| Chronic Leukaemia | ||
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In multiple myeloma, high dose melphalan with autologous stem cell support increases survival but the vast majority of the patients relapse. Besides alkylating agents and steroids, two new drugs are active to treat myeloma: thalidomide and bortezomib (Velcade). There is a need for new treatment and the myeloma community is currently testing new drug combinations. The EBMT is sponsoring a randomized, prospective, international study comparing two regimens to treat myeloma patients relapsing after autologous transplantation: Velcade + Thalidomide + Dexamethasone versus Thalidomide + Dexamethasone. Patients are treated during one year and followed for one more year. The accrual is planned to be 360 patients at 30 centres. The total duration of the study is 4 years. The primary objective is to compare the time to progression between the two groups and the secondary endpoint to evaluate the toxicity mostly neurological. Preliminary studies, in this setting or as an upfront treatment strategy, have shown for both regimens high response rates with acceptable toxicity. Moreover, they are mainly non myelotoxic regimens given to outpatients. Four interim analyses are planned with a regularly update in the EBMT newsletter. D. Niederwieser,
G. Gahrton, L. Garderet |
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