Patient characteristics and demographics based on prior treatment
| . | Prior IMiD . | Prior BTZ + IMiD . | ≥2 prior regimens including BTZ and an IMiD . | |||
|---|---|---|---|---|---|---|
| PAN-BTZ-Dex (n = 245) . | Pbo-BTZ-Dex (n = 240) . | PAN-BTZ-Dex (n = 94) . | Pbo-BTZ-Dex (n = 99) . | PAN-BTZ-Dex (n = 73) . | Pbo-BTZ-Dex (n = 74) . | |
| Age, median (range), y | 62 (28-82) | 62 (32-81) | 60 (28-79) | 61 (32-77) | 61 (33-79) | 61 (32-77) |
| Time since diagnosis, median (range), mo | 37.7 (4.4-308.1) | 39.9 (2.4-174.9) | 45.1 (8.7-308.1) | 40.2 (11.9-164.8) | 52.9 (10.3-308.1) | 46.3 (11.9-164.8) |
| Sex, n (%) | ||||||
| Male | 125 (51) | 130 (54) | 52 (55) | 49 (49) | 41 (56) | 33 (45) |
| Female | 120 (49) | 110 (46) | 42 (45) | 50 (51) | 32 (44) | 41 (55) |
| ECOG performance status, n (%) | ||||||
| 0 | 121 (49) | 96 (40) | 56 (60) | 38 (38) | 41 (56) | 26 (35) |
| ≥1 | 124 (51) | 144 (60) | 38 (40) | 58 (59) | 32 (44) | 45 (61) |
| ISS stage, n (%) | ||||||
| I | 106 (43) | 99 (41) | 40 (43) | 35 (35) | 31 (43) | 25 (34) |
| II | 60 (25) | 55 (23) | 21 (22) | 19 (19) | 17 (23) | 15 (20) |
| III | 46 (19) | 51 (21) | 19 (20) | 24 (24) | 15 (21) | 19 (26) |
| Not assessed | 33 (14) | 35 (15) | 14 (15) | 21 (21) | 10 (14) | 15 (20) |
| Renal function, n (%) | ||||||
| CCr ≥90 mL/min | 80 (33) | 82 (34) | 35 (37) | 34 (34) | 26 (36) | 25 (34) |
| CCr ≥60-90 mL/min | 164 (67) | 156 (65) | 59 (63) | 63 (64) | 47 (64) | 48 (65) |
| Missing | 1 (0.4) | 2 (1) | 0 | 2 (2) | 0 | 1 (1) |
| MM disease characteristics, n (%) | ||||||
| Relapsed | 127 (52) | 118 (49) | 48 (51) | 44 (44) | 39 (53) | 30 (41) |
| Relapsed and refractory | 115 (47) | 119 (50) | 46 (49) | 53 (54) | 34 (47) | 43 (58) |
| Prior lines of therapy, median (range), n | 2 (1-4) | 2 (1-3) | 2 (1-4) | 2 (1-3) | 3 (2-4) | 3 (2-3) |
| Prior ASCT, n (%) | 140 (57) | 140 (58) | 68 (72) | 69 (70) | 54 (74) | 47 (64) |
| Prior therapies, n (%) | ||||||
| Bortezomib | 94 (38) | 99 (41) | 94 (100) | 99 (100) | 73 (100) | 74 (100) |
| Lenalidomide | 72 (29) | 85 (35) | 34 (36) | 45 (46) | 28 (38) | 37 (50) |
| Thalidomide | 205 (84) | 188 (78) | 78 (83) | 69 (70) | 63 (86) | 50 (68) |
| Bortezomib + lenalidomide | 34 (14) | 45 (19) | 34 (36) | 45 (46) | 28 (38) | 37 (50) |
| Bortezomib + dexamethasone | 89 (36) | 94 (39) | 89 (95) | 94 (95) | 69 (95) | 74 (100) |
| . | Prior IMiD . | Prior BTZ + IMiD . | ≥2 prior regimens including BTZ and an IMiD . | |||
|---|---|---|---|---|---|---|
| PAN-BTZ-Dex (n = 245) . | Pbo-BTZ-Dex (n = 240) . | PAN-BTZ-Dex (n = 94) . | Pbo-BTZ-Dex (n = 99) . | PAN-BTZ-Dex (n = 73) . | Pbo-BTZ-Dex (n = 74) . | |
| Age, median (range), y | 62 (28-82) | 62 (32-81) | 60 (28-79) | 61 (32-77) | 61 (33-79) | 61 (32-77) |
| Time since diagnosis, median (range), mo | 37.7 (4.4-308.1) | 39.9 (2.4-174.9) | 45.1 (8.7-308.1) | 40.2 (11.9-164.8) | 52.9 (10.3-308.1) | 46.3 (11.9-164.8) |
| Sex, n (%) | ||||||
| Male | 125 (51) | 130 (54) | 52 (55) | 49 (49) | 41 (56) | 33 (45) |
| Female | 120 (49) | 110 (46) | 42 (45) | 50 (51) | 32 (44) | 41 (55) |
| ECOG performance status, n (%) | ||||||
| 0 | 121 (49) | 96 (40) | 56 (60) | 38 (38) | 41 (56) | 26 (35) |
| ≥1 | 124 (51) | 144 (60) | 38 (40) | 58 (59) | 32 (44) | 45 (61) |
| ISS stage, n (%) | ||||||
| I | 106 (43) | 99 (41) | 40 (43) | 35 (35) | 31 (43) | 25 (34) |
| II | 60 (25) | 55 (23) | 21 (22) | 19 (19) | 17 (23) | 15 (20) |
| III | 46 (19) | 51 (21) | 19 (20) | 24 (24) | 15 (21) | 19 (26) |
| Not assessed | 33 (14) | 35 (15) | 14 (15) | 21 (21) | 10 (14) | 15 (20) |
| Renal function, n (%) | ||||||
| CCr ≥90 mL/min | 80 (33) | 82 (34) | 35 (37) | 34 (34) | 26 (36) | 25 (34) |
| CCr ≥60-90 mL/min | 164 (67) | 156 (65) | 59 (63) | 63 (64) | 47 (64) | 48 (65) |
| Missing | 1 (0.4) | 2 (1) | 0 | 2 (2) | 0 | 1 (1) |
| MM disease characteristics, n (%) | ||||||
| Relapsed | 127 (52) | 118 (49) | 48 (51) | 44 (44) | 39 (53) | 30 (41) |
| Relapsed and refractory | 115 (47) | 119 (50) | 46 (49) | 53 (54) | 34 (47) | 43 (58) |
| Prior lines of therapy, median (range), n | 2 (1-4) | 2 (1-3) | 2 (1-4) | 2 (1-3) | 3 (2-4) | 3 (2-3) |
| Prior ASCT, n (%) | 140 (57) | 140 (58) | 68 (72) | 69 (70) | 54 (74) | 47 (64) |
| Prior therapies, n (%) | ||||||
| Bortezomib | 94 (38) | 99 (41) | 94 (100) | 99 (100) | 73 (100) | 74 (100) |
| Lenalidomide | 72 (29) | 85 (35) | 34 (36) | 45 (46) | 28 (38) | 37 (50) |
| Thalidomide | 205 (84) | 188 (78) | 78 (83) | 69 (70) | 63 (86) | 50 (68) |
| Bortezomib + lenalidomide | 34 (14) | 45 (19) | 34 (36) | 45 (46) | 28 (38) | 37 (50) |
| Bortezomib + dexamethasone | 89 (36) | 94 (39) | 89 (95) | 94 (95) | 69 (95) | 74 (100) |
ASCT, autologous stem cell transplant; CCr, creatinine clearance rate; ISS, International Staging System.