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Clinical Trial
. 2011 Aug 4;118(5):1231-8.
doi: 10.1182/blood-2011-02-338665. Epub 2011 Jun 7.

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

Gareth J Morgan  1 , Faith E Davies, Walter M Gregory, Nigel H Russell, Sue E Bell, Alexander J Szubert, Nuria Navarro Coy, Gordon Cook, Sylvia Feyler, Jenny L Byrne, Huw Roddie, Claudius Rudin, Mark T Drayson, Roger G Owen, Fiona M Ross, Graham H Jackson, J Anthony Child; NCRI Haematological Oncology Study Group
Collaborators, Affiliations
Clinical Trial

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

Gareth J Morgan et al. Blood. .

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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Figures

Figure 1
Figure 1
Consort diagram of the nonintensive pathway of the MRC Myeloma IX trial.
Figure 2
Figure 2
Survival in patients assigned to the nonintensive pathway based on age, using the optimum age cutoff point (81 years).
Figure 3
Figure 3
Response to MP and CTDa.
Figure 4
Figure 4
Survival according to treatment group with log-rank P value. (A) PFS. (B) OS.
Figure 5
Figure 5
Survival according to treatment group in patients with favorable cytogenetics. (A) PFS. (B) OS.
Figure 6
Figure 6
OS among patients. Influence of (A) treatment response and (B) cytogenetic profile among patients achieving a CR.
See this image and copyright information in PMC

References

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    1. Myeloma Trialists' Collaborative Group. Combination chemotherapy versus melphalan plus prednisone as treatment for multiple myeloma: an overview of 6,633 patients from 27 randomized trials. J Clin Oncol. 1998;16(12):3832–3842. - PubMed
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