The Ambient Light Multiple Myeloma Study

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05737732
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Circadian Effective Lighting — DEVICE
    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 Details

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.

Key Dates

Start date
Feb 13, 2023
Status verified
May 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Circadian Effective Lighting (CEL)
    The CEL will be performed in hospital sites over a 2-month period.
  • Sham Comparator: Circadian Ineffective Lighting (CIL)
    The comparator lighting will be performed identical to Arm 1, at specified lower levels of lighting.

Primary Outcome Measure

Changes in Urinary Melatonin [ Time Frame: Baseline visit and 3 days after the Autologous Stem Cell Transplant ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Icahn Schoool of Medicine at Mount SinaiNew YorkNew York10029
Mariana Figueiro, PhD
[email protected]
518-366-9306
Barbara Plitnick, BSN
[email protected]
518-242-4603
Mariana Figueiro (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Sergio Giralt, MD
[email protected]
Sergio Giralt (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Icahn Schoool of Medicine at Mount Sinai· New York, NYMemorial Sloan Kettering Cancer Center· New York, NY

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