phone: 518-242-4603
Email: Barbara.Plitnick@mountsinai.org

Investigator:
Last name: Mariana Figueiro
Email: Principal Investigator

Facility:
Name: Memorial Sloan Kettering Cancer Center

Address:
City: New York
Zip: 10065
Country: United States

Status: Not yet recruiting

Contact:
Last name: Sergio Giralt, MD
Email: giralts@mskcc.org

Investigator:
Last name: Sergio Giralt
Email: Principal Investigator

Start date: February 13, 2023

Completion date: June 30, 2027

Lead sponsor:
Agency: Icahn School of Medicine at Mount Sinai
Agency class: Other

Source: Icahn School of Medicine at Mount Sinai

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05737732