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Phase II study of thalidomide plus dexamethasone induction followed by tandem melphalan-based autotransplantation and thalidomide-plus-prednisone maintenance for untreated multiple myeloma: a Southwest Oncology Group trial (S0204)
Journal of Clinical Oncology, 06/25/09
Hussein MA et al. - In a study to assess improved survival results reported for the predecessor, phase III trial S9321 by 50%, it was shown that both overall survival (OS) and event-free survival (EFS) were significantly improved with S0204 compared with S9321 when 121 and 363 pts, respectively, were matched on International Staging System (ISS) stage and lactate dehydrogenase (LDH).
Methods- Newly diagnosed pts with multiple myeloma (MM) were eligible for S0204 with thalidomide-dexamethasone (THAL-DEX) induction, tandem melphalan-based tandem transplantation, and THAL-prednisone maintenance.
- Of 143 eligible pts, 142 started induction, 73% completed first transplantation, 58% completed second transplantation, and 56% started maintenance.
- The quantity of stem cells required for 2 transplantations was reached in 88% of 111 pts undergoing collection, 74% of whom completed both transplantations.
- Partial response, very good partial remission, and complete response were documented after 12 mos of maintenance therapy in 87%, 72%, and 22% of pts, respectively.
- During a median follow-up time of 37 mos, 4-yr estimates of EFS and OS were 50% and 64%, respectively.
- Survival outcomes were superior for ISS stage 1 disease, when LDH levels were normal and a second transplantation was applied in a timely fashion.
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VMP (bortezomib, melphalan, and prednisone) is active and well tolerated in newly diagnosed patients with multiple myeloma with moderately impaired renal function, and results in reversal of renal impairment: Cohort analysis of the phase III Vista study
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