Table 5 Summary of patients enrolled in phase 2/3 clinical trials according to previous exposure to bortezomib or lenalidomide or refractoriness to lenalidomide
Study | Regimen | Phase | V-ex (%) | V-ref (%) | R-ex (%) | R-ref (%) | R-ref in 1L n (%) | ORR/CR (%) | ORR/CR R-ref (%) | PFS (months) | PFS R-ex (months) | PFS R- ref (months) | PFS R-ref in 1L (months) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
ENDEAVOR [11] | Kd | 3 | 54 | 4 | 38 | 25 | 32 a | 77/13 | --- | 18.7 | 12.9 | 8.6 | 15.6 a |
CASTOR [72] | DVd | 3 | 65 | 0 | 36 | 24 | ---- | 85/30 | --- | 16.7 | 9.5 | 7.8 vs. 4.9 HR 0.44 | ---- |
OPTIMISMM [31] | PVd | 3 | 72 | 9 | 100 | 71 | 129 (23) b | 82.2/15.7 | ---- | 11.2 | 11.2 | 9.5 | 17.8 b |
CANDOR [51] | DKd | 3 | 92 | 29 | 42 | 33 | ---- | 84/31.8 | ---- | NR vs. 15.8 HR 0.63 | NR vs. 12.1 HR 0.52 | NR vs. 11.1 HR 0.45 | ---- |
MM-014 [156] | DPd | 2 | 78 | -- | 100 | 75 | 70 (62.5) | ---- | ---- | NR | NR | 21.8 | NR |
APOLLO EMN14 [53] c | DPd | 3 | 100 | 47 | 100 | 79 | 16 (11) | 69/25 | 12.4 vs. 6.9 HR 0.63 | NR | 9.9 vs. 6.5 HR 0.66 | --- | |
IKEMA [50] | IsaKd | 3 | 93 | 31 | ---- | 32 | ---- | 86.6/39.7 | ---- | NR HR 0.53 | ---- | NR HR 0.6 | ---- |
EMN011 [157] d | KPd | 2 | 100 | 100 | 100 | 100 | 100 | 87/65 | 87/65 | 18 | 18 | 18 | 18 |
ICARIA-MM [10] | IsaPd | 3 | 100 | 77 | 100 | 94 | ---- | 60.4 | ---- | 11.53 HR 0.59 | ---- | HR 0.5 | ---- |