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Sleep Apnea in Patients With MGUS and MM

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ClinicalTrials.gov Identifier: NCT04114084
Recruitment Status : Recruiting
First Posted : October 3, 2019
Last Update Posted : September 8, 2022
Sponsor:
Collaborator:
Department of Health and Human Services
Information provided by (Responsible Party):
Melissa Bates, University of Iowa

Tracking Information
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
 (submitted: October 1, 2019)
  • 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 ]
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
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole exome, genome wide and RNA sequencing
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
  • Multiple Myeloma
  • Monoclonal Gammopathy of Undetermined Significance
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.
Study Groups/Cohorts
  • A. patients with MGUS and sleep apnea
    Intervention: Procedure: Bone Marrow Aspirate and Biopsy
  • B. patients with MGUS and no sleep apnea
    Intervention: Procedure: Bone Marrow Aspirate and Biopsy
  • C. patients with MM and sleep apnea
    Intervention: Procedure: Bone Marrow Aspirate and Biopsy
  • D. patients with MM and no sleep apnea
    Intervention: Procedure: Bone Marrow Aspirate and Biopsy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 1, 2019)
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
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Melissa Bates, PhD 319-335-7972 melissa-bates@uiowa.edu
Contact: Tina Knutson 319-384-5287 tina-knutson@uiowa.edu
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
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
Principal Investigator: Melissa Bates, PhD University of Iowa
PRS Account University of Iowa
Verification Date September 2022