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

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Bone Marrow Aspirate and Biopsy — PROCEDURE
    The 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

Locations (1)

FacilityCityStateZIPSite coordinators
University of IowaIowa CityIowa52242
Michael Tomasson, MD
319-356-4200

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