Page 211 - Haematologica Vol. 109 - July 2024

ARTICLE - S-DVd in RRMM patients
neutropenia (50.0% vs. 30.3%; P=0.1) in part 1. Similar rates
of infection were observed, with seven cases with grade 3-4 infection in part 1 and nine in part 2, with two fatal cases occurred in the study (1 patient in each part due to septic shock) (Table 3). Overall, one patient in part 1 dis- continued the treatment due to toxicity (severe cytopenias persisting beyond the cycle 1).
Median number of cycles received in part 1 of the study
V. González-Calle et al.
was 7 (range, 1-47) and 17 (range, 1-27) in part 2. Cumu- lative doses of selinexor, daratumumab, bortezomib and dexamethasone delivered are depicted in Table 4, and no statistically significant differences among these cumula- tive doses administered between part 1 and part 2 of the study were found. Regarding dose modifications, selinexor was the drug most frequently modified and was reduced in 30 (52.7%) patients, (10 dose reductions in part 1 and 20
Table 3. Incidence of most common treatment-related adverse events.
Incidence of AE in the ITT population N=57
Incidence of AE in part 1 N=24
Incidence of AE in part 2 N=33
P
All grade
Grade ≥ 3
All grade
Grade ≥ 3
All grade
Grade ≥ 3
Hematological AE, N (%)
47 (82.4)
34 (59.6)
22 (91.6)
16 (66.7)
25 (75.8)
18 (54.5)
0.1
Thrombocytopenia
40 (70.2)
26 (45.6)
20 (83.3)
13 (54.2)
20 (60.6)
13 (39.4)
0.06
Neutropenia
22 (38.6)
17 (29.8)
12 (50.0)
10 (41.7)
10 (30.3)
7 (21.2)
0.1
Anemia
17 (29.8)
7 (12.3)
8 (33.3)
5 (20.8)
9 (27.3)
2 (6.1)
0.6
Non-Hematological AE, N (%)
Infection
42 (73.6)
18 (31.6)
17 (70.8)
8 (33.3)
25 (75.8)
10 (30.3)
0.9
Asthenia or fatigue
25 (43.9)
8 (14.0)
9 (37.5)
2 (8.3)
16 (48.5)
6 (18.2)
0.4
Diarrhea
22 (38.6)
2 (3.5)
8 (33.3
1 (4.2)
14 (42.4)
1 (3.0)
0.5
Nausea or vomiting
20 (35.1)
5 (8.8)
7 (29.2)
2 (8.3)
13 (39.4)
3 (9.1)
0.4
Peripheral neuropathy
10 (17.5)
0 (0)
3 (12.5)
0 (0)
7 (21.2)
0 (0)
0.4
Loss of apetite
3 (5.3)
0 (0)
2 (8.3)
0 (0)
1 (3.0)
0 (0)
0.4
ITT: intention-to-treat population; AE: adverse events.
Table 4. Cycles, cumulative doses of selinexor, daratumumab, bortezomib and dexamethasone (S-DVd) and dose modifications in GEM Selibordara trial.
Whole series N=57
Part 1 N=24
Part 2 N=33
P
Cycles administered, median (range)
12 (1-47)
7 (1-47)
17 (1 - 27)
0.1
Cumulative doses
Selinexor mg, median (IQR)
2,140 (630-3,860)
1,750 (405-3,950)
2,400 (630-3,850)
0.6
Daratumumab mg, mean (SD)
25,422 (16,847)
22,655 (21,313)
27,434 (12,660)
0.3
Bortezomib mg/m2, mean (SD)
47.1 (33.3)
42.9 (42.5)
50.1 (25.3)
0.5
Dexamethasone mg, median (IQR)
1,600 (540-2,850)
740 (220-2,815)
2,080 (1,020-2,850)
0.1
Dose modifications
Selinexor, N (%)
No dose modification
19 (33.3)
9 (37.5)
10 (30.3)
0.2
Dose reduction
30 (52.7)
10 (41.7)
20 (60.6)
Withdrawn
8 (14.0)
5 (20.8)
3 (9.1)
Daratumumab, N (%)
No dose modification
57 (100)
24 (100)
33 (100)
0.2
Withdrawn
0 (0)
0 (0)
0 (0)
Bortezomib, N (%)
No dose modification
38 (66.7)
16 (66.7)
22 (66.7)
0.3
Dose reduction
15 (26.3)
5 (20.9)
10 (30.3)
Withdrawn
4 (7.0)
3 (12.5)
1 (3)
Dexamethasone, N (%)
No dose modification
45 (78.9)
17 (70.8)
28 (84.8)
0.2
Dose reduction
10 (17.5)
5 (20.8)
5 (15.2)
Withdrawn
2 (3.5)
2 (8.3)
0 (0)
Part 1: weekly selinexor dose 100 mg in 4-week cycles. Part 2: weekly selinexor dose 60 mg in 5-week cycles. IQR: interquartile range. SD: standard deviation.
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