Sleep Apnea in Patients With MGUS and MM
Part of paid clinical trials in Iowa City, Iowa.
- Sponsor
- Michael Tomasson
- Study ID
- NCT04114084
- Status
- Recruiting
Conditions
- Monoclonal Gammopathy of Undetermined Significance
- Multiple Myeloma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 99 Years
- Healthy Volunteers
- Not accepted
Interventions
- Bone Marrow Aspirate and Biopsy — PROCEDUREThe 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.
Study Details
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.
Key Dates
- Start date
- May 23, 2019
- Status verified
- Nov 2025
- Primary completion
- May 23, 2030
- Completion
- May 23, 2030
Study Design
- Enrollment
- 200 participants (estimated)
Arms
- Arm: A. patients with MGUS and sleep apnea
- Arm: B. patients with MGUS and no sleep apnea
- Arm: C. patients with MM and sleep apnea
- Arm: D. patients with MM and no sleep apnea
Primary Outcome Measure
To quantify the incidence of sleep apnea and sleep disorder in patients with MGUS and MM [ Time Frame: From study initiation up to 5 years ]
Central Contacts
- Michael Tomasson, MD319-356-4200
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 |
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