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Table 1 Baseline demographics and disease characteristics of patients enrolled in the C16010 China Continuation Study

From: Randomized, double-blind, placebo-controlled phase III study of ixazomib plus lenalidomide-dexamethasone in patients with relapsed/refractory multiple myeloma: 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)
  1. Abbreviations: ECOG Eastern Cooperative Oncology Group, ISS International Staging System, MM multiple myeloma
  2. aPatients who had relapsed from at least one previous treatment but were not refractory to any previous treatment
  3. bPatients who were refractory to at least one previous treatment but were not relapsed to any previous treatment
  4. 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
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Journal of Hematology & Oncology

ISSN: 1756-8722

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