Table 1 Patient and disease characteristics at baseline in the ASPIRE and ENDEAVOR phase 3 studies

From: Efficacy and safety of carfilzomib regimens in multiple myeloma patients relapsing after autologous stem cell transplant: ASPIRE and ENDEAVOR outcomes

 

ASPIRE

ENDEAVOR

 

Prior ASCT

No prior ASCT

Prior ASCT

No prior ASCT

 

KRd (n=217)

Rd (n=229)

KRd (n=179)

Rd (n=167)

Kd (n=266)

Vd (n=272)

Kd (n=198)

Vd (n=193)

Age (years)

 Median (range)

60.0 (38.0–78.0)

62.0 (31.0–80.0)

69.0 (43.0–87.0)

70.0 (41.0–91.0)

61.5 (35.0–79.0)

62.0 (30.0–76.0)

72.0 (39.0–89.0)

71.0 (44.0–88.0)

ECOG PS, n (%)

 0–1

204 (94.0)

218 (95.2)

152 (84.9)

143 (85.6)

256 (96.2)

259 (95.2)

176 (88.9)

176 (91.2)

 2

13 (6.0)

11 (4.8)

27 (15.1)

24 (14.4)

10 (3.8)

13 (4.8)

22 (11.1)

17 (8.8)

ISS stage at baseline among patients with known staging a , n (%)

 I

109 (50.9)

108 (47.8)

58 (33.3)

46 (28.2)

136 (51.1)

143 (52.6)

76 (38.4)

62 (32.1)

 II–III

105 (49.1)

118 (52.2)

116 (66.7)

117 (71.8)

130 (48.9)

129 (47.4)

122 (61.6)

131 (67.9)

Creatinine clearance (ml/min), n (%)

Mean (s.d.)

90.6 (29.7)

92.6 (31.3)

78.1 (26.5)

76.5 (25.9)

84.8 (32.4)

83.3 (32.7)

65.7 (27.4)

63.4 (28.2)

 <30

0

1 (0.4)

0

0

11 (4.1)

12 (4.4)

17 (8.6)

16 (8.3)

 30–<50

5 (2.3)

10 (4.4)

20 (11.2)

21 (12.6)

23 (8.6)

23 (8.5)

34 (17.2)

48 (24.9)

 50–<80

86 (39.6)

73 (31.9)

85 (47.5)

80 (47.9)

91 (34.2)

95 (34.9)

95 (48.0)

82 (42.5)

 ⩾80

126 (58.1)

143 (62.4)

73 (40.8)

62 (37.1)

141 (53.0)

142 (52.2)

52 (26.3)

47 (24.4)

 Missing

0

2 (0.9)

1 (0.6)

4 (2.4)

0

0

0

0

Cytogenetic risk among patients with known status by FISH b , n (%)

 High

31 (29.0)

37 (26.6)

17 (19.3)

15 (18.1)

54 (24.8)

75 (31.6)

43 (26.4)

38 (22.8)

 Standard

76 (71.0)

102 (73.4)

71 (80.7)

68 (81.9)

164 (75.2)

162 (68.4)

120 (73.6)

129 (77.2)

Time to enrollment since first transplant (months)

 Median (range)

33.0 (3.5–203.3)

33.2 (3.6–243.4)

NA

NA

40.2 (2.9–217.4)

37.9 (3.5–193.6)

NA

NA

Prior proteasome inhibitor and IMiD treatment, n (%)

 Bortezomib

155 (71.4)

157 (68.6)

106 (59.2)

103 (61.7)

167 (62.8)

163 (59.9)

83 (41.9)

89 (46.1)

 Lenalidomide

49 (22.6)

40 (17.5)

30 (16.8)

38 (22.8)

106 (39.8)

90 (33.1)

71 (35.9)

87 (45.1)

Duration of prior proteasome inhibitor and IMiD treatment, median months (range)

 Bortezomib

3.8 (0.0–26.2)

3.9 (0.0–32.2)

4.9 (0.9–49.1)

5.6 (0.4–33.6)

4.0 (0.1–38.0)

4.3 (0.3–27.4)

9.0 (1.3–46.0)

7.8 (1.0–33.0)

 Lenalidomide

5.7 (0.5–40.8)

7.7 (0.8–38.0)

11.4 (0.4–40.2)

10.4 (0.3–30.0)

11.0 (0.5–75.8)

9.0 (0.5–77.2)

11.5 (0.8–51.7)

10.9 (0.3–86.0)

  1. Abbreviations: ASCT, autologous stem cell transplantation; ECOG PS, Eastern Cooperative Oncology Group performance status; FISH, fluorescence in situ hybridization; IMiD, immunomodulatory drug; ISS, International Staging System; Kd, carfilzomib+dexamethasone; KRd, carfilzomib+lenalidomide+dexamethasone; NA, not available; Rd, lenalidomide+dexamethasone; Vd, bortezomib+dexamethasone.
  2. aPercentages are calculated as a proportion of the number of patients with known ISS stage. In ASPIRE, 2% of patients had missing ISS stage; in ENDEAVOR, no patients had missing ISS stage.
  3. bPercentages are calculated as a proportion of the number of patients with known cytogenetics. In ASPIRE, 47% of patients had unknown cytogenetics; in ENDEAVOR, 16% of patients had unknown or missing cytogenetics.
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