TY - JOUR
T1 - Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation
AU - Morgan, GJ
AU - Davies, FE
AU - Gregory, WM
AU - Russell, NH
AU - Bell, SE
AU - Szubert, AJ
AU - Coy, NN
AU - Cook, G
AU - Feyler, S
AU - Byrne, JL
AU - Roddie, H
AU - Rudin, C
AU - Drayson, Mark
AU - Owen, RG
AU - Ross, FM
AU - Jackson, GH
AU - Child, JA
PY - 2011/8/1
Y1 - 2011/8/1
N2 - 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. (Blood. 2011;118(5):1231-1238)
AB - 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. (Blood. 2011;118(5):1231-1238)
U2 - 10.1182/blood-2011-02-338665
DO - 10.1182/blood-2011-02-338665
M3 - Article
C2 - 21652683
SN - 1528-0020
VL - 118
SP - 1231
EP - 1238
JO - Blood
JF - Blood
IS - 5
ER -