Rajkumar SV et al. – In a trial to compare thalidomide plus dexamethasone (thal/dex) vs placebo plus dexamethasone (placebo/dex) as primary therapy for newly diagnosed multiple myeloma (MM), it was shown that thal/dex results in significantly higher response rates and significantly prolongs time to progression (TTP) compared with dexamethasone alone in pts with newly diagnosed multiple myeloma (MM) Methods
Pts with untreated symptomatic MM were randomized to thal/dex (arm A) or placebo plus dexamethasone (dex) (arm B)
Pts in arm A received oral thalidomide 50 mg daily, escalated to 100 mg on day 15, and to 200 mg from day 1 of cycle 2 (28-day cycles)
Oral dex 40 mg was administered on days 1 through 4, 9 through 12, and 17 through 20 during cycles 1 through 4 and on days 1 through 4 only from cycle 5 onwards
Pts in arm B received placebo and dex, administered as in arm A
Primary endpoint was TTP
Results
470 pts were enrolled: 235 randomly assigned to thal/dex and 235 to placebo/dex
Overall response rate was significantly higher with thal/dex vs placebo/dex
TTP was significantly longer with thal/dex vs placebo/dex
Grade 4 adverse events were more frequent with thal/dex than with placebo/dex
See all
