Table 3 Ocular AEs (Part 1 by cohort and RP2D), summary of belamaf dosing (Part 1 by cohort and RP2D) and summary of pomalidomide dosing (Part 1 by cohort and RP2D)

From: Belantamab mafodotin, pomalidomide and dexamethasone in refractory multiple myeloma: a phase 1/2 trial

AEs, maximum grade

1.92 mg kg−1 Q4W

2.5 mg kg−1 Q4W

2.5 mg kg−1 Q8W

2.5 mg kg−1 Q12W

2.5 mg kg−1 LOADINGa

2.5 mg kg−1 SPLIT

RP2D

 

n = 12

n = 7

n = 12

n = 12

n = 5

n = 8

n = 38

Keratopathy, grade 2, n (%)

2 (16.7)

0 (0.0)

3 (25.0)

1 (8.3)

1 (20.0)

1 (12.5)

4 (10.5)

Keratopathy, grade 3–4, n (%)

4 (33.3)

7 (100.0)

7 (58.3)

7 (58.3)

2 (40.0)

5 (62.5)

20 (52.6)

Keratopathy recovery from grade ≥2 to grade 1, n/N (%)

5/6 (83.3)

5/7 (71.4)

6/10 (60.0)

7/8 (87.5)

1/3 (33.3)

5/6 (83.3)

13/24 (54.2)

Decrease in BCVA, grade 2, n (%)

4 (33.3)

2 (28.6)

1 (8.3)

3 (25.0)

1 (20.0)

1 (12.5)

9 (23.7)

Decrease in BCVA, grade 3–4, n (%)

5 (41.7)

5 (71.4)

11 (91.7)

7 (58.3)

4 (80.0)

4 (50.0)

21 (55.3)

BCVA recovery from grade ≥2 to grade 1, n/N (%)

7/9 (77.8)

7/7 (100.0)

4/12 (33.3)

7/10 (70.0)

3/5 (60.0)

5/5 (100.0)

15/30 (50.0)

Blurred vision (patient reported), grade 2, n (%)

2 (16.7)

3 (42.9)

0 (0.0)

1 (8.3)

0 (0.0)

1 (12.5)

2 (5.3)

Blurred vision (patient reported), grade 3–4, n (%)

1 (8.3)

1 (14.3)

2 (16.7)

1 (8.3)

0 (0.0)

1 (12.5)

5 (13.2)

Other ocular toxicity, grade 2, n (%)

1 (8.3)

1 (14.3)

0 (0.0)

1 (8.3)

1 (20.0)

2 (25.0)

4 (10.5)

Other ocular toxicity, grade 3–4, n (%)

0 (0.0)

1 (14.3)

0 (0.0)

1 (8.3)

0 (0.0)

0 (0.0)

0 (0.0)

Belamaf dosing

1.92 mg kg−1 SINGLE

2.5 mg kg−1 Q4W

2.5 mg kg−1 Q8W

2.5 mg kg−1 Q12W

2.5 mg kg−1 LOADINGa

2.5 mg kg−1 SPLIT

RP2D

 

n = 12

n = 7

n = 12

n = 12

n = 5

n = 8

n = 38

No. of cycles administered, median (range)

14 (2–32)

27 (13–36)

19 (7–30)

13 (1–30)

9 (6–37)

23 (3–45)

15 (1–30)

No. of expected doses, median (range)

14 (2–32)

27 (13–36)

10 (4–15)

5 (1–10)

9 (6–37)

23 (3–45)

8 (1–15)

No. of doses administered, median (range)

7 (2–20)

8 (5–14)

6 (2–11)

3 (1–7)

7 (2–25)

9 (2–19)

4 (1–11)

No. of doses missed, median (range)

3 (0–22)

14 (7–28)

4 (0–9)

2 (0–4)

5 (2–27)

15 (1–26)

3 (0–9)

Intended dose intensity (mg kg−1 Q4W)

1.92

2.5

1.25

0.83

2.5a

2.5

1.25

Actual dose intensity (mg kg−1 Q4W), median (range)

1.7 (0.5–1.9)

0.5 (0.5–1.1)

0.5 (0.2–0.9)

0.3 (0.1–0.8)

0.7 (0.5–1.6)

0.6 (0.2–1.7)

0.5 (0.1–1.3)

Relative dose intensity (%), median (range)

88 (29–100)

22 (19–43)

41 (16–75)

36 (15–100)

29 (20–62)

50 (14–100)

37 (11–100)

Pomalidomide dosing

1.92 mg kg−1 SINGLE

2.5 mg kg−1 Q4W

2.5 mg kg−1 Q8W

2.5 mg kg−1 Q12W

2.5 mg kg−1 LOADINGa

2.5 mg kg−1 SPLIT

RP2D

 

n = 12

n = 7

n = 12

n = 12

n = 5

n = 8

n = 38

Patients with ≥1 dose reduction, n (%)

7 (58.3)

5 (71.4)

6 (50.0)

6 (50.0)

3 (60.0)

5 (62.5)

12 (31.6)

No. of doses missed, median (range)

0 (0–1)

0 (0–3)

0 (0–1)

0 (0–0)

0 (0–1)

0 (0–1)

0 (0–1)

Intended dose intensity (mg Q4W)

84

84

84

84

84

84

84

Actual dose intensity (mg Q4W), median (range)

84.0 (57.0–86.0)

83.3 (52.6–84.7)

84.0 (54.7–84.0)

81.8 (58.4–84.2)

83.4 (75.8–84.0)

83.4 (50.1–84.0)

84.0 (54.7–86.0)

Relative dose intensity (%), median (range)

100 (70–100)

100 (60–100)

100 (70–100)

100 (70–100)

100 (90–100)

100 (60–100)

100 (70–100)

  1. Keratopathy and BCVA graded per the KVA scale; blurred vision and other ocular toxicity are from CTCAE v.5.0.
  2. Data on the 3.4 mg kg−1 SPLIT group are in Extended Data Table 3a.
  3. aLoading dose is 2.5 mg kg−1 Q4W then reduced to 1.92 mg kg−1 Q4W.
  4. Data on the 3.4 mg kg−1 SPLIT group are in Extended Data Table 3b.
  5. Data on the 3.4 mg kg−1 SPLIT group are in Extended Data Table 3c.
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