Recruiting

Observational Study

Sponsor:

Michael Tomasson

Code:

NCT04114084

Conditions

Multiple Myeloma

Monoclonal Gammopathy of Undetermined Significance

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Bone Marrow Aspirate and Biopsy

Study Details

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.

Conditions

Multiple Myeloma

Monoclonal Gammopathy of Undetermined Significance

Study ID

NCT04114084

Start date

May 23, 2019

Status verified date

Nov, 2025

Completion date

May 23, 2030

Anticipated

Primary completion date

May 23, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Michael Tomasson, MD

319-356-4200michael-tomasson@uiowa.edu

Locations

University of Iowa

Recruiting

Iowa City, Iowa, United States, 52242

Contacts

Michael Tomasson, MD

319-356-4200michael-tomasson@uiowa.edu

More Information

Sponsor

Michael Tomasson

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Michael Tomasson on 2025-11-10.