Professor Ludwig talks to ecancer at ASH 2019 about an interim efficacy analysis of carfilzomib-revlimid-dexamethasone vs. carfilzomib-thalidomide-dexamethasone weekly (after two twice weekly cycles) followed by carfilzomib maintenance versus control in transplant non-eligible patients with newly diagnosed multiple myeloma (NDMM).
Recent data from the ARROW and CHAMPION-1 studies had shown significant activity of once weekly carfilzomib administration. Furthermore, the recent MUK5 and CARF studies show significantly increased PFS with carfilzomib maintenance therapy. The team compared 9 cycles of weekly carfilzomib-revlimid-dexamethasone (KRd) with weekly carfilzomib-thalidomide-dexamethasone (KTd), after 2 cycles of biweekly therapy, followed by a second randomisation to 12 cycles of carfilzomib maintenance or observation only in elderly NDMM.
It was found that once weekly carfilzomib 56mg/m² in combination with either lenalidomide or thalidomide resulted in high response rate and deep responses including MRD negative status in 47.1% of tested elderly patients with NDMM.
Treatment was associated with an acceptable tolerance profile. In a safety evaluation with 66 patients, the most frequent grade 3/4 hematologic adverse events were anemia (4.5%), leukopenia (1.5%), and thrombocytopenia (6.0%). The non-hematologic grade 3/4 AEs were infections (21.2%), cardiac failure, gastrointestinal disorders, and renal impairment (6.0% each), neurologic disorders, hypertension, and rash (3.0% each), and hepatic failure, SPM, VTE, and psychiatric disorders (1.5% each).
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