Total Therapy 2 (TT 2) for Newly Diagnosed Patients with Multiple Myeloma (MM): Examination of Dose Effect of Thalidomide (T) among Those Randomized to T.

TT 2 has completed accrual of 668 patients as of February 2004, of whom 323 were randomized to T. All patients received intensive reduction with VAD, DCEP, CAD, DCEP, melphalan-based tandem autotransplants; consolidation chemotherapy with DPACE; and interferon maintenance. T randomization data still blinded. We report, however, on the effect of total cumulative T dosing through induction (n=185; median T dose 26g, range 0 to 100 g), tandem transplants (n=141; median T dose 33 g, range 0 to 160 g) and consolidation therapy (n=69, median T dose 74 g, range 5 to 250 g). No significant differences in T dose distribution according to quartiles at the 3 observation points existed when examined according to age, gender and prognostically potentially relevant features such as cytogenetic abnormalities, CRP, B2M, LDH and albumin. EFS and OS were then compared, according to T dosing quartiles, from first transplant, consolidation and maintenance initiation. T dose effects were not observed for the first two observation times. When considered from initiation of maintenance, there was one event among 31 patients in the 2 upper quartiles of the cumulative T dose compared to 7 of 35 for the 2 lower quartiles (p=.02). We conclude that, among patients randomized to the T arm of TT 2, cumulative dosing does not reveal an effect until after consolidation therapy, probably attesting to the marked efficacy of the cytotoxic components of TT 2. ![Figure][1] Figure [1]: pending:yes