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Venetoclax is a highly selective, powerful oral BCL2 inhibitor that induces multiple myeloma apoptosis.
Venetoclax combined boronitazome and dexamisson showed encouraging clinical efficacy and acceptable safety and tolerance in Phase 1 trials of multiple myeloma.
study was designed to assess the efficacy of Venetoclax combined boronitazome and dexamisson in patients with recurring/reassotic multiple myeloma.
study was a randomized, double-blind, multicenter Phase 3 trial that recruited patients with recurring/refrectable multiple myeloma over the age of 18 to be randomly assigned to the experimental group (Venetoclax combined boronazome and dexemisen) or the placebo group (placebo combined boronitazome and dexamison) at 2:1.
the first eight courses of treatment were in a 21-day model, from the 9th course to 35 days, and continued treatment until the course of the course progressed or there was insulible toxicity, or the patient withdrew from the trial.
indicator of progress-free survival is progress-free survival.
July 19, 2016 - October 31, 2017, a total of 291 patients were randomly divided into two groups (194 in the experimental group and 97 in the placebo group).
the medium follow-up was 18.7 months, the medium progression-free survival was 22.4 months in the experimental group, and 11.5 months in the placebo group (risk ratio of 0.63, p.010).
the most common 3/4 levels of adverse reactions requiring urgent treatment were a decrease in neutral granulocytes (experimental group vs placebo group: 13% vs 7%), anemia (15% vs 15%) and diarrhea (15% vs 11%). In the
group, 93 people (48%) and 48 (50%) had severe treatment-related adverse reactions, respectively, of which 8 (4%) of the experimental group treated the associated fatal infection, while the placebo group did not.
3 deaths (2 deaths from pneumonia and 1 death from sepsis shock) were thought to be treatment-related, and no treatment-related deaths in the placebo group.
in summary, Venetoclax combined boronitazome and dexemisen for recurring/re treatable multiple myeloma can significantly improve patient prognosis.
, the increased risk of death in the experimental group was largely due to increased infection rates, emphasizing the importance of rational screening of patients treated with the program.