Baseline characteristics of the high-risk, standard-risk, and expanded high-risk cytogenetics populations
| . | IRd . | Placebo-Rd . | ||||
|---|---|---|---|---|---|---|
| High risk, n = 75 . | Standard risk, n = 199 . | Expanded high risk, n = 155 . | High risk, n = 62 . | Standard risk, n = 216 . | Expanded high risk, n = 154 . | |
| Median age (range), y | 67.0 (45-86) | 67.0 (38-91) | 67.0 (38-91) | 66.0 (45-89) | 66.0 (30-88) | 66.0 (43-89) |
| Male sex | 41 (55) | 120 (60) | 85 (55) | 25 (40) | 127 (59) | 76 (49) |
| White race | 63 (84) | 174 (87) | 136 (88) | 51 (82) | 181 (84) | 125 (81) |
| ISS stage at screening | ||||||
| I or II | 68 (91) | 170 (85) | 136 (88) | 51 (82) | 189 (88) | 131 (85) |
| III | 7 (9) | 29 (15) | 19 (12) | 11 (18) | 27 (13) | 23 (15) |
| Creatinine clearance, mL/min | ||||||
| <30 | 1 (1) | 2 (1) | 2 (1) | 0 | 5 (2) | 1 (<1) |
| 30-50 | 6 (8) | 16 (8) | 8 (5) | 11 (18) | 31 (14) | 21 (14) |
| >50 | 68 (91) | 181 (91) | 145 (95) | 51 (82) | 179 (83) | 132 (86) |
| Lines of prior therapy | ||||||
| 1 | 45 (60) | 111 (56) | 92 (59) | 34 (55) | 124 (57) | 92 (60) |
| 2 or 3 | 30 (40) | 88 (44) | 63 (41) | 28 (45) | 92 (43) | 62 (40) |
| Disease status | ||||||
| Relapsed | 53 (71) | 157 (79) | 116 (75) | 47 (76) | 164 (76) | 110 (71) |
| Refractory | 9 (12) | 21 (11) | 18 (12) | 10 (16) | 24 (11) | 28 (18) |
| Relapsed and refractory | 13 (17) | 20 (10) | 21 (14) | 5 (8) | 28 (13) | 16 (10) |
| Prior therapies | ||||||
| PI-exposed | 57 (76) | 133 (67) | 106 (68) | 49 (79) | 145 (67) | 105 (68) |
| PI-naive | 18 (24) | 66 (33) | 49 (32) | 13 (21) | 71 (33) | 49 (32) |
| Prior lenalidomide | 9 (12) | 28 (14) | 20 (13) | 8 (13) | 20 (9) | 16 (10) |
| Prior thalidomide | 33 (44) | 89 (45) | 76 (49) | 27 (44) | 106 (49) | 72 (47) |
| Thalidomide-refractory | 11 (15) | 17 (9) | 23 (15) | 10 (16) | 30 (14) | 25 (16) |
| Prior SCT | 47 (63) | 115 (58) | 95 (61) | 28 (45) | 120 (56) | 72 (47) |
| . | IRd . | Placebo-Rd . | ||||
|---|---|---|---|---|---|---|
| High risk, n = 75 . | Standard risk, n = 199 . | Expanded high risk, n = 155 . | High risk, n = 62 . | Standard risk, n = 216 . | Expanded high risk, n = 154 . | |
| Median age (range), y | 67.0 (45-86) | 67.0 (38-91) | 67.0 (38-91) | 66.0 (45-89) | 66.0 (30-88) | 66.0 (43-89) |
| Male sex | 41 (55) | 120 (60) | 85 (55) | 25 (40) | 127 (59) | 76 (49) |
| White race | 63 (84) | 174 (87) | 136 (88) | 51 (82) | 181 (84) | 125 (81) |
| ISS stage at screening | ||||||
| I or II | 68 (91) | 170 (85) | 136 (88) | 51 (82) | 189 (88) | 131 (85) |
| III | 7 (9) | 29 (15) | 19 (12) | 11 (18) | 27 (13) | 23 (15) |
| Creatinine clearance, mL/min | ||||||
| <30 | 1 (1) | 2 (1) | 2 (1) | 0 | 5 (2) | 1 (<1) |
| 30-50 | 6 (8) | 16 (8) | 8 (5) | 11 (18) | 31 (14) | 21 (14) |
| >50 | 68 (91) | 181 (91) | 145 (95) | 51 (82) | 179 (83) | 132 (86) |
| Lines of prior therapy | ||||||
| 1 | 45 (60) | 111 (56) | 92 (59) | 34 (55) | 124 (57) | 92 (60) |
| 2 or 3 | 30 (40) | 88 (44) | 63 (41) | 28 (45) | 92 (43) | 62 (40) |
| Disease status | ||||||
| Relapsed | 53 (71) | 157 (79) | 116 (75) | 47 (76) | 164 (76) | 110 (71) |
| Refractory | 9 (12) | 21 (11) | 18 (12) | 10 (16) | 24 (11) | 28 (18) |
| Relapsed and refractory | 13 (17) | 20 (10) | 21 (14) | 5 (8) | 28 (13) | 16 (10) |
| Prior therapies | ||||||
| PI-exposed | 57 (76) | 133 (67) | 106 (68) | 49 (79) | 145 (67) | 105 (68) |
| PI-naive | 18 (24) | 66 (33) | 49 (32) | 13 (21) | 71 (33) | 49 (32) |
| Prior lenalidomide | 9 (12) | 28 (14) | 20 (13) | 8 (13) | 20 (9) | 16 (10) |
| Prior thalidomide | 33 (44) | 89 (45) | 76 (49) | 27 (44) | 106 (49) | 72 (47) |
| Thalidomide-refractory | 11 (15) | 17 (9) | 23 (15) | 10 (16) | 30 (14) | 25 (16) |
| Prior SCT | 47 (63) | 115 (58) | 95 (61) | 28 (45) | 120 (56) | 72 (47) |
Data are n (%) unless otherwise stated.
ISS, International Staging System; PI, proteasome inhibitor; SCT, stem cell transplant.