Special Light Treatment for Multiple Myeloma

Recruiting at 1 trial location

Overseen By Mariana Figueiro, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Eye diseases, Secondary cancer, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 2 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of lighting can assist people with multiple myeloma undergoing a stem cell transplant. It seeks to determine if specific lighting can improve sleep patterns, reduce inflammation, and alleviate symptoms like fatigue or fever. Participants will receive either an effective lighting treatment (Circadian Effective Lighting) or an ineffective lighting treatment (Circadian Ineffective Lighting) for two months, while researchers monitor changes in sleep and health markers. This trial suits those diagnosed with multiple myeloma and preparing for their first stem cell transplant. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could enhance patient care.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this light treatment is safe for multiple myeloma patients?

Research has shown that circadian effective lighting, which influences the body's internal clock, is safe for people. In past studies, participants tolerated these light treatments well, experiencing no serious side effects. These studies often aim to improve sleep and reduce symptoms without causing harm. No major reports of negative effects have emerged, so current evidence generally considers the treatment safe. For any concerns or questions, discussing them with the trial team is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how light exposure might help manage multiple myeloma, a departure from the usual chemotherapy, immunotherapy, or targeted therapy treatments. The trial investigates whether specific light settings, called Circadian Effective Lighting (CEL), can positively influence the body’s biological clock, potentially enhancing patient well-being and treatment outcomes. Unlike traditional treatments that directly target cancer cells, this approach focuses on optimizing the patient's environment to support their natural rhythms, a novel angle that could complement existing therapies.

What evidence suggests that this trial's light treatments could be effective for multiple myeloma?

This trial will compare two lighting treatments for multiple myeloma patients: Circadian Effective Lighting (CEL) and Circadian Ineffective Lighting (CIL). Research has shown that special lighting mimicking natural light patterns, like CEL, can improve sleep and reduce symptoms in patients. Specifically, studies found that patients using this light therapy slept better and felt less affected by their symptoms. They slept more efficiently and had lower levels of inflammation in their blood. This lighting helps sync the body's internal clock, which can be especially beneficial for multiple myeloma patients undergoing treatments like stem cell transplants. These findings suggest that CEL could be a promising way to enhance patient well-being during treatment. ^{1 3 5 6 7}

Who Is on the Research Team?

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for adults over 21 with multiple myeloma who are English-speaking and ready for their first autologous stem cell transplant. They must be able to consent to the study. Those pregnant, with eye diseases affecting light processing, other recent cancers, severe sleep or psychological disorders, history of bipolar/manic episodes, past light therapy use or active infections like COVID-19 cannot join.

Inclusion Criteria

You must be proficient in English, able to communicate effectively.

I am 21 years old or older.

I am scheduled for my first stem cell transplant using my own cells.

Exclusion Criteria

You have a serious mental health condition.

I do not have an active infection, including COVID-19.

I have a severe sleep disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-Transplant Assessment

Participants are given an Actiwatch, Daysimeter, sleep logs, questionnaires, and a urine collection kit to assess melatonin. Blood sample for cytokine analyses is collected.

Up to 2 months

1 visit (in-person)

Treatment

Participants receive one of two different light-treatments designed to promote circadian rhythm alignment during the Autologous Stem Cell Transplantation.

2 months

Inpatient stay

Follow-up

Participants are monitored for changes in sleep efficiency, urine melatonin levels, blood inflammatory cytokine levels, and symptoms.

4 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Circadian Effective Lighting
• Circadian Ineffective Lightning (CIL)

Trial Overview The study tests two lighting conditions on circadian rhythm in multiple myeloma patients during stem cell transplantation. It aims to see if 'Circadian Effective Lighting' versus 'Circadian Ineffective Lighting' can improve sleep efficiency, melatonin levels in urine, reduce inflammation and symptom burden over two months.

How Is the Trial Designed?

Group I: Circadian Effective Lighting (CEL) Active Control 1 Intervention

The CEL will be performed in hospital sites over a 2-month period.

Group II: Circadian Ineffective Lighting (CIL) Placebo Group 1 Intervention

The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting.

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

Patients in an ICU room with a cycled lighting system reported a significantly better perception of daytime brightness compared to those in a standard lighting environment, indicating improved lighting conditions can enhance patient experience (n=48 for intervention room, n=52 for ordinary room).

Interviews with patients using the cycled lighting system (n=19) revealed that most felt it positively impacted their sleep and circadian rhythm, with many expressing feelings of calm and satisfaction, suggesting that such lighting interventions can be beneficial in critical care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lighting, sleep and circadian rhythm: An intervention study in the intensive care unit. Engwall, M., Fridh, I., Johansson, L., et al.[2016]

In a study involving 100 patients with cyclothymic axial syndrome, bright-light treatment was more effective than partial sleep deprivation, with a 60% response rate compared to 50%.

Bright-light treatment not only showed superior results on the Hamilton Depression Scale but was also effective for non-seasonal depressive disorders, particularly in younger patients with less severe depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of bright light therapy in cyclothymic axis syndromes--a cross-over study in comparison with partial sleep deprivation]. Heim, M.[2006]

Inappropriate light exposure in medical facilities can disrupt circadian rhythms and negatively impact patient health, particularly in settings like NICUs and ICUs.

Implementing cycled lighting and increasing sunlight exposure in these facilities has been linked to improved patient recovery and faster hospital discharge, highlighting the need for further research on optimal lighting conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Entrainment of the Human Circadian Clock to the Light-Dark Cycle and its Impact on Patients in the ICU and Nursing Home Settings. Ritchie, HK., Stothard, ER., Wright, KP.[2019]

Multiple myeloma arises from a premalignant tumor with shared genetic abnormalities, particularly involving the dysregulation of the cyclin D/retinoblastoma pathway, which is crucial for its development.

The disease is characterized by a complex interaction with the bone marrow microenvironment that leads to bone damage and contributes to drug resistance, highlighting the need for new therapeutic strategies despite recent advances that have improved survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular pathogenesis of multiple myeloma and its premalignant precursor. Kuehl, WM., Bergsagel, PL.[2021]

DETT effectively inhibits the NFκB signaling pathway by downregulating key proteins and promoting apoptosis in multiple myeloma cells, as demonstrated through various assays and immunoblotting techniques.

In animal studies, DETT showed the ability to delay tumor growth in multiple myeloma without causing significant toxicity, highlighting its potential as a safe therapeutic option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An anti-leishmanial thiadiazine agent induces multiple myeloma cell apoptosis by suppressing the nuclear factor kappaB signalling pathway. Chen, G., Han, K., Xu, X., et al.[2022]

Light exposure, especially when misaligned with natural rhythms, can disrupt circadian organization and hormone production, leading to sleep issues and metabolic problems.

Research is needed to understand the mechanisms of how light affects our biology, the consequences of circadian disruption on health, and how this knowledge can improve disease prevention and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meeting report: the role of environmental lighting and circadian disruption in cancer and other diseases. Stevens, RG., Blask, DE., Brainard, GC., et al.[2022]

The trial involving 54 psychiatric inpatients found that a circadian lighting environment did not significantly improve sleep quality or reduce depressive symptoms compared to standard lighting, as measured by the Pittsburgh Sleep Quality Index and other assessments.

Despite the lack of efficacy, the circadian lighting intervention was deemed safe, with no serious side effects reported and no patients requiring involuntary measures during the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lighting as an aid for recovery in hospitalized psychiatric patients: a randomized controlled effectiveness trial. Okkels, N., Jensen, LG., Skovshoved, LC., et al.[2020]

The SCID-hu myeloma model is unique as it allows primary human myeloma cells to grow in a human bone marrow environment, providing insights into the disease's biology and treatment.

This model effectively mimics myeloma characteristics, such as M protein production and bone damage, making it a valuable tool for studying myeloma therapies in vivo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The SCID-hu myeloma model. Epstein, J., Yaccoby, S.[2005]

A new classification system for multiple myeloma (MM) identifies two distinct subtypes based on the expression of a gene module associated with MCL1, which is crucial for plasma cell survival, allowing for better prediction of prognosis and response to bortezomib therapy.

This classification reveals that the two MM subtypes are linked to different plasma cell differentiation pathways, suggesting that understanding these pathways can lead to more personalized treatment strategies and insights into the disease's etiology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MCL1 gene co-expression module stratifies multiple myeloma and predicts response to proteasome inhibitor-based therapy. Samo, AA., Li, J., Zhou, M., et al.[2018]

Recent advances in understanding the biology of multiple myeloma have highlighted new therapeutic strategies that target both the cancer cells and their surrounding bone marrow environment.

These biologically based treatments aim to more effectively eliminate myeloma cells and maintain minimal residual disease, potentially leading to improved disease-free survival and a path towards a cure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel therapeutic targets in multiple myeloma. Davies, FE., Anderson, KC.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05737732?term=melatonin&cond=%22Hematologic%20Diseases%22&viewType=Table&rank=1

NCT05737732 | The Ambient Light Multiple Myeloma Study The aim of this multi-site randomized control trial will be is to assess the impact Systematic lighting on circadian rhythm entrainment, Inflammation, ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-00780

Circadian Effective Light Therapy for the Improvement of ... This phase III trial compares the effect of circadian effective light to circadian ineffective light for improving sleep and symptom burden in patients with ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6144249/

Programmed environmental illumination during autologous ... These findings demonstrate that PEI using BWL during MM ASCT hospitalization is effective in reducing the development of depression. Future studies should ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05737732/the-ambient-light-multiple-myeloma-study

The Ambient Light Multiple Myeloma Study The aim of this multi-site randomized control trial will be is to assess the impact Systematic lighting on circadian rhythm entrainment, ...

5. labs.icahn.mssm.edu labs.icahn.mssm.edu/reddlab/interventions/

Interventions | Program for Bio-Behavioral Light ... Data analyses performed on results from mixed group of cancer survivors (n=44). Participants in the circadian-effective condition had significant improvements ...

6. mountsinai.org mountsinai.org/clinical-trials/ambient-light-multiple-myeloma-study

The Ambient Light Multiple Myeloma Study The aim of this multi-site randomized control trial will be is to assess the impact Systematic lighting on circadian rhythm entrainment, Inflammation, ...

7. reporter.nih.gov reporter.nih.gov/project-details/11137688

Project Details - NIH RePORTER PROJECT NARRATIVE The proposed R01 investigates the effects of circadian-effective light on Multiple Myeloma patients receiving Autologous Stem Cell ...