Table 1 Patient demographics, baseline disease, and clinical characteristics.

From: Daratumumab, lenalidomide, and dexamethasone in relapsed/refractory myeloma: a cytogenetic subgroup analysis of POLLUX

 

Standard cytogenetic risk*

High cytogenetic risk*,†

Characteristic

D-Rd (n = 193)

Rd (n = 176)

D-Rd (n = 35)

Rd (n = 35)

Age, y

 Median (range)

66 (36–89)

64 (42–85)

67 (50–80)

67 (50–81)

 ≥75 y, n (%)

21 (11)

17 (10)

4 (11)

6 (17)

Sex, n (%)

 Male

114 (59)

102 (58)

19 (54)

19 (54)

Race, n (%)

 White

131 (68)

120 (68)

28 (80)

23 (66)

 Asian

47 (24)

35 (20)

4 (11)

8 (23)

 Black or African American

4 (2)

5 (3)

1 (3)

2 (6)

 Unknown/not reported

11 (6)

16 (9)

2 (6)

2 (6)

ISS stage, n (%)

 I

96 (50)

92 (52)

13 (37)

14 (40)

 II

62 (32)

50 (28)

15 (43)

13 (37)

 III

35 (18)

34 (19)

7 (20)

8 (23)

ECOG performance status score, n (%)

 0

94 (49)

90 (51)

15 (43)

22 (63)

 1

91 (47)

78 (44)

18 (51)

12 (34)

 2

8 (4)

8 (5)

2 (6)

1 (3)

Cytogenetic profile,*,† n (%)

t(4;14)

10 (29)

15 (43)

t(14;16)

2 (6)

6 (17)

 del17p

25 (71)

20 (57)

 ≥2 risk factors§

2 (6)

5 (14)

Median (range) time from diagnosis, y

3.7 (0.6–22.5)

4.0 (0.4–18.3)

3.2 (0.4–27.0)

2.3 (0.4–14.6)

Prior lines of therapy, n (%)

 1

96 (50)

90 (51)

22 (63)

20 (57)

 2

62 (32)

47 (27)

6 (17)

9 (26)

 3

24 (12)

24 (14)

5 (14)

4 (11)

 >3

11 (6)

15 (9)

2 (6)

2 (6)

 Median (range)

2 (1–11)

1 (1–8)

1 (1–6)

1 (1–6)

Prior ASCT, n (%)

115 (60)

115 (65)

22 (63)

19 (54)

Prior PI, n (%)

162 (84)

148 (84)

31 (89)

31 (89)

 Bortezomib

160 (83)

145 (82)

30 (86)

31 (89)

Prior IMiD, n (%)

103 (53)

102 (58)

22 (63)

15 (43)

 Lenalidomide

27 (14)

33 (19)

10 (29)

4 (11)

Prior PI + IMiD, n (%)

79 (41)

80 (46)

18 (51)

12 (34)

Refractory to PI only, n (%)

42 (22)

29 (17)

8 (23)

9 (26)

Refractory to IMiD only, n (%)

7 (4)

10 (6)

3 (9)

1 (3)

Refractory to PI and IMiD, n (%)

6 (3)

7 (4)

1 (3)

3 (9)

Refractory to last line of therapy, n (%)

62 (32)

50 (28)

11 (31)

13 (37)

  1. D-Rd daratumumab plus lenalidomide/dexamethasone, Rd lenalidomide/dexamethasone, ISS International Staging System, ECOG Eastern Cooperative Oncology Group, ASCT autologous stem cell transplant, PI proteasome inhibitor, IMiD immunomodulatory drug, FISH fluorescence in situ hybridization.
  2. Note: percentages may not equal 100% due to rounding.
  3. *Based on FISH/karyotyping.
  4. Patients with high cytogenetic risk had a t(4;14), t(14;16), or del17p abnormality.
  5. ISS stage is derived based on the combination of serum β2-microglobulin and albumin.
  6. §Patients with ≥2 of the t(4;14), t(14;16), or del17p risk factors.