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

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.

Study Overview

• Status: Recruiting
• Conditions: Multiple Myeloma
• Intervention / Treatment: Device: Circadian Effective Lighting; Device: Circadian Ineffective Lightning (CIL)

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariana Figueiro, PhD; Phone Number: 518-366-9306; Email: Mariana.Figueiro@mountsinai.org
• Study Contact Backup: Name: Barbara Plitnick, BSN; Phone Number: 518 242-4603; Email: Barbara.Plitnick@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Recruiting
      • Memorial Sloan Kettering Cancer Center
      • Contact: Sergio Giralt, MD; Email: giralts@mskcc.org
      • Principal Investigator: Sergio Giralt
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn Schoool of Medicine at Mount Sinai
      • Contact: Mariana Figueiro, PhD; Phone Number: 518-366-9306; Email: Mariana.Figueiro@mountsinai.org
      • Contact: Barbara Plitnick, BSN; Phone Number: 518-242-4603; Email: barbara.plitnick@mountsinai.org
      • Principal Investigator: Mariana Figueiro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Circadian Effective Lighting (CEL); The CEL will be performed in hospital sites over a 2-month period.	Device: Circadian Effective Lighting; 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.
Sham Comparator: Circadian Ineffective Lighting (CIL); The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting.	Device: Circadian Ineffective Lightning (CIL); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep Efficiency using Actigraphy at 7 days post-transplant	The participant will be asked to wear a wrist actigraph to monitoring sleep and activity, daily for 5 consecutive days. From the actigraphy data, change in sleep efficiency will be calculated. A higher sleep efficiency indicates improved sleep.	at 7 days post-transplant
Sleep Efficiency using Actigraphy at 3 days after engraftment	The participant will be asked to wear a wrist actigraph to monitoring sleep and activity, daily for 5 consecutive days. From the actigraphy data, change in sleep efficiency will be calculated. A higher sleep efficiency indicates improved sleep.	at 3 days after engraftment
Sleep Efficiency using Actigraphy at 4 weeks after engraftment	The participant will be asked to wear a wrist actigraph to monitoring sleep and activity, daily for 5 consecutive days. From the actigraphy data, change in sleep efficiency will be calculated. A higher sleep efficiency indicates improved sleep.	at 4 weeks after engraftment
Inflammatory cytokine CRP levels at Baseline	A blood sample will be drawn to measure Inflammatory cytokine CRP levels. A decrease in CRP levels indicates reduced inflammation.	At baseline, or during the hospital visit prior to transplant
Inflammatory cytokine CRP levels at 7 days following transplant	A blood sample will be drawn to measure Inflammatory cytokine CRP levels. A decrease in CRP levels indicates reduced inflammation.	at 7 days following transplant
Inflammatory cytokine CRP levels at 3 days following engraftment	A blood sample will be drawn to measure Inflammatory cytokine CRP levels. A decrease in CRP levels indicates reduced inflammation.	at 3 days following engraftment
Inflammatory cytokine CRP levels at 4 weeks following engraftment	A blood sample will be drawn to measure Inflammatory cytokine CRP levels. A decrease in CRP levels indicates reduced inflammation.	at 4 weeks following engraftment
Number of Neutropenic Fevers at 7 days post-transplant	Physician notes on patient neutropenic fever will be obtained from medical records. Neutropenic fever will be defined as temperature of 38.2 C or higher and an absolute neutrophil count of less than 500 cells/mm. Physician notes are reviewed, and the number of times neutropenic fever is reported for each participant is recorded.	at 7 days post-transplant
Number of Neutropenic Fevers at 3 days after engraftment	Physician notes on patient neutropenic fever will be obtained from medical records. Neutropenic fever will be defined as temperature of 38.2 C or higher and an absolute neutrophil count of less than 500 cells/mm. Physician notes are reviewed, and the number of times neutropenic fever is reported for each participant is recorded.	at 3 days after engraftment
Number of Neutropenic Fevers at 4 weeks after engraftment	Physician notes on patient neutropenic fever will be obtained from medical records. Neutropenic fever will be defined as temperature of 38.2 C or higher and an absolute neutrophil count of less than 500 cells/mm. Physician notes are reviewed, and the number of times neutropenic fever is reported for each participant is recorded.	at 4 weeks after engraftment
Circadian Light levels measured with Daysimeter (light monitor) at 7 days post-transplant	Participants will be asked to wear Daysimeters as a pendant or a pin during all waking times during the intervention weeks. Light measurements from Daysimeters used as pendants or pins are the closest to light measurements at eye level. The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the intervention weeks.	at 7 days post-transplant
Circadian Light levels measured with Daysimeter (light monitor) at 3 days after engraftment	Participants will be asked to wear Daysimeters as a pendant or a pin during all waking times during the intervention weeks. Light measurements from Daysimeters used as pendants or pins are the closest to light measurements at eye level. The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the intervention weeks.	at 3 days after engraftment
Circadian Light levels measured with Daysimeter (light monitor) at 4 weeks after engraftment	Participants will be asked to wear Daysimeters as a pendant or a pin during all waking times during the intervention weeks. Light measurements from Daysimeters used as pendants or pins are the closest to light measurements at eye level. The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the intervention weeks.	at 4 weeks after engraftment
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at Baseline	MDASI-MM, with well-established reliability and validity, is 19-item measure of cancer-related symptom burden. It assesses 13 core symptoms common across cancer types and treatments (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness/tingling). In addition, 6 items assess symptom-related interference. All 19 items are rated with reference to "the last 24 hours" on a scale from 0 to 10 with anchors at the extreme ends of the scale (for symptom items, 0 = "Not Present" and 10 = "As Bad As You Can Imagine"; for interference items 0 = "Did Not Interfere" and 10 = "Interfered Completely. Higher scores indicate higher symptom interference. The MDASI-Multiple Myeloma (MM) is the MDASI plus 7 additional items assessing symptoms specific to patients with MM (constipation, muscle weakness, diarrhea, sore mouth/throat, rash, difficulty concentrating and bone aches).	At baseline, or during the hospital visit prior to transplant
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 7 days following transplant	MDASI-MM, with well-established reliability and validity, is 19-item measure of cancer-related symptom burden. It assesses 13 core symptoms common across cancer types and treatments (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness/tingling). In addition, 6 items assess symptom-related interference. All 19 items are rated with reference to "the last 24 hours" on a scale from 0 to 10 with anchors at the extreme ends of the scale (for symptom items, 0 = "Not Present" and 10 = "As Bad As You Can Imagine"; for interference items 0 = "Did Not Interfere" and 10 = "Interfered Completely. Higher scores indicate higher symptom interference. The MDASI-Multiple Myeloma (MM) is the MDASI plus 7 additional items assessing symptoms specific to patients with MM (constipation, muscle weakness, diarrhea, sore mouth/throat, rash, difficulty concentrating and bone aches).	at 7 days following transplant
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 3 days following engraftment	MDASI-MM, with well-established reliability and validity, is 19-item measure of cancer-related symptom burden. It assesses 13 core symptoms common across cancer types and treatments (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness/tingling). In addition, 6 items assess symptom-related interference. All 19 items are rated with reference to "the last 24 hours" on a scale from 0 to 10 with anchors at the extreme ends of the scale (for symptom items, 0 = "Not Present" and 10 = "As Bad As You Can Imagine"; for interference items 0 = "Did Not Interfere" and 10 = "Interfered Completely. Higher scores indicate higher symptom interference. The MDASI-Multiple Myeloma (MM) is the MDASI plus 7 additional items assessing symptoms specific to patients with MM (constipation, muscle weakness, diarrhea, sore mouth/throat, rash, difficulty concentrating and bone aches).	at 3 days following engraftment
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 4 weeks following engraftment	MDASI-MM, with well-established reliability and validity, is 19-item measure of cancer-related symptom burden. It assesses 13 core symptoms common across cancer types and treatments (pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, difficulty remembering, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness/tingling). In addition, 6 items assess symptom-related interference. All 19 items are rated with reference to "the last 24 hours" on a scale from 0 to 10 with anchors at the extreme ends of the scale (for symptom items, 0 = "Not Present" and 10 = "As Bad As You Can Imagine"; for interference items 0 = "Did Not Interfere" and 10 = "Interfered Completely. Higher scores indicate higher symptom interference. The MDASI-Multiple Myeloma (MM) is the MDASI plus 7 additional items assessing symptoms specific to patients with MM (constipation, muscle weakness, diarrhea, sore mouth/throat, rash, difficulty concentrating and bone aches).	at 4 weeks following engraftment
Perceived Stress Scale Score at Baseline	Perceived Stress Scale is a 10-item self-report questionnaire that measures a person's self-reported evaluation of their perception of stressfulness in a situation over the past 1 month of their lives. It assesses a person's feelings and thoughts over a 1-month period. Participants rate each item on a 4-point scale (0 = "never," 1 = "almost never," 2 = "sometimes," 3 = "fairly often," 4 = "often") producing scores ranging from 0-40. Scores are obtained by reversing the scores on items 4,5,7 and 8 like so: 0=1,1=3,2=2,3=1,4=0, and then adding up the scores for each item to obtain a total score. Higher scores indicate greater stress.	At baseline, or during the hospital visit prior to transplant
Perceived Stress Scale Score at 7 days post-transplant	Perceived Stress Scale is a 10-item self-report questionnaire that measures a person's self-reported evaluation of their perception of stressfulness in a situation over the past 1 month of their lives. It assesses a person's feelings and thoughts over a 1-month period. Participants rate each item on a 4-point scale (0 = "never," 1 = "almost never," 2 = "sometimes," 3 = "fairly often," 4 = "often") producing scores ranging from 0-40. Scores are obtained by reversing the scores on items 4,5,7 and 8 like so: 0=1,1=3,2=2,3=1,4=0, and then adding up the scores for each item to obtain a total score. Higher scores indicate greater stress.	at 7 days post-transplant
Perceived Stress Scale Score at 3 days following engraftment	Perceived Stress Scale is a 10-item self-report questionnaire that measures a person's self-reported evaluation of their perception of stressfulness in a situation over the past 1 month of their lives. It assesses a person's feelings and thoughts over a 1-month period. Participants rate each item on a 4-point scale (0 = "never," 1 = "almost never," 2 = "sometimes," 3 = "fairly often," 4 = "often") producing scores ranging from 0-40. Scores are obtained by reversing the scores on items 4,5,7 and 8 like so: 0=1,1=3,2=2,3=1,4=0, and then adding up the scores for each item to obtain a total score. Higher scores indicate greater stress.	at 3 days following engraftment
Perceived Stress Scale Score at 4 weeks following engraftment	Perceived Stress Scale is a 10-item self-report questionnaire that measures a person's self-reported evaluation of their perception of stressfulness in a situation over the past 1 month of their lives. It assesses a person's feelings and thoughts over a 1-month period. Participants rate each item on a 4-point scale (0 = "never," 1 = "almost never," 2 = "sometimes," 3 = "fairly often," 4 = "often") producing scores ranging from 0-40. Scores are obtained by reversing the scores on items 4,5,7 and 8 like so: 0=1,1=3,2=2,3=1,4=0, and then adding up the scores for each item to obtain a total score. Higher scores indicate greater stress.	at 4 weeks following engraftment
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at Baseline	Participants will complete the 8-item PROMIS Sleep Disturbance Short Form (PROMIS-SD) during assessment periods to assess the pure domain of sleep disturbances among adults ages 18 and older. Participants rate each item on a 5-point scale (1 = "never," 2 = "rarely," 3 = "sometimes," 4 = "often," 5 = "always"), producing scores ranging from 8-40. Raw scores for the 8 items are summed for a global score; higher scores indicate greater severity of sleep disturbance.	At baseline, or during the hospital visit prior to transplant
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 7 days post-engraftment	Participants will complete the 8-item PROMIS Sleep Disturbance Short Form (PROMIS-SD) during assessment periods to assess the pure domain of sleep disturbances among adults ages 18 and older. Participants rate each item on a 5-point scale (1 = "never," 2 = "rarely," 3 = "sometimes," 4 = "often," 5 = "always"), producing scores ranging from 8-40. Raw scores for the 8 items are summed for a global score; higher scores indicate greater severity of sleep disturbance.	at 7 days following transplant
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 3 days following engraftment	Participants will complete the 8-item PROMIS Sleep Disturbance Short Form (PROMIS-SD) during assessment periods to assess the pure domain of sleep disturbances among adults ages 18 and older. Participants rate each item on a 5-point scale (1 = "never," 2 = "rarely," 3 = "sometimes," 4 = "often," 5 = "always"), producing scores ranging from 8-40. Raw scores for the 8 items are summed for a global score; higher scores indicate greater severity of sleep disturbance.	at 3 days following engraftment
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 4 weeks following engraftment	Participants will complete the 8-item PROMIS Sleep Disturbance Short Form (PROMIS-SD) during assessment periods to assess the pure domain of sleep disturbances among adults ages 18 and older. Participants rate each item on a 5-point scale (1 = "never," 2 = "rarely," 3 = "sometimes," 4 = "often," 5 = "always"), producing scores ranging from 8-40. Raw scores for the 8 items are summed for a global score; higher scores indicate greater severity of sleep disturbance.	at 4 weeks following engraftment
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at Baseline	Participants, 18 years and older, will complete the 13-item PROMIS Fatigue Short Form items which asses a range of self-reported symptoms of fatigue from mild feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that decreases one's ability to execute daily activities and function normally in family or social roles. On the form, Participant Fatigue is divided by the impact of fatigue on physical, mental, and social activities. All items assess fatigue over the past 7 days. Participants will rate each item on a 5-point scale (1= "Not at all", 2= "A little bit", 3= "Somewhat", 4= "Quite a bit", 5= "Very much"). Scores will be summed to produce a total or raw score ranging from 8. (lowest score) to 40, with a higher score indicating more frequent fatigue. If all questions were responded to, a scoring table will be used to generate the T-score.	At baseline, or during the hospital visit prior to transplant
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 7 days following transplant	Participants, 18 years and older, will complete the 13-item PROMIS Fatigue Short Form items which asses a range of self-reported symptoms of fatigue from mild feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that decreases one's ability to execute daily activities and function normally in family or social roles. On the form, Participant Fatigue is divided by the impact of fatigue on physical, mental, and social activities. All items assess fatigue over the past 7 days. Participants will rate each item on a 5-point scale (1= "Not at all", 2= "A little bit", 3= "Somewhat", 4= "Quite a bit", 5= "Very much"). Scores will be summed to produce a total or raw score ranging from 8. (lowest score) to 40, with a higher score indicating more frequent fatigue. If all questions were responded to, a scoring table will be used to generate the T-score.	at 7 days following transplant
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 3 days following engraftment	Participants, 18 years and older, will complete the 13-item PROMIS Fatigue Short Form items which asses a range of self-reported symptoms of fatigue from mild feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that decreases one's ability to execute daily activities and function normally in family or social roles. On the form, Participant Fatigue is divided by the impact of fatigue on physical, mental, and social activities. All items assess fatigue over the past 7 days. Participants will rate each item on a 5-point scale (1= "Not at all", 2= "A little bit", 3= "Somewhat", 4= "Quite a bit", 5= "Very much"). Scores will be summed to produce a total or raw score ranging from 8. (lowest score) to 40, with a higher score indicating more frequent fatigue. If all questions were responded to, a scoring table will be used to generate the T-score.	at 3 days following engraftment
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 4 weeks following engraftment	Participants, 18 years and older, will complete the 13-item PROMIS Fatigue Short Form items which asses a range of self-reported symptoms of fatigue from mild feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that decreases one's ability to execute daily activities and function normally in family or social roles. On the form, Participant Fatigue is divided by the impact of fatigue on physical, mental, and social activities. All items assess fatigue over the past 7 days. Participants will rate each item on a 5-point scale (1= "Not at all", 2= "A little bit", 3= "Somewhat", 4= "Quite a bit", 5= "Very much"). Scores will be summed to produce a total or raw score ranging from 8. (lowest score) to 40, with a higher score indicating more frequent fatigue. If all questions were responded to, a scoring table will be used to generate the T-score.	at 4 weeks following engraftment

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Mariana Figueiro, PhD, Icahn School Of Medicine At Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: February 10, 2023
• First Submitted That Met QC Criteria: February 10, 2023
• First Posted (Actual): February 21, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2025
• Last Update Submitted That Met QC Criteria: May 28, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Multiple Myeloma; Neoplasms, Plasma Cell
• Other Study ID Numbers: STUDY-21-01146

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No