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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

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.

Condition or disease Intervention/treatment
Multiple Myeloma Monoclonal Gammopathy of Undetermined Significance Procedure: Bone Marrow Aspirate and Biopsy

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.

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Apnea in Patients With MGUS and MM
Actual Study Start Date : May 23, 2019
Estimated Primary Completion Date : May 23, 2024
Estimated Study Completion Date : May 23, 2024


Group/Cohort Intervention/treatment
A. patients with MGUS and sleep apnea 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.

B. patients with MGUS and no sleep apnea 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.

C. patients with MM and sleep apnea 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.

D. patients with MM and no sleep apnea 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.




Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Biospecimen Retention:   Samples With DNA
Whole exome, genome wide and RNA sequencing


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04114084


Contacts
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Contact: Melissa Bates, PhD 319-335-7972 melissa-bates@uiowa.edu
Contact: Tina Knutson 319-384-5287 tina-knutson@uiowa.edu

Locations
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United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Melissa Bates, PhD    319-335-7972    melissa-bates@uiowa.edu   
Contact: Tina Knutson    319-384-5287      
Sponsors and Collaborators
Melissa Bates
Department of Health and Human Services
Investigators
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Principal Investigator: Melissa Bates, PhD University of Iowa
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Responsible Party: Melissa Bates, Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT04114084    
Other Study ID Numbers: 201807760-A
First Posted: October 3, 2019    Key Record Dates
Last Update Posted: September 8, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Paraproteinemias
Monoclonal Gammopathy of Undetermined Significance
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Hypergammaglobulinemia