Table 1 Selected baseline demographics of randomized populations from ICARIA-MM and IKEMA.

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

 

ICARIA-MM

IKEMA

Isatuximab plus pomalidomide plus dexamethasone (n = 154)

Pomalidomide plus dexamethasone (n = 153)

Isatuximab plus carfilzomib plus dexamethasone (n = 179)

Carfilzomib plus dexamethasone (n = 123)

Age (years)

    

 Median

68 (60–74)

66 (59–71)

65 (55–70)

63 (57–70)

 <65

54 (35%)

70 (46%)

88 (49%)

66 (54%)

 ≥65 to <75

68 (44%)

54 (35%)

74 (41%)

47 (38%)

 ≥75

32 (21%)

29 (19%)

17 (9%)

10 (8%)

Gender

    

 Female

65 (42%)

83 (54%)

78 (44%)

55 (45%)

 Male

89 (58%)

70 (46%)

101 (56%)

68 (55%)

eGFRa <60 mL/min per 1.73 m2

55/142 (39%)

49/145 (34%)

43/165 (26%)

18/111 (16%)

Previous autologous stem-cell transplant

83 (54%)

90 (59%)

116 (65%)

69 (56%)

Time from initial diagnosis of multiple myeloma to randomization, years

4.5 (2.6–7.2)

4.1 (2.9–7.0)

3.2 (2.0–5.5)

3.3 (2.1–5.8)

Number of previous lines of therapy

3 (2–4)

3 (2–4)

2 (1–2)

2 (1–3)

Previous therapy

    

 Alkylating agents

139 (90%)

148 (97%)

169 (94%)

101 (82%)

 Proteasome inhibitors

154 (100%)

153 (100%)

166 (93%)

105 (85%)

 Immunomodulatory agents

154 (100%)

153 (100%)

136 (76%)

100 (81%)

 Monoclonal antibodies

0

0

5 (3%)

1 (1%)

Refractory to treatment

    

 Last regimen

150 (97%)

151 (99%)

89 (50%)

73 (59%)

 Immunomodulatory agent

147 (95%)

144 (94%)

78 (44%)

58 (47%)

 Proteasome inhibitor

118 (77%)

115 (75%)

56 (31%)

44 (36%)

 Lenalidomide

144 (94%)

140 (92%)

57 (32%)

42 (34%)

 Lenalidomide in last previous regimen

93 (60%)

88 (58%)

36 (20%)

31 (25%)

  1. Data are n (%), n/N (%), or median (IQR) unless otherwise indicated.
  2. aCalculated using the MDRD equation in patients with race reported in case report form. For ICARIA-MM, patients with creatinine clearance <30 mL/min were excluded; for IKEMA, patients with eGFR <15 mL/min per 1.73 m2 were excluded. eGFR estimated glomerular filtration rate, MDRD modification of diet in renal disease, IQR interquartile range.