Study | Arms | N | Doses and schedule | Follow-up (months) | Prior lines | PFS (months) | ORR (%) | ≥CR (%) | OS (months) | >G3 AE (%) |
---|---|---|---|---|---|---|---|---|---|---|
ASPIRE [19] | KRd vs. Rd | 792 | K, 20/27mg/m2 BIW; R, 25 mg PO, days 1 and 21; 28-days cycle/s. | 67.1 | 2 (1-3) | 26.3 vs. 17.6 HR 0,690 | 87.1 vs. 66.7 OR 3.472 | 31.8 vs. 9.3 | 48.3 vs. 40.4 HR 0.794 | 87 vs. 83.3 AH, 6.4 vs. 2.3 CF, 4.3 vs. 2.1 |
ENDEAVOR [11] | Kd vs. Vd | 929 | K, 20/56 g/m2 I IV, BIW, 28-days cycle; V, 1.3mg/m2 SC/IV, BIW 21-days cycle/s. | 12 | 2 (1-3) | 18.7 vs. 9.4 HR 0.533 | 76.9 vs. 62.6 OR 2.032 | 13 vs. 6 | 47.6 vs. 40 HR 0.791 | An, 14 vs. 10 AH, 9 vs. 3 NP, 2 vs. 8 |
IKEMA [50] | IsaKd vs. Kd | 302 | Isa, 10mg/kg QW for 4w, then given Q2W; 28-days cycle/s. | 20.7 | 2 (1-3) | NR vs. 19.15 HR 0.531 | 86.6 vs. 82.9 P 0.19 | 39.7 vs. 27.6 | NA | 76.8 vs. 67.2 |
CANDOR [51] | DKd vs. Kd | 466 | D, 8mg/kg IV, days 1-2 of cycle 1; 16 mg/kg QW, days 8, 15 and 22 first 2 cycles, then Q2W, cycles 3-6 and every Q4W thereafter; 28-days cycle/s. | 17 | 2 (1-3) | NR vs. 15·8 HR 0.63 | 84 vs. 75 OR 1.9 | 29 vs. 10 (MRD, 18 vs. 4) | NA | 82 vs. 74 TP, 24 vs. 16 AH, 18 vs. 13 Inf, 33 vs. 18 CF, 5 vs. 11 |
ARROW [16] | K QW vs. BIW | 478 | K, 20/70mg/m2 QW vs. 20/27mg/m2 BIW; 28-days cycle. | 12.6 / 12 | 2 (46% vs. 64%) 3 (59% vs. 67%) | 11.2 vs. 7.6 HR 0.69 | 62.9 vs. 40.8 OR 2.68 | 7 vs. 2 | NM | 68 vs. 62 CF, 3 vs. 4 |
ARROW2 (NCT03859427) | KRd QW vs. BIW | 460 | K, 20/ 56mg/m2 QW vs. 20/27mg/m2 BIW; 28-days cycle/s. | NM | 1-3 | NAa | NM | NM | NM | NM |
MM 003 [52] | Pd vs. d | 455 | P, 4mg PO, days 1 and 21; 28-days cycle/s. | 10 | >2 (94.5% pts) | 4 vs. 1.9 HR 0.48 | 31 vs. 10 | 1 vs. 0 | 12.7 vs. 8 HR 0.74 | 88.7 vs. 84.7 |
ICARIA-MM [10] | IsaPd vs. Pd | 307 | Pd ± Isa IV 10mg/kg, days 1, 8, 15, and 22 in cycle 1; days 1 and 15 in subsequent cycles; 28-days cycle/s. | 11.6 | ≥2 | 11.53 vs. 6.47 HR 0.596 | 60.4 vs. 35.3 | 5 vs. 1b | NR | 87 vs. 71 NP, 60.5 vs. 31.3 |
APOLLO EMN14 [53] | DPd vs. Pd | 304 | Pd ± D 16 mg/kg IV or 1,8 g SC QW (8 w), BIW (16 w), Q4W thereafter; 28-days cycle/s | 16.9 | >1 | 12.4 vs. 6.9 HR 0.63 | 69 vs. 46 | 25 vs. 4 | NM | 50 vs. 39 NP, 68 vs. 51 PN, 15 vs. 8 |
TOURMALINE-MM1 [15] | IRd vs. Rd | 722 | I, 4mg PO, days 1, 8 and 15, each 28-days cycle. | 15 | 2 (1-3) | 20.6 vs. 14.7 HR 0.74 | 78.3 vs. 71.5 | 12 vs. 7 | NR | 74 vs. 69 |
NCT03143049 | PCd vs. Pd | 120 | Pd ± Cy 400mg days 1, 8, 15 and 22 each 28-days cycle. | NM | >1 | NM | NM | NM | NM | NM |
OPTIMISMM [31] | PVd vs. Vd | 559 | P, 4mg days 1-14 (each 21-days) +/- V, SC 1.3mg/m2 days 1, 4, 8, and 11 (cycles 1-8) and days 1 and 8 (>cycle 9); 21-days cycle/s. | 15.9 | >1 | 11.2 vs. 7.1 HR 0.61 | 82.2 vs. 50 OR 5.02 | 12.5 vs. 3.2 | NR | 57 vs. 42 |
CASTOR [54] | DVd vs. Vd | 498 | D, 16mg/kg IV QW, days 1, 8 and 15 of cycles 1-3; Q3W on day 1 of cycles 4-8, and Q4W thereafter | 40 | 2 (1-10) | 16.7 vs. 7.1 HR 0.31 (1 prior line, 27.0 vs. 7.9 HR 0.22) | 85 vs. 63 | 30 vs. 10 | NR | TP, 46 vs. 33 PN, 10 vs. 10 Inf, 29 vs. 19 Disc, 10 vs. 9 |
POLLUX [12] | DRd vs. Rd | 569 | D, 16mg/kg IV QW days 1, 8, 15 and 22 of cycles 1-2, 8 w and days 1 and 15 of cycles 3 – 6, 16 w and Q4W thereafter; 28-days cycle/s. | 44 | 1 (1-11) | 44.5 vs. 17.5 HR 0.44 (1 prior line, NR vs. 19.6 HR 0.42) | 93 vs. 72 | 57 vs. 23 (MRD, 30.4 vs. 5.3) | NR | NP, 54.1 vs. 39.9 PN, 12 vs. 8.5 NP(F), 6.0 vs. 2.8 |
ELOQUENT-2 [14] | EloRd vs. Rd | 646 | Elo 10mg/kg IV, days 1, 8, 15 and 22 of cycles 1-2 and then on days 1 and 15 >cycle 3; 28-days cycle/s. | 48 | 2 (1-4) | 19.4 vs. 14.9 HR 0.71 (At 4 y, 21 vs. 14; H-risk, 15 vs. 7) | 79 vs. 66 | 11 vs. 11 | 48 vs. 40 | Inf, 33 vs. 26 LP, 79 vs. 49 NP, 36 vs. 45 |
ELOQUENT-3 [55] | EloPd vs Pd | 117 | Elo 10mg/kg days 1, 8, 15, and 22, cycles 1-2 and 20mg/kg on day 1 of each cycle thereafter; 28-days cycle/s. | 9 | 3 (2-8) | 10.3 vs. 4.7 HR 0.54 | 53 vs. 26 | 8 vs. 2 | HR 0.62 | NP, 13 vs. 27 Inf, 13 vs. 22 |
KEYNOTE-183 [56] | PembroPd vs. Pd | 249 | Pembro IV 200mg, Q3W; 28-days cycle/s. | 8c | 4 (2-4) | 5.6 vs. 8.4 | 34 vs. 40 | NM | At 6 m, 82 vs. 90 | NP, 34 vs. 22 An, 17 vs. 13 PN, 14 vs. 13 AEDTH, 11 vs. 2 |