What is the clinical evidence from this study?

Study design: Cohort. Population: Monoclonal Gammopathy of Undetermined Significance (MGUS) (n=1133). Intervention: Incidentally detected MGUS. Primary outcome: Progression from MGUS to multiple myeloma (MM).

What does this research mean for the field?

In a UK prospective cohort of 1,133 patients with incidentally detected Monoclonal Gammopathy of Undetermined Significance (MGUS), 10 participants have progressed to multiple myeloma during the baseline period. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

What question did this study set out to answer?

To establish a real-world prospective reference for the epidemiology, diagnostic pathways, and baseline progression risk among individuals with incidentally detected MGUS in the UK.

July 23, 2026Blood Cancer JournalOpen Access

SECURE study: baseline findings from a UK prospective cohort of incidentally detected MGUS

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Key result

Incidentally detected MGUS progresses to multiple myeloma in ~1% of patients in baseline cohort analysis.

n=1,133

Key Points

To establish a real-world prospective reference for the epidemiology, diagnostic pathways, and baseline progression risk among individuals with incidentally detected MGUS in the UK.
Prospective, multicentre, non-interventional observational cohort study across 35 NHS sites in the UK, evaluating adults (≥18 years) with confirmed MGUS by IMWG criteria.
Analyzed an interim cohort of N=1133 participants (from 1244 recruited toward a planned sample size of 2000, with follow-up up to 60 months per participant) using clinical records, biospecimens, and patient-reported outcomes.
Route to diagnosis was available for 1083 participants, comprising 77.0% identified via secondary care and 22.3% via primary care; median age was 71 years (range 25–95) and 53.0% were male.
Among participants who underwent risk stratification, 30.2% were classified as low, 44.8% as low-intermediate, 23.2% as high-intermediate, and 1.8% as high risk for progression.
Baseline progression risk factors among tested participants were an abnormal free light-chain ratio (52.4%), non-IgG isotype (29.9%), and monoclonal protein ≥15 g/L (14.2%).

Study Design

Type

Cohort (n=1,133)

Multicenter

Yes

Structured PICO

Population

1,133 adults with incidentally detected monoclonal gammopathy of undetermined significance (MGUS) followed prospectively for up to 60 months.

Outcome

Progression from MGUS to multiple myeloma (MM)hard clinical

The SECURE study provides a real-world baseline characterization of incidentally detected MGUS in the UK, highlighting that the majority of patients are diagnosed in secondary care and fall into low or low-intermediate risk categories for progression.

Limitations

Missing data expected under standard-of-care practice
Clinically detected cohort mostly from secondary care, not directly comparable with screened populations
Ethnicity and other subgroup analyses are currently underpowered
Short follow-up with few progression events
Lack of an MGUS-negative comparator group
448 patients had missing risk factor data (majority paraprotein concentration) and therefore could not be risk stratified

Discussion

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Implication

Early progression appears low in this MGUS cohort; leaves open optimal long-term surveillance and risk models.

Cite This Study

Knight et al. (2026) conducted a cohort in Monoclonal Gammopathy of Undetermined Significance (MGUS) (n=1,133). Incidentally detected MGUS was evaluated on Progression from MGUS to multiple myeloma (MM). In the baseline analysis of the UK SECURE prospective cohort of 1,133 patients with incidentally detected MGUS, 10 participants have progressed to multiple myeloma to date.

synapsesocial.com/papers/6a61ae6bfaa9903c51169c19 https://doi.org/10.1038/s41408-026-01576-x

View Full Paper

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Bookmark

SECURE study: baseline findings from a UK prospective cohort of incidentally detected MGUS

Key Points

Study Design

Structured PICO

Limitations

Discussion

Implication

Cite This Study

SECURE study: baseline findings from a UK prospective cohort of incidentally detected MGUS

Key Points

Study Design

Structured PICO

Limitations

Discussion

Implication

Cite This Study

Also Consider

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