Observational study of patients with monoclonal gammopathy of undetermined significance
A Prospective Long-term Observational Study in Patients With Monoclonal Gammopathy of Undetermined Significance
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 |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Oxford University Hospitals NHS Trust Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT05539079 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 50 and over with a confirmed or suspected diagnosis of MGUS.
Not a fit: Patients under 18 years old or those without evidence of MGUS will not benefit from this study.
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 performed: While there have been studies on MGUS, this observational approach focusing on long-term outcomes is relatively novel.
Eligibility criteria
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 this trial is running
Oxford, Oxfordshire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.