Table 2.
Variable | HRs (95% CIs) based on M‐protein data up to the indicated time cutoffs | |||||
---|---|---|---|---|---|---|
Baseline | 1 month | 2 months | 3 months | 6 months | All Data | |
Maximum % reduction of M‐protein, % | ‐ | 1.42 (1.06–1.92) | 1.09 (1.04–1.15) | 1.08 (1.03–1.13) | 1.21 (1.16–1.25) | 1.21 (1.17–1.25) |
Last observed M‐protein change from baseline, % | ‐ | 0.838 (0.63–1.11) | 1.08 (1.04–1.12) | 1.11 (1.08–1.15) | 1.02 (1.01–1.04) | 1.02 (1.01–1.04) |
Rate of M‐protein change, % per week | ‐ | 1.09 (0.92–1.28) | 0.987 (0.927–1.05) | 0.934 (0.874–0.999) | 0.998 (0.945–1.05) | 0.996 (0.943–1.05) |
Time from MM diagnosis to randomized, years | 0.819 (0.764–0.879) | 0.839 (0.785–0.897) | 0.868 (0.813–0.926) | 0.873 (0.817–0.932) | 0.857 (0.801–0.917) | 0.855 (0.799–0.915) |
Number of lytic bone lesions | 1.3 (1.16–1.47) | 1.83 (1.22–2.77) | 2 (1.31–3.05) | 1.87 (1.23–2.85) | 1.8 (1.18–2.74) | 1.82 (1.2–2.77) |
IgG concentration, g/dL | 1.01 (1.01–1.02) | 1.01 (1–1.02) | 1.01 (1–1.02) | 1.01 (1–1.02) | 1.01 (1–1.02) | 1.01 (1–1.02) |
Alkaline phosphatase, IU/L | 1.01 (1–1.01) | 1.04 (1.02–1.08) | 1.04 (1.02–1.08) | 1.04 (1.01–1.07) | 1.04 (1.01–1.07) | 1.04 (1.01–1.07) |
Prior lenalidomide yes vs. no | 2.260 (1.62–1.47) | 1.65 (1.16–2.33) | 1.62 (1.15–2.29) | 1.5 (1.05–2.12) | 1.55 (1.1–2.18) | 1.47 (1.04–2.07) |
Number of prior therapy lines | 1.880 (1.25–2.82) | 1.24 (1.09–1.42) | 1.18 (1.04–1.35) | 1.18 (1.04–1.35) | 1.2 (1.06–1.37) | 1.21 (1.06–1.37) |
ISS, II or III vs. I | 1.600 (1.14–2.40) | 1.36 (0.971–1.92) | 1.43 (1.02–2) | 1.26 (0.893–1.77) | 1.63 (1.15–2.3) | 1.62 (1.15–2.3) |
Prior radiotherapy yes vs. no | 1.510 (1.09–2.1) | 1.25 (0.9–1.74) | 1.29 (0.921–1.8) | 1.13 (0.802–1.58) | 1.3 (0.929–1.83) | 1.28 (0.914–1.8) |
ECOG score, 1 or 2 vs. 0 | 0.950 (0.697–1.29) | 0.954 (0.704–1.29) | 0.985 (0.726–1.34) | 1.1 (0.81–1.5) | 0.927 (0.679–1.27) | 0.923 (0.676–1.26) |
For maximum reduction of M‐protein (%) and last observed M‐protein change from baseline (%), the hazard ratio is associated with each 10‐unit increase.