Sleep Apnea in Patients With MGUS and MM
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| ClinicalTrials.gov Identifier: NCT04114084 |
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Recruitment Status :
Recruiting
First Posted : October 3, 2019
Last Update Posted : September 8, 2022
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Sponsor:
Melissa Bates
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Melissa Bates, University of Iowa
| Tracking Information | |||||||||
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| First Submitted Date | October 1, 2019 | ||||||||
| First Posted Date | October 3, 2019 | ||||||||
| Last Update Posted Date | September 8, 2022 | ||||||||
| Actual Study Start Date | May 23, 2019 | ||||||||
| Estimated Primary Completion Date | May 23, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Sleep Apnea in Patients With MGUS and MM | ||||||||
| Official Title | Sleep Apnea in Patients With MGUS and MM | ||||||||
| 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. | ||||||||
| 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 Type | Observational | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description: Whole exome, genome wide and RNA sequencing
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| Sampling Method | Non-Probability Sample | ||||||||
| 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 | ||||||||
| Condition |
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| Intervention | Procedure: Bone Marrow Aspirate and Biopsy
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.
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
200 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | May 23, 2024 | ||||||||
| Estimated Primary Completion Date | May 23, 2024 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria | 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 | ||||||||
| Sex/Gender |
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| Ages | 18 Years to 99 Years (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04114084 | ||||||||
| Other Study ID Numbers | 201807760-A | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Current Responsible Party | Melissa Bates, University of Iowa | ||||||||
| Original Responsible Party | Same as current | ||||||||
| Current Study Sponsor | Melissa Bates | ||||||||
| Original Study Sponsor | Same as current | ||||||||
| Collaborators | Department of Health and Human Services | ||||||||
| Investigators |
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| PRS Account | University of Iowa | ||||||||
| Verification Date | September 2022 | ||||||||