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R. Wester et al.
Safety
Any grade hematologic toxicity occurred in 15% of patients. Grade 3/4 hematologic toxicity occurred in 10% of patients. At dose level 27 mg/m2, 36 mg/m2, 45 mg/m2 and 56 mg/m2, grade 3/4 hematologic toxicity occurred in
12%, 10%, 10% and 10%, respectively. Main grade 3/4 non-hematologic toxicity consisted of infections, respira- tory disorders, skin and vascular disorders in 11%, 8%, 9%, and 9%, respectively. There was a gradual increase in grade 3/4 infections from lower to higher doses of carfil-
Table 1. Baseline characteristics. Characteristic
Patients, n
Male, n (%)
Age, median (range), years
20/27 mg/m2
50
34 (68) 58 (29-66)
20/36 mg/m2
20
11 (55) 58 (47-64)
20/45 mg/m2
21
16 (76) 56 (33-65)
20/56 mg/m2
20
7 (35) 58 (37-65)
All patients
111
68 (61) 58 (29-66)
ISS stage, n (%)
1 18(36)
2 20(40)
3 12(24)
Unknown 0(0) 0(0) 1(5) 0(0) 1(1)
R-ISS stage, n (%)
1 7(14) 3(15) 10(48) 6(30) 26(23) 2 37 (74) 10 (50) 7 (33) 11 (55) 65 (59) 3 2(4) 5(25) 0(0) 3(15) 10(9)
5(25) 14(67) 7(35) 4(19) 8(40) 2(10)
9(45) 7(35) 4(20)
46(41) 38(34) 26(23)
Unknown
WHO performance status, n (%) 0
4 (8)
24 (48)
2 (10) 4 (19)
2(10) 0(0) 0(0) 6(5)
7 (35) 11 (52) 10(50) 7(33)
0 (0)
12 (60) 8(40)
10 (9)
54 (49)
1
2 2(4) 1(5) 1(5) 0(0) 4(4) 3 0(0) 0(0) 2(10) 0(0) 2(2)
20(40)
Unknown 4(8)
45(41)
M-protein isotype, n (%)
IgA 11 (22)
IgG 30 (60)
IgD 1(2) 1(5) 1(5) 0(0) 3(3)
Light-chain disease 7 (14) Unknown 1(2)
Genetic abnormalities, n (%)*
add 1q
Yes 5(10) No 35 (70) Unknown 10 (20)
4 (20) 6 (29) 5 (25) 22 (20) 2(10) 0(0) 0(0) 3(3)
5 (25) 4 (19) 4 (20) 24 (22) 8 (40) 10 (48) 11 (55) 59 (53)
4(20) 2(10) 12 (60) 15 (71) 4 (20) 4 (19)
7(35) 10 (50) 3 (15)
18(16) 72 (65) 21 (19)
t(4;14)(p16;32)
Yes 2(4) 2(10) 0(0) 3(15) 7(6) No 39 (78) 14 (70) 19 (90) 13 (65) 85 (77) Unknown 9 (18) 4 (20) 2 (10) 4 (20) 19 (17)
del(17p13)
Yes 3(6) 2(10) 1(5) 1(5) 7(6)
No 38 (76)
Unknown 9 (18)
t(11;14)(q13;q32)
Yes 5(10) No 36 (72) Unknown 9 (18)
14 (70) 18 (86)
4 (20) 2 (10)
1(5) 2(10) 15 (75) 17 (81) 4 (20) 2 (10)
16 (80) 86 (77)
3 (15) 18 (16)
1(5) 9(8) 15 (75) 83 (75) 4 (20) 19 (17)
t(14;16)(q32;q23)
Yes 3(6) 1(5) 0(0) 0(0) 4(4)
No
Unknown
Risk status, n (%)† High
Standard Unknown
38 (76)
9 (18)
19 (38) 21 (42) 10 (20)
15 (75)
4 (20)
10 (50) 6 (30) 4 (20)
19 (90)
2 (10)
4 (19) 12 (57) 5 (24)
16 (80)
4 (20)
10 (50) 7 (35) 3 (15)
88 (79)
19 (17)
43 (39) 46 (41) 22 (20)
Grade1/2PN,n(%)‡ 3(6) 2(10) 0(0) 2(10) 7(7)
PNP,polyneuropathy.*A total of 93 patients were evaluable.The table shows the presence of the genetic abnormality in all four dose levels together and in each dose level sep- arately. †High-risk: t(4;14) and/or 17p- and/or add1q cytogenetic abnormalities and/or ISS stage 3 disease. Standard risk: the remaining patients with available cytogenetics and ISS stage. ‡Not recorded in 9 patients. Ktd: carfilzomib, thalidomide and dexamethasone; n: number: HDM + ASCT: high-dose melphalan + autologous stem cell transplantation. n: number; ISS: International Staging System; R-ISS: Revised International Staging System; WHO: World Health Organisation; PN: polyneuropathy.
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haematologica | 2019; 104(11)