Introduction: Monoclonal gammopathy of undetermined significance (MGUS) is present in 1-2% of adults older than 50 years. As 1% of patients progress to multiple myeloma (MM) per year, MGUS monitoring has the potential to improve MM outcomes through earlier diagnosis. A variety of monitoring systems have been implemented in the NHS, including hospital, primary care, and nurse-led surveillance. However, most services are inefficient and unsustainable to support population-based monitoring. Here, we setup a risk-adapted monitoring system (OxCOM), in which patients with new incidental MGUS (iMGUS) in Thames Valley were stratified and prospectively monitored.
Methods: Patients with a new iMGUS were captured over a 24-month period (between 4th March 2021 and 3rd March 2023) in an Immunology Laboratory covering a population of 2.5 million people. Patients were risk-stratified daily by an attending immunologist into high-risk [IgG >30g/L or IgA/IgM >10g/L; or free light chain (FLC) ratio outside 0.1-7.0; or CRAB criteria], intermediate-risk [IgG 15-30g/L or IgA/IgM 5-10g/L; or FLC ratio outside 0.3-3.0; or monoclonal IgD/E or FLC; or band present in urine] or low-risk MGUS [IgG < 15g/L or IgA/IgM < 5g/L]. Low-risk patients were advised for 4-12-monthly remote blood monitoring, run by an OxCOM administrator. Intermediate-risk patients were advised for routine review in a non-Consultant-led telephone or face-to-face (F2F) clinic (primarily nurse-led, supported by physician associate or haematology trainee). High-risk patients were advised for urgent F2F review by a Consultant Haematologist.
Results: 1,507 patients had new iMGUS detected over a 24-month period [1,014 low-risk, 290 intermediate-risk and 203 high-risk iMGUS), with median age 76.8 years and median 17 months of follow-up. Of 525 low-risk patients with ≥12-months follow-up, 475 (90%) had attended a further monitoring event. Of 88 intermediate-risk patients attending non-Consultant-led review (56 telephone and 32 F2F), 34 (39%) received further imaging and 10 (11%) had bone marrow biopsy. At last follow-up, 17 (19%) intermediate-risk patients had been moved to OxCOM remote monitoring, 65% had ongoing follow-up and 10 (11%) had been diagnosed with malignancy [2 MM, 3 smouldering MM, 2 Waldenström macroglobulinemia (WM), 2 lymphoma and 1 AL amyloidosis). Of 63 high-risk patients attending urgent Consultant-led F2F review, 41 (65%) had been diagnosed with malignancy (17 MM, 9 smouldering MM, 1 plasmacytoma, 9 WM, 2 lymphoma and 3 AL amyloidosis).
Conclusions: We demonstrate the feasibility of a risk-adapted high-throughput clinical monitoring service for iMGUS. Immunology Laboratory led central oversight by stratifying patients to either OxCOM remote monitoring, routine OxCOM assessment or urgent F2F haematology review. The service therefore establishes a model to enable tailored follow-up and monitoring of iMGUS, which distributes healthcare resource towards higher-risk patients, whilst enabling sustainable monitoring for lower-risk patients.
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