Multiple MyelomaNCT05737732
The Ambient Light Multiple Myeloma Study
A study testing Circadian Effective Lighting and Circadian Ineffective Lightning (CIL) in people with Multiple Myeloma, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Circadian Effective Lighting and Circadian Ineffective Lightning (CIL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Feb 2023to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Multiple Myeloma diagnosis
- Scheduled to undergo their first Autologous Stem Cell Transplant procedure.
- 21years or older
- Able to provide informed consent.
- English-language proficient
Who cannot join
- 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
Show all 9Show fewer
- Severe psychological impairment
- Previous use of light therapy
- Active infection including COVID-19 infection
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Icahn Schoool of Medicine at Mount Sinai
New York, New York, 10029
Mariana Figueiro, PhD, 518-366-9306, mariana.figueiro@mountsinai.org
Barbara Plitnick, BSN, 518-242-4603, Barbara.Plitnick@mountsinai.org
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Sergio Giralt, MD, giralts@mskcc.org
Sergio Giralt
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Circadian Effective Lighting, Circadian Ineffective Lightning (CIL)
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian Effective LightingDevice
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.
Circadian Ineffective Lightning (CIL)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Circadian Effective Lighting (CEL) | Active comparator | The CEL will be performed in hospital sites over a 2-month period. Receives: Device: Circadian Effective Lighting |
| Circadian Ineffective Lighting (CIL) | Sham comparator | The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting. Receives: Device: Circadian Ineffective Lightning (CIL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline visit and 3 days after the Autologous Stem Cell Transplant
Secondary outcomes (29)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at 4 weeks following engraftment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start13 Feb 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Figueiro, Icahn School of Medicine at Mount Sinai
- Investigators
- Mariana Figueiro, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05737732
- Sponsor's protocol ID
- STUDY-21-01146
- Status last verified
- Jun 2026
- First submitted
- 10 Feb 2023
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Light Exposure Effects on Circadian Rhythms Entrainment, Inflammation, Neutropenic Fever and Symptom Burden Among Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT05737732
- Acronym / sponsor ID
- STUDY-21-01146
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 13 Feb 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Circadian Effective Lighting (CEL) | Active comparator | Device: Circadian Effective LightingThe CEL will be performed in hospital sites over a 2-month period. |
| Circadian Ineffective Lighting (CIL) | Sham comparator | Device: Circadian Ineffective Lightning (CIL)The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Multiple Myeloma diagnosis
- Scheduled to undergo their first Autologous Stem Cell Transplant procedure.
- 21years or older
- Able to provide informed consent.
- English-language proficient
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Circadian Effective LightingParticipants 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. | Device | Circadian Effective Lighting (CEL) |
| 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. | Device | Circadian Ineffective Lighting (CIL) |
Primary outcome
Changes in Urinary Melatonin
Time frame: Baseline visit and 3 days after the Autologous Stem Cell Transplant
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).
29 secondary outcomes
Sleep Efficiency using Actigraphy at 7 days post-transplant
Time frame: at 7 days post-transplant
Sleep Efficiency using Actigraphy at 3 days after engraftment
Time frame: at 3 days after engraftment
Sleep Efficiency using Actigraphy at 4 weeks after engraftment
Time frame: at 4 weeks after engraftment
Inflammatory cytokine CRP levels at Baseline
Time frame: At baseline, or during the hospital visit prior to transplant
Inflammatory cytokine CRP levels at 7 days following transplant
Time frame: at 7 days following transplant
Inflammatory cytokine CRP levels at 3 days following engraftment
Time frame: at 3 days following engraftment
Inflammatory cytokine CRP levels at 4 weeks following engraftment
Time frame: at 4 weeks following engraftment
Number of Neutropenic Fevers at 7 days post-transplant
Time frame: at 7 days post-transplant
Number of Neutropenic Fevers at 3 days after engraftment
Time frame: at 3 days after engraftment
Number of Neutropenic Fevers at 4 weeks after engraftment
Time frame: at 4 weeks after engraftment
Circadian Light levels measured with Daysimeter (light monitor) at 7 days post-transplant
Time frame: at 7 days post-transplant
Circadian Light levels measured with Daysimeter (light monitor) at 3 days after engraftment
Time frame: at 3 days after engraftment
Circadian Light levels measured with Daysimeter (light monitor) at 4 weeks after engraftment
Time frame: at 4 weeks after engraftment
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at Baseline
Time frame: At baseline, or during the hospital visit prior to transplant
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 7 days following transplant
Time frame: at 7 days following transplant
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 3 days following engraftment
Time frame: at 3 days following engraftment
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 4 weeks following engraftment
Time frame: at 4 weeks following engraftment
Perceived Stress Scale Score at Baseline
Time frame: At baseline, or during the hospital visit prior to transplant
Perceived Stress Scale Score at 7 days post-transplant
Time frame: at 7 days post-transplant
Perceived Stress Scale Score at 3 days following engraftment
Time frame: at 3 days following engraftment
Perceived Stress Scale Score at 4 weeks following engraftment
Time frame: at 4 weeks following engraftment
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at Baseline
Time frame: 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
Time frame: at 7 days following transplant
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 3 days following engraftment
Time frame: at 3 days following engraftment
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 4 weeks following engraftment
Time frame: at 4 weeks following engraftment
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at Baseline
Time frame: At baseline, or during the hospital visit prior to transplant
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 7 days following transplant
Time frame: at 7 days following transplant
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 3 days following engraftment
Time frame: at 3 days following engraftment
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 4 weeks following engraftment
Time frame: at 4 weeks following engraftment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mariana Figueiro, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian Effective Lighting and Circadian Ineffective Lightning (CIL) in people with Multiple Myeloma, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Plitnick, BSN (518 242-4603, Barbara.Plitnick@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Urinary Melatonin (time frame: Baseline visit and 3 days after the Autologous Stem Cell Transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.