Table 5 Summary of median PFS of high cytogenetic risk patients with RRMM in randomized, phase 3 trials
Trial name | High cytogenetic risk definition | Arm 1 (n) | Arm 2 (n) | Arm 1 median PFS, months | Arm 2 median PFS, months | Hazard ratio (95% CI); P value |
|---|---|---|---|---|---|---|
CASTOR | t(4;14), t(14;16), or del17p assessed by FISH or karyotyping | D-Vd (40) | Vd (35) | 12.6 | 6.2 | 0.41 (0.21–0.83); 0.0106 |
ENDEAVOR [19] | t(4;14) or t(14;16) in ≥ 10% of screened plasma cells or del17p in ≥ 20% of screened plasma cells assessed by FISH | Kd (97) | Vd (113) | 8.8 | 6.0 | 0.65 (0.45–0.92); 0.0075 |
ASPIRE [20] | t(4;14), t(14;16), or del17p (in ≥ 60% of screened plasma cells) assessed by FISH | KRd (48) | Rd (52) | 23.1 | 13.9 | 0.70 (0.43–1.16); 0.0829 |
PANORAMA-1 [21] | t(4;14), t(14;16), or del17p assessed by FISH | Panobinostat plus Vd | Vd | – | – | 0.47 (0.18–1.25) |