Thalidomide and hematopoietic-cell transplantation for multiple myeloma

摘要: Background High-dose therapy with melphalan can prolong survival among patients multiple myeloma. We assessed whether the addition of thalidomide, which has activity against advanced and refractory myeloma, would further improve survival. Methods Between October 1998 February 2004, 668 newly diagnosed myeloma received two cycles intensive melphalan-based chemotherapy, each supported by autologous hematopoietic stem-cell transplantation. A total 323 were randomly assigned to receive thalidomide from outset until disease progression or undue adverse effects, 345 did not thalidomide. The primary end point was five-year event-free rate. Secondary points complete response overall Results After a median follow-up 42 months survivors, control groups had rates 62 percent 43 percent, respectively (P<0.001), 56 44 (P = 0.01). rate approximately 65 in both 0.90). Median after relapse 1.1 years group 2.7 0.001). Severe peripheral neuropathy deep-vein thrombosis occurred more frequently than group. Conclusions When incorporated into high-dose for increased frequency responses extended at expense added effects without improving (ClinicalTrials.gov number, NCT00083551.)