Table 1

Analysis of factors associated with PFS in the intent-to-treat population (N = 482)

VariableTotal patients evaluableMedian PFS, mo (range)Relative risk (95% CI)P
Univariate analysis     
    Hemoglobin, < 10 g/dL 480 30.9 (25.5-not reached) 1.2 (0.9-1.5) .2088 
    t(4;14) and/or del(17p) 482 26.4 (20.2-36.0) 1.5 (1.0-2.2) .0313 
    Best response to therapy less than VGPR 482 27.9 (23.6-33.2) 1.7 (1.1-2.6) .009 
    β 2-microglobulin > 3 mg/L 482 29.7 (24.4-33.5) 1.7 (1.3-2.2) .0001 
    ISS stage 1 vs 2 and 3 468 28.8 (24.4-33.2) 1.8 (1.4-2.4) <.0001 
    Response induction less than VGPR 482 29.0 (26.4-33.5) 2.2 (1.5-3.0) <.0001 
Multivariate analysis     
    t(4;14) and/or del(17p)   1.5 (1.0-2.1) .0621 
    ISS stage 1 vs 2 and 3   1.8 (1.4-2.4) <.0001 
    Best response to therapy less than VGPR   2.0 (1.5-2.7) <.0001 
    Response to induction less than VGPR   2.3 (1.6-3.2) <.0001 
VariableTotal patients evaluableMedian PFS, mo (range)Relative risk (95% CI)P
Univariate analysis     
    Hemoglobin, < 10 g/dL 480 30.9 (25.5-not reached) 1.2 (0.9-1.5) .2088 
    t(4;14) and/or del(17p) 482 26.4 (20.2-36.0) 1.5 (1.0-2.2) .0313 
    Best response to therapy less than VGPR 482 27.9 (23.6-33.2) 1.7 (1.1-2.6) .009 
    β 2-microglobulin > 3 mg/L 482 29.7 (24.4-33.5) 1.7 (1.3-2.2) .0001 
    ISS stage 1 vs 2 and 3 468 28.8 (24.4-33.2) 1.8 (1.4-2.4) <.0001 
    Response induction less than VGPR 482 29.0 (26.4-33.5) 2.2 (1.5-3.0) <.0001 
Multivariate analysis     
    t(4;14) and/or del(17p)   1.5 (1.0-2.1) .0621 
    ISS stage 1 vs 2 and 3   1.8 (1.4-2.4) <.0001 
    Best response to therapy less than VGPR   2.0 (1.5-2.7) <.0001 
    Response to induction less than VGPR   2.3 (1.6-3.2) <.0001 

ISS indicates International Staging System; PFS, progression-free survival; and VGPR, very good partial response.

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