AzTrials
AzTrials

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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

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.

Barbara Plitnick, BSN contact

518 242-4603

Barbara.Plitnick@mountsinai.org

Mariana Figueiro, PhD contact

518-366-9306

Mariana.Figueiro@mountsinai.org

United States2 sites, 2 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

    Recruiting

Other trials in United States

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.

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 groups in NCT05737732
Study groupRoleWhat they receive
Circadian Effective Lighting (CEL)Active comparatorThe CEL will be performed in hospital sites over a 2-month period.
Receives: Device: Circadian Effective Lighting
Circadian Ineffective Lighting (CIL)Sham comparatorThe 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.

  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).

    Measured: Baseline visit and 3 days after the Autologous Stem Cell Transplant

Secondary outcomes (29)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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.

  1. First posted21 Feb 2023
  2. Study start13 Feb 2023
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion30 Jun 2027 (estimated)

Resources

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)
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.

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.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in