Infections in relapsed myeloma patients treated with isatuximab plus pomalidomide and dexamethasone during the COVID-19 pandemic: Initial results of a UK-wide real-world study

ABSTRACT

Objectives

There are no real-world data describing infection morbidity in relapsed/refractory myeloma (RRMM) patients treated with anti-CD38 isatuximab in combination with pomalidomide and dexamethasone (IsaPomDex). In this UK-wide retrospective study, we set out to evaluate infections experienced by routine care patients who received this novel therapy across 24 cancer centres during the COVID-19 pandemic.

Methods

The primary endpoint was infection morbidity (incidence, grading, hospitalization) as well as infection-related deaths. Secondary outcomes were clinical predictors of increased incidence of any grade (G2–5) and high grade (≥G3) infections.

Results

In a total cohort of 107 patients who received a median (IQR) of 4 cycles (2–8), 23.4% of patients experienced ≥1 any grade (G2–5) infections (total of 31 episodes) and 18.7% of patients experienced ≥1 high grade (≥G3) infections (total of 22 episodes). Median time (IQR) from start of therapy to first episode was 29 days (16–75). Six patients experienced COVID-19 infection, of whom 5 were not vaccinated and 1 was fully vaccinated. The cumulative duration of infection-related hospitalizations was 159 days. The multivariate (MVA) Poisson Regression analysis demonstrated that a higher co-morbidity burden with Charlson Co-morbidity Index (CCI) score ≥4 (incidence rate ratio (IRR) = 3, p = 0.012) and sub-optimal myeloma response less than a partial response (<PR) (p = 0.048) are independent predictors of ≥ G3 infections.

Conclusion

Our study described initial results of infection burden during IsaPomDex treatment. We recommend close monitoring particularly in elderly patients with co-morbidities, the effective use of an-infective prophylaxis, as well as optimal vaccination strategies, to limit infections.

KEYWORDS:

• Infections
• isatuximab
• pomalidomide
• real-world
• myeloma

Acknowledgements

We thank the Clinical Research Network-West Midlands-National Institute for Health Research-UK, for their support in covering article publication charge (APC) for this manuscript.

Disclosure statement

FD (Sanofi: honoraria for education evening for haematologists). SB (Sanofi: honoraria and advisory board). KR (Sanofi: honoraria and advisory board; BMS: research support, honoraria, advisory board, travel support). All other authors have no conflicts of interest to declare.

Ethical approval

The study received NHS service evaluation approval at each participating site.

Data availability statement

All available data relating to this report are presented in the manuscript and the accompanying tables.