Sleep Apnea in Patients With MGUS and MM
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorMichael Tomasson
About this trial
This study involves patients with plasma cell dyscrasia including monoclonal gammopathy of undetermined significance (MGUS) or multiple myeloma (MM), with and without sleep apnea, who are providing bone marrow specimens. Specimens will be obtained at the time that patients undergo a standard-of-care procedure in order to minimize discomfort and reduce any risk.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients diagnosed with MGUS or MM who will be receiving a bone marrow biopsy as part of their standard of care with and without sleep apnea
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Bone Marrow Aspirate and Biopsy
Procedure/SurgeryThe aspirate sample obtained for research at the time a standard-of-care biopsy is taking place will be approximately 40cc. Bone marrow aspiration removes bone marrow fluid and cells through a needle placed into the bone. Usually this sample is taken from the back of the pelvic bone, but it may also be taken from the sternum or the front of the pelvic bone. A bone marrow biopsy removes bone with the marrow inside and is done prior to the aspirate. Each biopsy and aspirate procedure takes approximately 15 minutes total. Bone marrow aspirate may be collected in a separate tube for research or collected from the standard-of-care specimen with left-over aspirate not otherwise needed for clinical purposes, or from previous procedures.
Treatment groups
200 Participants
are divided into 4 treatment groupsGroup A: A. patients with MGUS and sleep apnea1 intervention
Group B: B. patients with MGUS and no sleep apnea1 intervention
Group C: C. patients with MM and sleep apnea1 intervention
Group D: D. patients with MM and no sleep apnea1 intervention
Trial outcomes
Primary outcomes
1
To quantify the incidence of sleep apnea and sleep disorder in patients with MGUS and MM
Time frame
From study initiation up to 5 years2
To compare gene expression in bone marrow stroma of MGUS and MM patients, with and without sleep apnea, and following sleep apnea treatment.
Time frame
From study initiation up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Michael Tomasson
Lead sponsor
University of Iowa
Sponsor institution
Department of Health and Human Services
Collaborator
Source ClinicalTrials.gov