Sleep Apnea in Patients With MGUS and MM
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 23, 2019
CompletedFirst Submitted
Initial submission to the registry
October 1, 2019
CompletedFirst Posted
Study publicly available on registry
October 3, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 23, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 23, 2030
November 10, 2025
November 1, 2025
11 years
October 1, 2019
November 5, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
To quantify the incidence of sleep apnea and sleep disorder in patients with MGUS and MM
From study initiation up to 5 years
To compare gene expression in bone marrow stroma of MGUS and MM patients, with and without sleep apnea, and following sleep apnea treatment.
From study initiation up to 5 years
Study Arms (4)
A. patients with MGUS and sleep apnea
B. patients with MGUS and no sleep apnea
C. patients with MM and sleep apnea
D. patients with MM and no sleep apnea
Interventions
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.
Eligibility Criteria
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
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
- Michael Tomassonlead
- Department of Health and Human Servicescollaborator
Study Sites (1)
University of Iowa
Iowa City, Iowa, 52242, United States
Biospecimen
Whole exome, genome wide and RNA sequencing
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Tomasson, MD
University of Iowa
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor of Internal Medicine
Study Record Dates
First Submitted
October 1, 2019
First Posted
October 3, 2019
Study Start
May 23, 2019
Primary Completion (Estimated)
May 23, 2030
Study Completion (Estimated)
May 23, 2030
Last Updated
November 10, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share