Special Light Treatment for Multiple Myeloma

Recruiting at1 trial location

Overseen by Mariana Figueiro, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Eye diseases, Secondary cancer, Bipolar, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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.

Is the special light treatment generally safe for humans?

Research on various forms of light treatment, including circadian lighting, suggests it is generally safe for humans. Studies in different settings, such as ICUs and psychiatric wards, have shown no serious side effects and have been well-received by patients. ^{1 2 3 4 5}

How does the Special Light Treatment for Multiple Myeloma differ from other treatments?

The Special Light Treatment for Multiple Myeloma, known as Circadian Effective Lighting, is unique because it uses light therapy to potentially influence the body's natural rhythms, unlike traditional drug-based treatments that target cancer cells directly. This approach may offer a novel way to manage symptoms or improve quality of life by aligning with the body's circadian (daily) cycles. ^{6 7 8 9 10}

Research Team

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Circadian Effective Lighting (Behavioural Intervention)
• Circadian Ineffective Lightning (CIL) (Behavioural Intervention)

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.

Participant Groups

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+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

Findings from Research

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]

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 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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Lighting, sleep and circadian rhythm: An intervention study in the intensive care unit. [2016]

2. Germany pubmed.ncbi.nlm.nih.gov

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

3. United Arab Emirates 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. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Meeting report: the role of environmental lighting and circadian disruption in cancer and other diseases. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Lighting as an aid for recovery in hospitalized psychiatric patients: a randomized controlled effectiveness trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

The SCID-hu myeloma model. [2005]

7. United States pubmed.ncbi.nlm.nih.gov

MCL1 gene co-expression module stratifies multiple myeloma and predicts response to proteasome inhibitor-based therapy. [2018]

8. England pubmed.ncbi.nlm.nih.gov

An anti-leishmanial thiadiazine agent induces multiple myeloma cell apoptosis by suppressing the nuclear factor kappaB signalling pathway. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Novel therapeutic targets in multiple myeloma. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Molecular pathogenesis of multiple myeloma and its premalignant precursor. [2021]