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) |
Abbreviations: ECOG Eastern Cooperative Oncology Group, ISS International Staging System, MM multiple myeloma
aPatients who had relapsed from at least one previous treatment but were not refractory to any previous treatment
bPatients who were refractory to at least one previous treatment but were not relapsed to any previous treatment
cPatients who were relapsed from at least one previous treatment and additionally were refractory to at least one previous treatment. Refractory disease was defined as disease progression on treatment or progression within 60 days after the last dose of a given therapy