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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
A 78-year-old woman developed atypical progression of multiple myeloma following off-label use of tocilizumab for SARS-CoV-2 (COVID-19) infection.
The woman, who had hypercalcaemia, anaemia, renal failure and bone lesions in the sacral spine, was hospitalised in February 2019. Subsequently, she was diagnosed with multiple myeloma with bone marrow extensively infiltrated with plasma cells. She had received chemotherapy with daratumumab, bortezomib [velcade], melphalan and prednisone (Dara –VMP protocol). Following the chemotherapy, her disease improved. In July 2020, she was hospitalised due to COVID-19 infection. During hospitalisation (on day 10 of infection), she exhibited inflammatory condition with an increase in inflammatory cytokines and worsening of breathing. Hence, after the healthcare team consultation, she started receiving off-label treatment with tocilizumab [route and dosage not stated] for COVID-19 infection. Her inflammatory and infectious condition improved with tocilizumab therapy. However, after 10 days from the initiation of tocilizumab therapy, she developed multiple rounded nodules on disseminated location. Subsequent nodules biopsy showed plasmacytomae of anaplastic morphological characteristics, with elevated KI67 (80%). A bone marrow biopsy was also performed which showed absence of plasma cell infiltration. Based on clinical investigation, it was concluded that, she had atypical progression of multiple myeloma secondary to tocilizumab therapy [outcome not stated].
Reference
- Bombonatti JF, et al. RECAIDA ATIPICA DE MIELOMA MULTIPLO ASSOCIADA AO USO DE TOCILIZUMABE PARA COVID -19. Hematology, Transfusion and Cell Therapy : Nov 2020. Available from: URL: 10.1016/j.htct.2020.10.458 [Portuguese abstract; summarised from a translation] [DOI]