Response-adapted intensification with cyclophosphamide, bortezomib, and dexamethasone vs no intensification in patients with newly diagnosed multiple myeloma (Myeloma XI): A multicentre, open-label, randomized, phase 3 trial
The Lancet Haematology Oct 21, 2019
Jackson GH, Davies FE, Pawlyn C, et al. - In the Myeloma XI trial, an open-label, randomized, phase 3, adaptive design trial performed at 110 National Health Service hospitals in the UK, experts evaluated the clinical value of maximizing responses by using therapeutic agents with various modes of action, the use of which is governed by the response to the initial combination therapy and to investigate response-adapted intensification treatment with cyclophosphamide, bortezomib, and dexamethasone vs no intensification treatment in individuals with recently diagnosed multiple myeloma who had a suboptimal response to initial immunomodulatory triplet treatment (n = 583), which was conventional care in the UK at the time of trial design. In comparison with no intensification treatment, in individuals with newly diagnosed multiple myeloma and suboptimal response to immunomodulatory induction therapy, intensification treatment with CVD significantly enhanced progression-free survival, however, it did not improve overall survival. The flexible safety profile of this combination and the encouraging results support the additional examination of response-adapted strategies in this setting. The substantial number of individuals not entering this trial randomization after induction therapy, nonetheless, may encourage the use of combination therapies upfront to maximize response and enhance results as is now the standard of care in the UK.
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