Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation

GJ Morgan, FE Davies, WM Gregory… - Blood, The Journal …, 2011 - ashpublications.org
GJ Morgan, FE Davies, WM Gregory, NH Russell, SE Bell, AJ Szubert, NN Coy, G Cook
Blood, The Journal of the American Society of Hematology, 2011ashpublications.org
As part of the randomized MRC Myeloma IX trial, we compared an attenuated regimen of
cyclophosphamide, thalidomide, and dexamethasone (CTDa; n= 426) with melphalan and
prednisolone (MP; n= 423) in patients with newly diagnosed multiple myeloma ineligible for
autologous stem-cell transplantation. The primary endpoints were overall response rate,
progression-free survival, and overall survival (OS). The overall response rate was
significantly higher with CTDa than MP (63.8% vs 32.6%; P<. 0001), primarily because of …
Abstract
As part of the randomized MRC Myeloma IX trial, we compared an attenuated regimen of cyclophosphamide, thalidomide, and dexamethasone (CTDa; n = 426) with melphalan and prednisolone (MP; n = 423) in patients with newly diagnosed multiple myeloma ineligible for autologous stem-cell transplantation. The primary endpoints were overall response rate, progression-free survival, and overall survival (OS). The overall response rate was significantly higher with CTDa than MP (63.8% vs 32.6%; P < .0001), primarily because of increases in the rate of complete responses (13.1% vs 2.4%) and very good partial responses (16.9% vs 1.7%). Progression-free survival and OS were similar between groups. In this population, OS correlated with the depth of response (P < .0001) and favorable interphase fluorescence in situ hybridization profile (P < .001). CTDa was associated with higher rates of thromboembolic events, constipation, infection, and neuropathy than MP. In elderly patients with newly diagnosed multiple myeloma (median age, 73 years), CTDa produced higher response rates than MP but was not associated with improved survival outcomes. We highlight the importance of cytogenetic profiling at diagnosis and effective management of adverse events. This trial was registered at International Standard Randomized Controlled Trials Number as #68454111.
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