Table 1 Baseline demographics and disease characteristics of patients enrolled in the C16010 China Continuation Study
Baseline characteristics | Ixazomib-Rd (n = 57) | Placebo-Rd (n = 58) | Overall (n = 115) |
|---|---|---|---|
Median age, years (range) | 61.0 (30–76) | 61.5 (36–80) | 61.0 (30–80) |
Patient age, n (%) | |||
 ≤65 years | 42 (74) | 41 (71) | 83 (72) |
 >65–75 years | 14 (25) | 14 (24) | 28 (24) |
 >75 years | 1 (2) | 3 (5) | 4 (3) |
Male sex, n (%) | 41 (72) | 38 (66) | 79 (69) |
Baseline ECOG performance status, n (%) | |||
 0 | 25 (44) | 26 (45) | 51 (44) |
 1 | 31 (54) | 29 (50) | 60 (52) |
 2 | 1 (2) | 3 (5) | 4 (3) |
MM subtype at study entry, n (%) | |||
 IgG | 29 (51) | 31 (53) | 60 (52) |
 IgA | 11 (19) | 14 (24) | 25 (22) |
 Light chain only | 13 (23) | 8 (14) | 21 (18) |
 Other | 4 (7) | 5 (9) | 9 (8) |
ISS stage at initial diagnosis, n (%) | |||
 I | 11 (19) | 11 (19) | 22 (19) |
 II | 17 (30) | 14 (24) | 31 (27) |
 III | 21 (37) | 21 (36) | 42 (37) |
 Unknown | 8 (14) | 12 (21) | 20 (17) |
ISS stage at study entry, n (%) | |||
 I | 31 (54) | 38 (66) | 69 (60) |
 II | 21 (37) | 16 (28) | 37 (32) |
 III | 5 (9) | 4 (7) | 9 (8) |
Creatinine clearance, mL/min, n (%) | |||
 <30 | 0 | 1 (2) | 1 (<1) |
 30–<60 | 4 (7) | 8 (14) | 12 (10) |
 60–<90 | 28 (49) | 23 (40) | 51 (44) |
 ≥90 | 25 (44) | 26 (45) | 51 (44) |
Median time since initial MM diagnosis, months (range) | 29.5 (3–143) | 28.6 (1–141) | 28.7 (1–143) |
Lines of prior therapy, n (%) | |||
 1 | 25 (44) | 26 (45) | 51 (44) |
 2 | 20 (35) | 24 (41) | 44 (38) |
 3 | 12 (21) | 8 (14) | 20 (17) |
Disease status at study entry, n (%) | |||
 Relapseda | 15 (26) | 13 (22) | 28 (24) |
 Refractoryb | 28 (49) | 33 (57) | 61 (53) |
 Relapsed and refractoryc | 14 (25) | 12 (21) | 26 (23) |
Prior therapy exposure, n (%) | |||
 Prior proteasome inhibitor (all bortezomib) | 34 (60) | 36 (62) | 70 (61) |
 Prior immunomodulatory drug therapy | 52 (91) | 47 (81) | 99 (86) |
  Lenalidomide | 3 (5) | 7 (12) | 10 (9) |
  Thalidomide | 52 (91) | 45 (78) | 97 (84) |
   Thalidomide-refractory | 37 (65) | 35 (60) | 72 (63) |
 Prior corticosteroids | 57 (100) | 58 (100) | 115 (100) |
  Dexamethasone | 56 (98) | 57 (98) | 113 (98) |
  Prednisone | 17 (30) | 20 (34) | 37 (32) |
 Prior melphalan | 24 (42) | 24 (41) | 48 (42) |
 Prior stem cell transplant | 8 (14) | 12 (21) | 20 (17) |