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

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

0006-4971
1231-1238
Morgan, G. J.
2eacfa78-f9fd-4216-9c50-04a3809ecd9e
Davies, F. E.
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Gregory, W. M.
400ff6c9-b53c-4dc9-afe8-2d8217f096d8
Russell, N. H.
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Bell, S. E.
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Szubert, A. J.
fe597ba3-f415-482a-a314-76145fbbe7ea
Coy, N. N.
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Cook, G.
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Feyler, S.
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Byrne, J. L.
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Roddie, H.
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Rudin, C.
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Drayson, M. T.
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Owen, R. G.
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Ross, F. M.
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Jackson, G. H.
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Child, J. A.
9ca05a85-6e86-40b0-83e7-2c2afe5c20f5
Morgan, G. J.
2eacfa78-f9fd-4216-9c50-04a3809ecd9e
Davies, F. E.
b8c3d043-0c0c-4386-a5a7-be0ce86f71a4
Gregory, W. M.
400ff6c9-b53c-4dc9-afe8-2d8217f096d8
Russell, N. H.
5b5fea25-023b-4bb4-a3d8-97c407d2223a
Bell, S. E.
3011934e-cbca-4fa2-8377-a9a758bb4340
Szubert, A. J.
fe597ba3-f415-482a-a314-76145fbbe7ea
Coy, N. N.
851ee23e-09a4-402a-aee6-cf860193dab9
Cook, G.
fbf121a4-8973-4033-8759-81f517347b6e
Feyler, S.
d19dec36-2ecd-4f98-a3d5-523e40c1cacc
Byrne, J. L.
ecdfc0dc-4f7f-4d69-86ea-36fddebaaf8a
Roddie, H.
3fbb2a32-ed2f-449c-9fde-1dbbb88c03c2
Rudin, C.
9041e62b-450d-4455-95aa-302f98d11c5c
Drayson, M. T.
24a45661-4fb4-4063-b918-c519ac4f06ec
Owen, R. G.
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Ross, F. M.
ec0958f8-b992-4e4a-b7e3-c474600390ba
Jackson, G. H.
1ab0aa1e-13d5-4725-a436-753d7d137970
Child, J. A.
9ca05a85-6e86-40b0-83e7-2c2afe5c20f5

Morgan, G. J., Davies, F. E., Gregory, W. M., Russell, N. H., Bell, S. E., Szubert, A. J., Coy, N. N., Cook, G., Feyler, S., Byrne, J. L., Roddie, H., Rudin, C., Drayson, M. T., Owen, R. G., Ross, F. M., Jackson, G. H. and Child, J. A. (2011) Cyclophosphamide, thalidomide, and dexamethasone (CTD) as initial therapy for patients with multiple myeloma unsuitable for autologous transplantation. Blood, 118 (5), 1231-1238. (doi:10.1182/blood-2011-02-338665).

Record type: Article

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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Published date: 4 August 2011
Organisations: Human Development & Health

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Local EPrints ID: 337721
URI: http://eprints.soton.ac.uk/id/eprint/337721
ISSN: 0006-4971
PURE UUID: 375fff89-80b9-4280-8eec-a233cbeb9438

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Date deposited: 02 May 2012 14:38
Last modified: 14 Mar 2024 10:57

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Contributors

Author: G. J. Morgan
Author: F. E. Davies
Author: W. M. Gregory
Author: N. H. Russell
Author: S. E. Bell
Author: A. J. Szubert
Author: N. N. Coy
Author: G. Cook
Author: S. Feyler
Author: J. L. Byrne
Author: H. Roddie
Author: C. Rudin
Author: M. T. Drayson
Author: R. G. Owen
Author: F. M. Ross
Author: G. H. Jackson
Author: J. A. Child

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