Table.
The TOURMALINE-MM1 Clinical Trial: Ixazomib plus Lenalidomide and Dexamethasone versus Placebo plus Lenalidomide and Dexamethasone
| Efficacy parameter | Ixazomib/lenalidomide/dexamethasone (N = 360) | Placebo/lenalidomide/dexamethasone (N = 362) |
|---|---|---|
| Progression-free survival | ||
| Events, N (%) | 129 (36) | 157 (43) |
| Median, mo | 20.6 (95% CI, 17.0-NE) | 14.7 (95% CI, 12.9–17.6) |
| Hazard ratio | 0.74 (95% CI, 0.59–0.94) | |
| Stratified log-rank P value | .012 | |
| Response rate | ||
| Overall response, % | 78 | 72 |
| Complete response, % | 12 | 7 |
| Very good partial response, % | 36 | 32 |
| Partial response, % | 30 | 33 |
CI indicates confidence interval; NE, not evaluable.
Source: Ninlaro (ixazomib) capsules prescribing information; November 2015.