Table 4 Summary of R2-ISS stage and risk factors considered for R2-ISS staging (patients with early relapse 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 = 93)

Pomalidomide plus dexamethasone (n = 94)

All (N = 187)

Isatuximab plus carfilzomib plus dexamethasone (n = 61)

Carfilzomib plus dexamethasone (n = 46)

All (N = 107)

ISS stage at study entry

      

 Stage I

36 (38.7%)

24 (25.5%)

60 (32.1%)

19 (31.1%)

25 (54.3%)

44 (41.1%)

 Stage II

35 (37.6%)

40 (42.6%)

75 (40.1%)

28 (45.9%)

12 (26.1%)

40 (37.4%)

 Stage III

22 (23.7%)

28 (29.8%)

50 (26.7%)

14 (23.0%)

9 (19.6%)

23 (21.5%)

 Unknown

0

2 (2.1%)

2 (1.1%)

0

0

0

del(17p)a

      

 Present

8 (8.6%)

13 (13.8%)

21 (11.2%)

10 (16.4%)

8 (17.4%)

18 (16.8%)

 Absent

70 (75.3%)

59 (62.8%)

129 (69.0%)

45 (73.8%)

36 (78.3%)

81 (75.7%)

 Unknown or missing

15 (16.1%)

22 (23.4%)

37 (19.8%)

6 (9.8%)

2 (4.3%)

8 (7.5%)

Serum lactate dehydrogenase

      

 ≤Upper limit of normal

63 (67.7%)

57 (60.6%)

120 (64.2%)

43 (70.5%)

35 (76.1%)

78 (72.9%)

 >Upper limit of normal

30 (32.3%)

37 (39.4%)

67 (35.8%)

18 (29.5%)

11 (23.9%)

29 (27.1%)

 Missing

0

0

0

0

0

0

t(4;14)a

      

 Present

9 (9.7%)

10 (10.6%)

19 (10.2%)

7 (11.5%)

11 (23.9%)

18 (16.8%)

 Absent

71 (76.3%)

60 (63.8%)

131 (70.1%)

48 (78.7%)

33 (71.7%)

81 (75.7%)

 Unknown or missing

13 (14.0%)

24 (25.5%)

37 (19.8%)

6 (9.8%)

2 (4.3%)

8 (7.5%)

1q21+b

      

 Present

48 (51.6%)

32 (34.0%)

80 (42.8%)

25 (41.0%)

26 (56.5%)

51 (47.7%)

 Absent

18 (19.4%)

28 (29.8%)

46 (24.6%)

29 (47.5%)

17 (37.0%)

46 (43.0%)

 Unknown or missing

27 (29.0%)

34 (36.2%)

61 (32.6%)

7 (11.5%)

3 (6.5%)

10 (9.3%)

R2-ISS stage

      

 Stage I

6 (6.5%)

5 (5.3%)

11 (5.9%)

5 (8.2%)

5 (10.9%)

10 (9.3%)

 Stage II

12 (12.9%)

12 (12.8%)

24 (12.8%)

15 (24.6%)

12 (26.1%)

27 (25.2%)

 Stage III

36 (38.7%)

30 (31.9%)

66 (35.3%)

27 (44.3%)

21 (45.7%)

48 (44.9%)

 Stage IV

10 (10.8%)

14 (14.9%)

24 (12.8%)

7 (11.5%)

4 (8.7%)

11 (10.3%)

 Not classified

29 (31.2%)

33 (35.1%)

62 (33.2%)

7 (11.5%)

4 (8.7%)

11 (10.3%)

  1. Data are n (%). Early relapse defined as relapse <12 months from initiation of the most recent line of therapy (for patients with ≥2 prior lines of therapy), relapse <18 months for patients with 1 prior line of therapy, or relapse <12 months from autologous stem-cell transplant. Primary refractory patients could not be considered as having early relapse. 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. b1q21+ (cutoff of 30%) was assessed by a central laboratory 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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