Multiple Myeloma Clinical Trial

The Ambient Light Multiple Myeloma Study

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. 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.

View Full Description

Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Multiple Myeloma diagnosis
Scheduled to undergo their first Autologous Stem Cell Transplant procedure.
21years or older
Able to provide informed consent.
English-language proficient

Exclusion Criteria:

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
Severe psychological impairment
Previous use of light therapy
Active infection including COVID-19 infection

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

200

Study ID:

NCT05737732

Recruitment Status:

Recruiting

Sponsor:

Icahn School of Medicine at Mount Sinai

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 2 Locations for this study

See Locations Near You

Icahn Schoool of Medicine at Mount Sinai
New York New York, 10029, United States More Info
Mariana Figueiro, PhD
Contact
518-366-9306
[email protected]
Barbara Plitnick, BSN
Contact
518-242-4603
[email protected]
Mariana Figueiro
Principal Investigator
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States More Info
Sergio Giralt, MD
Contact
[email protected]
Sergio Giralt
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Estimated Enrollment:

200

Study ID:

NCT05737732

Recruitment Status:

Recruiting

Sponsor:


Icahn School of Medicine at Mount Sinai

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider