Table 2 R2-ISS stage and risk factors considered for R2-ISS staging (patients from ICARIA and IKEMA).

From: Allocation and validation of the second revision of the International Staging System in the ICARIA-MM and IKEMA studies

 

ICARIA

IKEMA

Isatuximab plus pomalidomide plus dexamethasone (n = 154)

Pomalidomide plus dexamethasone (n = 153)

All (N = 307)

Isatuximab plus carfilzomib plus dexamethasone (n = 179)

Carfilzomib plus dexamethasone (n = 123)

All (N = 302)

ISS stage at study entry

      

 Stage I

62 (40.3%)

51 (33.3%)

113 (36.8%)

89 (49.7%)

71 (57.7%)

160 (53.0%)

 Stage II

55 (35.7%)

56 (36.6%)

111 (36.2%)

63 (35.2%)

31 (25.2%)

94 (31.1%)

 Stage III

34 (22.1%)

43 (28.1%)

77 (25.1%)

26 (14.5%)

20 (16.3%)

46 (15.2%)

 Unknown

3 (1.9%)

3 (2.0%)

6 (2.0%)

1 (0.6%)

1 (0.8%)

2 (0.7%)

del(17p)a

      

 Present

14 (9.1%)

23 (15.0%)

37 (12.1%)

18 (10.1%)

16 (13.0%)

34 (11.3%)

 Absent

118 (76.6%)

95 (62.1%)

213 (69.4%)

143 (79.9%)

96 (78.0%)

239 (79.1%)

 Unknown or missing

22 (14.3%)

35 (22.9%)

57 (18.6%)

18 (10.1%)

11 (8.9%)

29 (9.6%)

Serum lactate dehydrogenaseb

      

 ≤Upper limit of normal

106 (68.8%)

102 (66.7%)

208 (67.8%)

137 (76.5%)

97 (79.5%)

234 (77.7%)

 >Upper limit of normal

48 (31.2%)

51 (33.3%)

99 (32.2%)

42 (23.5%)

25 (20.5%)

67 (22.3%)

 Missing

0

0

0

0

1 (<0.1%)

1 (<0.1%)

t(4;14)a

      

 Present

12 (7.8%)

14 (9.2%)

26 (8.5%)

22 (12.3%)

20 (16.3%)

42 (13.9%)

 Absent

119 (77.3%)

101 (66.0%)

220 (71.7%)

137 (76.5%)

89 (72.4%)

226 (74.8%)

 Unknown or missing

23 (14.9%)

38 (24.8%)

61 (19.9%)

20 (11.2%)

14 (11.4%)

34 (11.3%)

1q21+c

      

 Present

76 (49.4%)

52 (34.0%)

128 (41.7%)

75 (41.9%)

52 (42.3%)

127 (42.1%)

 Absent

38 (24.7%)

46 (30.1%)

84 (27.4%)

84 (46.9%)

55 (44.7%)

139 (46.0%)

 Unknown or missing

40 (26.0%)

55 (35.9%)

95 (30.9%)

20 (11.2%)

16 (13.0%)

36 (11.9%)

R2-ISS stage

      

 Stage I

11 (7.1%)

9 (5.9%)

20 (6.5%)

31 (17.3%)

17 (13.8%)

48 (15.9%)

 Stage II

27 (17.5%)

24 (15.7%)

51 (16.6%)

47 (26.3%)

38 (30.9%)

85 (28.1%)

 Stage III

52 (33.8%)

47 (30.7%)

99 (32.2%)

68 (38.0%)

37 (30.1%)

105 (34.8%)

 Stage IV

16 (10.4%)

18 (11.8%)

34 (11.1%)

11 (6.1%)

10 (8.1%)

21 (7.0%)

 Not classified

48 (31.2%)

55 (35.9%)

103 (33.6%)

22 (12.3%)

21 (17.1%)

43 (14.2%)

  1. Data are n (%). adel(17p) and t(4;14) were assessed during screening for ICARIA-MM and IKEMA by a central laboratory with a cutoff of 50% and 30%, respectively. bLactate dehydrogenase assessment at baseline for IKEMA: isatuximab–carfilzomib–dexamethasone (n = 179); carfilzomib–dexamethasone (n = 122); all (N = 301). c1q21+ (cutoff of 30%) was assessed by a central laboratory prospectively during screening for IKEMA and retrospectively for ICARIA-MM. ISS International Staging System, R2-ISS Second Revision of the International Staging System.
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