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Circadian Effective Lighting (CEL) for Multiple Myeloma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Memorial Sloan Kettering Cancer Center, New York, NYMultiple MyelomaCircadian Effective Lighting - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test how a special light treatment can help Multiple Myeloma patients with their sleep, inflammation and symptoms. 200 people will receive this light over a 2-month period.

Eligible Conditions
  • Multiple Myeloma

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
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2
Cilta-cel

Study Objectives

1 Primary · 29 Secondary · Reporting Duration: at 3 days following engraftment

At baseline, or during the hospital visit prior to transplant
Inflammatory cytokine CRP levels at Baseline
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at Baseline
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at Baseline
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at Baseline
Perceived Stress Scale Score at Baseline
Day 3
Changes in Urinary Melatonin
Day 3
Circadian Light levels measured with Daysimeter (light monitor) at 3 days after engraftment
Number of Neutropenic Fevers at 3 days after engraftment
Sleep Efficiency using Actigraphy at 3 days after engraftment
Day 3
Inflammatory cytokine CRP levels at 3 days following engraftment
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 3 days following engraftment
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 3 days following engraftment
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 3 days following engraftment
Perceived Stress Scale Score at 3 days following engraftment
Week 4
Circadian Light levels measured with Daysimeter (light monitor) at 4 weeks after engraftment
Number of Neutropenic Fevers at 4 weeks after engraftment
Sleep Efficiency using Actigraphy at 4 weeks after engraftment
Week 4
Inflammatory cytokine CRP levels at 4 weeks following engraftment
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 4 weeks following engraftment
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 4 weeks following engraftment
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 4 weeks following engraftment
Perceived Stress Scale Score at 4 weeks following engraftment
Day 7
Inflammatory cytokine CRP levels at 7 days following transplant
MD Anderson Symptom Inventory Score-Multiple Myeloma (MDASI-MM) at 7 days following transplant
Patient-Reported Outcomes Measurement Information System (PROMIS)- Fatigue Score at 7 days following transplant
Patient-Reported Outcomes Measurement Information System -Sleep Disturbance Short Form (PROMIS-SD) Score at 7 days post-engraftment
at 7 days post-transplant
Circadian Light levels measured with Daysimeter (light monitor) at 7 days post-transplant
Number of Neutropenic Fevers at 7 days post-transplant
Perceived Stress Scale Score at 7 days post-transplant
Sleep Efficiency using Actigraphy at 7 days post-transplant

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
Ide-cel (bb2121)
2
Budesonide EC
3
Cilta-cel

Trial Design

2 Treatment Groups

Circadian Effective Lighting (CEL)
1 of 2
Circadian Ineffective Lighting (CIL)
1 of 2

Active Control

Non-Treatment Group

200 Total Participants · 2 Treatment Groups

Primary Treatment: Circadian Effective Lighting (CEL) · Has Placebo Group · N/A

Circadian Ineffective Lighting (CIL)
Device
ShamComparator Group · 1 Intervention: Circadian Ineffective Lightning (CIL) · Intervention Types: Device
Circadian Effective Lighting (CEL)
Device
ActiveComparator Group · 1 Intervention: Circadian Effective Lighting · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at 3 days following engraftment

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor
790 Previous Clinical Trials
508,759 Total Patients Enrolled
8 Trials studying Multiple Myeloma
1,286 Patients Enrolled for Multiple Myeloma
Mariana Figueiro, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
7 Previous Clinical Trials
563 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are going to have your first autologous stem cell transplant.

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
How many prior treatments have patients received?
0100.0%
What state do they live in?
California100.0%
References

Frequently Asked Questions

Are researchers still accepting participants for this experiment?

"Affirmative. According to the information on clinicaltrials.gov, this medical experiment is actively recruiting participants after its initial posting on February 1st 2023 and most recent edit of February 10th 2023. Two hundred patients need to be recruited from two different sites for this trial." - Anonymous Online Contributor

Unverified Answer

How many individuals are being recruited to partake in this investigation?

"Indeed, the data on clinicaltrials.gov verifies that this trial is actively recruiting participants. This medical investigation was initially presented to the public on February 1st 2023 and has been updated as recently as February 10th 2023. The research team aims to include 200 subjects from 2 different sites in their study." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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