Toxicity
A summary of the toxicities associated with this protocol are included in the table below. The most clinically significant toxicities for this treatment are peripheral neuropathy and haematological adverse events. During induction, peripheral neuropathy was reported in 38% of patients and was grade 3/4 in 3.9% using RVd in the PETHEMA/GEM2012 study. Haematological grade 3/4 events were common in patients, including neutropenia (12.9%) and thrombocytopenia (6.3%).r
During induction, 14 patients (3.1%) had one or more treatment-emergent adverse event (TEAE) leading to discontinuation (cardiac disorders [1.1%] and infections [0.9%]), and 9 patients (2%) died due to TEAEs. Dose modifications were reported for bortezomib (32.1%), lenalidomide (26.4%) and dexamethasone (11.4%). The most common TEAEs leading to dose reduction or interruption of bortezomib was peripheral neuropathy and, for lenalidomide, were neutropenia and skin toxicity.r
During consolidation, the most common haematological TEAEs during consolidation were neutropenia (grade 3/4 10.5%) and thrombocytopenia (grade 3/4 9.9%), and the most common non-haematological TEAE was peripheral neuropathy (7.6% all grades, grade 3/4 0.3%). Dose modifications were reported for bortezomib (26.6%), lenalidomide (18.2%) and dexamethasone (6.8%).r
Table 1 - Adverse events through inductionr
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