Multiple MyelomaNCT04114084
Sleep Apnea in Patients With MGUS and MM
An observational study of Multiple Myeloma and Monoclonal Gammopathy of Undetermined Significance, run by Michael Tomasson at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
- What is being tested?
- Bone Marrow Aspirate and Biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2019to 23 May 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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
Patients diagnosed with MGUS or MM who will be receiving a bone marrow biopsy as part of their standard of care are eligible to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Iowa
Iowa City, Iowa, 52242
Michael Tomasson, MD, 319-356-4200, michael-tomasson@uiowa.edu
About this study
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.
Read the detailed description
Obesity is a risk factor for the development of MM, although the mechanisms that link obesity and MM are unclear. Obesity, in turn, is closely associated with obstructive sleep apnea. Interestingly, the key risk factors for both sleep apnea and MM are overlapping (age, sex, race and body mass index). During the apnea, or cessation of normal breathing, arterial oxygen saturation falls. This can occur as often as 60 times per hour, resulting in chronic intermittent hypoxia (CIH). In preliminary studies, investigators exposed C57BL/6 mice, that are typically resistant to engraftment of malignant plasma cells to CIH, followed by injection of malignant 5TGM1 cells. With CIH, 5TGM1 cells homed to bone marrow, and engrafted and expanded, resulting in lethal disease. These mice had key features of the myeloma phenotype, including bone damage and gammopathy. Investigators explored potential mechanisms by which CIH promote MM progression by performing whole bone marrow RNASeq analysis. They found pathways relevant to angiogenesis, cell adhesion, and stromal cell development (including dendritic cells and eosinophils) to be upregulated. This is an exciting and potentially translational finding because these elements are also upregulated in the bone marrow of human myeloma patients. Investigators also found upregulation of B cell and plasma cell development and differentiation pathway, and downregulation of B-cell apoptosis pathways. Taking these preliminary findings together, the overarching hypothesis is that CIH increases oxidative stress, thereby supporting B cell maturation and changing the bone marrow stromal microenvironment to drive the progression to MM.
- Being tested
- Bone Marrow Aspirate and Biopsy
- Medical subject headings
- Multiple Myeloma, Monoclonal Gammopathy of Undetermined Significance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone Marrow Aspirate and BiopsyProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| A. patients with MGUS and sleep apnea | Not described Receives: Procedure: Bone Marrow Aspirate and Biopsy | |
| B. patients with MGUS and no sleep apnea | Not described Receives: Procedure: Bone Marrow Aspirate and Biopsy | |
| C. patients with MM and sleep apnea | Not described Receives: Procedure: Bone Marrow Aspirate and Biopsy | |
| D. patients with MM and no sleep apnea | Not described Receives: Procedure: Bone Marrow Aspirate and Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To quantify the incidence of sleep apnea and sleep disorder in patients with MGUS and MM
Measured: 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.
Measured: From study initiation up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2019
- Study start23 May 2019
- Primary completion23 May 2030 (estimated)
- Study completion23 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Michael Tomasson
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor-investigator, Michael Tomasson, University of Iowa
- Investigators
- Michael Tomasson, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04114084
- Sponsor's protocol ID
- 202208637-A
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2019
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Apnea in Patients With MGUS and MM
- ClinicalTrials.gov ID
- NCT04114084
- Acronym / sponsor ID
- 202208637-A
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Michael TomassonUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 23 May 2019 (actual)
- Primary completion
- 23 May 2030 (estimated)
- Study completion
- 23 May 2030 (estimated)
- First posted
- 3 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obesity is a risk factor for the development of MM, although the mechanisms that link obesity and MM are unclear. Obesity, in turn, is closely associated with obstructive sleep apnea. Interestingly, the key risk factors for both sleep apnea and MM are overlapping (age, sex, race and body mass index). During the apnea, or cessation of normal breathing, arterial oxygen saturation falls. This can occur as often as 60 times per hour, resulting in chronic intermittent hypoxia (CIH). In preliminary studies, investigators exposed C57BL/6 mice, that are typically resistant to engraftment of malignant plasma cells to CIH, followed by injection of malignant 5TGM1 cells. With CIH, 5TGM1 cells homed to bone marrow, and engrafted and expanded, resulting in lethal disease. These mice had key features of the myeloma phenotype, including bone damage and gammopathy. Investigators explored potential mechanisms by which CIH promote MM progression by performing whole bone marrow RNASeq analysis. They found pathways relevant to angiogenesis, cell adhesion, and stromal cell development (including dendritic cells and eosinophils) to be upregulated. This is an exciting and potentially translational finding because these elements are also upregulated in the bone marrow of human myeloma patients. Investigators also found upregulation of B cell and plasma cell development and differentiation pathway, and downregulation of B-cell apoptosis pathways. Taking these preliminary findings together, the overarching hypothesis is that CIH increases oxidative stress, thereby supporting B cell maturation and changing the bone marrow stromal microenvironment to drive the progression to MM.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A. patients with MGUS and sleep apnea | – | Procedure: Bone Marrow Aspirate and Biopsy |
| B. patients with MGUS and no sleep apnea | – | Procedure: Bone Marrow Aspirate and Biopsy |
| C. patients with MM and sleep apnea | – | Procedure: Bone Marrow Aspirate and Biopsy |
| D. patients with MM and no sleep apnea | – | Procedure: Bone Marrow Aspirate and Biopsy |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bone Marrow Aspirate and BiopsyThe 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. | Procedure or surgery | 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 |
Primary outcome
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
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 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Tomasson, MD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma and Monoclonal Gammopathy of Undetermined Significance, run by Michael Tomasson at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Tomasson, MD (319-356-4200, michael-tomasson@uiowa.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.