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An event is serious (based on the ICH definition) when the patient outcome is:
* death
* life-threatening
* hospitalisation
* disability
* congenital anomaly
* other medically important event
An 87-year-old man developed bilateral chalazia and blepharitis during treatment with bortezomib for multiple myeloma (MM). Additionally, he exhibited lack of effectiveness during treatment with dexamethasone/oxytetracycline for bilateral chalazia and blepharitis [not all routes and dosages stated].
The man was referred to hospital with MM. First-line therapy consisted of nine cycles of lenalidomide and dexamethasone. A few months after the end of the first-line therapy, disease progression was noted and he was initiated on six cycles of bortezomib 1.3 mg/m2 once weekly (on days 1, 8, 15 and 22) for 6 weeks with concurrent administration of melphalan and prednisone. Serum monoclonal protein was not detectable after two cycles of the therapeutic regimen. During the third cycle, he developed eyelid inflammation. Ophthalmological exam confirmed a diagnosis of right predominant bilateral chalazia and blepharitis attributed to bortezomib therapy [duration of treatment to reaction onset not stated].
The man received treatment with topical application of dexamethasone/oxytetracycline for one month, but was unsuccessful. In order to minimise visits to the hospital during the COVID-19 outbreak, bortezomib was replaced with home medication of oral ixazomib 2.3mg once weekly (on days 1, 8, 15 and 22) combined with unchanged prednisone and melphalan treatment (cycles of six weeks). A reduced dose of ixazomib (off-label use) was administered considering the age. He achieved complete resolution of ocular symptoms within two weeks. Subsequently, the topical treatment was able to be discontinued without relapse of ocular manifestations. Following the ixazomib therapy, the monoclonal protein remained undetectable during three months follow-up period.