Observational study of patients with monoclonal gammopathy of undetermined significance
Official title: A Prospective Long-term Observational Study in Patients With Monoclonal Gammopathy of Undetermined Significance
Run by Oxford University Hospitals NHS Trust · NCT05539079 · Data updated 2026-11-12
This study is tracking patients with monoclonal gammopathy of undetermined significance to see how the condition changes over time and to find ways to catch and treat multiple myeloma earlier.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 2000 (estimated) |
| Sponsor | Oxford University Hospitals NHS Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oxford, Oxfordshire) |
| Status | Recruiting |
| Started | September 6, 2023 |
| Main results expected | December 1, 2030 |
| Study ends | December 1, 2032 |
| Registry record updated | August 5, 2026 |
| Trial ID | NCT05539079 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals aged 50 and over with a confirmed or suspected diagnosis of MGUS.
✕Probably not a fit
Patients under 18 years old or those without evidence of MGUS will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to monitor patients diagnosed with monoclonal gammopathy of undetermined significance (MGUS) to better understand its progression and complications. MGUS is a precursor condition to multiple myeloma, which affects a significant number of older adults. The study will collect data on patients' health status, diagnostic delays, and any clinical complications that arise, with the goal of improving early detection and management of myeloma. By following patients over time, researchers hope to identify patterns that could lead to better outcomes.
Why it matters
Potential benefit: If successful, this study could lead to earlier diagnosis and improved management of multiple myeloma, enhancing patient survival rates.
How similar studies have gone: While there have been studies on MGUS, this observational approach focusing on long-term outcomes is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: • Any individual with a confirmed or suspected case of MGUS Exclusion Criteria: * Those who are unable or unwilling to give informed consent * Patients under the age of 18 * Patients with no evidence of MGUS * Patients with a light chain ratio of 0.3 to 3.0 without a monoclonal protein on serum electrophoresis or immunofixation * Patients with rapidly rising paraprotein or serum free light chains of progressive disease at time of diagnosis or inclusion into study
Where it's running
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Secure Study
Oxford, Oxfordshire, United Kingdom Recruiting
Study contacts
- Principal investigator: Karthik Ramasamy — Oxford University Hospitals NHS Trust
- Study coordinator: Richard Brouwer, BSc
- Email: richard.brouwer@ouh.nhs.uk
- Phone: 07594301699
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How N-glycosylation of light chains affects AL amyloidosis diagnosis and treatment
This project will test whether a sugar modification called N-glycosylation on immunoglobulin light chains helps cause disease or changes how AL amyloidosis and related monoclonal gammopathies behave in adults.
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Investigating gut microbiota and immune function in monoclonal gammopathy patients
This study looks at the gut bacteria and immune system in patients with monoclonal gammopathy to see how they might be affected, especially in those with infections.
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Collection and analysis of biological samples from patients with multiple myeloma and related conditions
This study is collecting and storing blood samples from patients with multiple myeloma and similar conditions to help researchers learn more about these diseases and improve treatments.
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Multi-omics profiling to predict progression from MGUS and smoldering myeloma to symptomatic multiple myeloma
This project will try to see if combined genomic, immune, and oral microbiome tests can predict which people with MGUS or smoldering myeloma will progress to symptomatic multiple myeloma.
-
Analyzing gut microbiota in patients with monoclonal gammopathy
This study is trying to see how the gut bacteria of people with monoclonal gammopathy differ from those without the condition to help find new ways to diagnose and treat it.
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Identifying precancerous multiple myeloma in African American adults
This study is testing a way to find early signs of multiple myeloma in Black and African American adults aged 30 and older to help catch it sooner and improve their health outcomes.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.