Oncology Medical News about Thalidomide, Dexamethasone, Prednisone, Multiple myeloma

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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, 07/20/09

Hussein MA et al. – Study reports that both overall survival and event-free survival were significantly improved with S0204 compared with S9321 when 121 and 363 patients with newly diagnosed multiple myeloma (MM), were matched on International Staging System (ISS) stage and lactate dehydrogenase (LDH).

Methods

Phase II trial S0204 designed to improve survival results reported for the predecessor, phase III trial S9321 by 50%
Newly diagnosed pts with MM were eligible for:
- S0204 with thalidomide-dexamethasone (THAL-DEX) induction
- Tandem melphalan-based tandem transplantation, and
- THAL-prednisone maintenance

Results

Of 143 eligible pts, 142 started induction:
- 73% completed first transplantation
- 58% completed second transplantation, and
- 56% started maintenance
Quantity of stem cells required for 2 transplantations was reached in 88% of 111 pts undergoing collection, 74% of whom completed both transplantations
PR, very good partial remission, and CR were documented after 12 mo of maintenance therapy in 87%, 72%, and 22% of pts, respectively
During a median f/u time of 37 mo, 4-yr estimates of event-free 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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