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Boronitazome, loramine and dexamison (VRd) are standard treatments for newly diagnosed multiple myeloma.
second-generation protease inhibitor kafezometham and KRd have shown promising results in Phase 2 trials and may further improve efficacy compared to VRd.
this study is intended to assess whether the KRd option is superior to the VRd option for newly diagnosed multiple myeloma patients who do not consider immediate self-stem cell transplantation (ASCT).
trial was a multicenter, open-label Phase 3 randomized controlled trial that recruited newly diagnosed patients over the age of 18 with multiple myeloma who were unsuitable or did not intend to perform ASCT directly, randomly assigned to the KRd or VRd group at 1:1 for 36 weeks of treatment.
end point of the induction phase is the progress-free survival and the overall survival of the maintenance phase.
December 6, 2013 - December 6, 2019, a total of 1,087 patients (542 in the VRd group and 545 in the KRd group) were recruited.
followed for 9 months (IQR 5-23), and at the time of the second interim analysis, the medium progress-free survival periods of the KRd and VRd groups were 34.6 months (95% CI 28.8-37.8) and 34.4 months (30.1-failed; 95% CI 0.83-1.31; p=0.74).
survival of the two groups was not reached.
the most common non-haematological adverse reactions associated with level 3-4 treatment were fatigue (VRd 6% vs KRd 6%), hyperglycemia (4% vs 6%), diarrhea (5% vs 3%), peripheral neuropathy (8% vs vs. 1%), breathing difficulties (2% vs 7%) and thrombosis events (2% vs 5%).
2 and 11 treatment-related deaths were reported in the VRd group and the KRd group, respectively.
the KRd programme failed to extend the progression-free survival of newly diagnosed patients with multiple myeloma and had more toxic side effects than the VRd programme.
VRd triple program remains the standard induction program for newly diagnosed multiple myeloma patients with standard risk and moderate risk, and is the appropriate foundation for the development of a four-drug joint.
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