Table 4

Response rates (ORR, ITT, IRC-based), PFS, and OS in subgroups with adverse prognosis (N = 84)

PFS (mo)OS (mo)
PatientsNORR, N (%)Median (95%CI)/% at 1 yMedian (95%CI)/% at 1 y
ITT 84 29 (34.5) 4.6 (4, 7)/25.5 14.9 (11, 20)/57 
Refractory to lenalidomide 75 27 (36) 4.2 (3, 6)/23 13.9 (9, 18)/54.5 
Refractory to lenalidomide as last line * 26 6 (23) 4.4 (2, 9)/22 19.2 (9, —)/63 
Refractory to bortezomib 68 20 (29) 3.8 (3, 6)/24 13.8 (9, 18)/54 
Refractory to last line * 71 23 (32) 3.9 (3, 7)/25 13.9 (8.5, 19)/55 
Double refractory 64 20 (31) 3.8 (3, 5)/24 13.8 (9, 16)/53 
More than 6 lines of therapy* 19 4 (21) 3.2 (2, 5)/16 9.2 (3, —)/47 
Del17p and/or t(4;14) 21 6 (27) 2.6 (2, 4)/5 5.4 (3, 9)/33 
PFS (mo)OS (mo)
PatientsNORR, N (%)Median (95%CI)/% at 1 yMedian (95%CI)/% at 1 y
ITT 84 29 (34.5) 4.6 (4, 7)/25.5 14.9 (11, 20)/57 
Refractory to lenalidomide 75 27 (36) 4.2 (3, 6)/23 13.9 (9, 18)/54.5 
Refractory to lenalidomide as last line * 26 6 (23) 4.4 (2, 9)/22 19.2 (9, —)/63 
Refractory to bortezomib 68 20 (29) 3.8 (3, 6)/24 13.8 (9, 18)/54 
Refractory to last line * 71 23 (32) 3.9 (3, 7)/25 13.9 (8.5, 19)/55 
Double refractory 64 20 (31) 3.8 (3, 5)/24 13.8 (9, 16)/53 
More than 6 lines of therapy* 19 4 (21) 3.2 (2, 5)/16 9.2 (3, —)/47 
Del17p and/or t(4;14) 21 6 (27) 2.6 (2, 4)/5 5.4 (3, 9)/33 
*

Before entry into IFM 2009-02

Double refractory, refractory to bortezomib and lenalidomide. ORR ≥PR.

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