Table 1 Summary of safety outcomes by White and Black race.

From: Daratumumab plus lenalidomide maintenance in newly diagnosed multiple myeloma after transplant: AURIGA subgroup analyses

 

D-R

R

 

White (n = 64)

Black (n = 20)

White (n = 65)

Black (n = 24)

Any grade TEAEs, n (%)

63 (98.4)

20 (100)

64 (98.5)

24 (100)

 Most commona

  Neutropeniab

40 (62.5)

14 (70.0)

41 (63.1)

16 (66.7)

  Diarrhea

39 (60.9)

12 (60.0)

40 (61.5)

11 (45.8)

  Fatigue

31 (48.4)

8 (40.0)

29 (44.6)

12 (50.0)

  URTI

26 (40.6)

9 (45.0)

18 (27.7)

5 (20.8)

  Arthralgia

23 (35.9)

4 (20.0)

24 (36.9)

10 (41.7)

  Cough

21 (32.8)

10 (50.0)

20 (30.8)

12 (50.0)

  Hypokalemia

21 (32.8)

9 (45.0)

19 (29.2)

15 (62.5)

  Back pain

20 (31.3)

7 (35.0)

12 (18.5)

4 (16.7)

  Thrombocytopenia

17 (26.6)

3 (15.0)

22 (33.8)

4 (16.7)

  Nausea

16 (25.0)

8 (40.0)

18 (27.7)

8 (33.3)

  Leukopenia

16 (25.0)

6 (30.0)

16 (24.6)

11 (45.8)

  Rash maculo-papular

14 (21.9)

6 (30.0)

15 (23.1)

2 (8.3)

  Anemia

12 (18.8)

8 (40.0)

11 (16.9)

6 (25.0)

Grade 3/4 TEAEs, n (%)

49 (76.6)

15 (75.0)

46 (70.8)

16 (66.7)

 Most commonc

  Neutropeniab

29 (45.3)

10 (50.0)

28 (43.1)

11 (45.8)

  Lymphopenia

9 (14.1)

0

5 (7.7)

0

  Hypokalemia

6 (9.4)

1 (5.0)

3 (4.6)

3 (12.5)

  Leukopenia

5 (7.8)

3 (15.0)

4 (6.2)

2 (8.3)

  Diarrhea

2 (3.1)

1 (5.0)

2 (3.1)

3 (12.5)

  Fatigue

0

2 (10.0)

2 (3.1)

1 (4.2)

Grade 3/4 cytopenias, n (%)

35 (54.7)

10 (50.0)

31 (47.7)

12 (50.0)

Grade 3/4 infections, n (%)

13 (20.3)

4 (20.0)

8 (12.3)

5 (20.8)

COVID-19 events, n (%)

 Any grade

18 (28.1)

7 (35.0)

20 (30.8)

5 (20.8)

 Grade 3/4

1 (1.6)

0

1 (1.5)

2 (8.3)

Serious TEAEs, n (%)

20 (31.3)

6 (30.0)

14 (21.5)

7 (29.2)

 Most commond

  Pneumonia

4 (6.3)

0

3 (4.6)

1 (4.2)

TEAEs leading to discontinuation of any treatment component,e n (%)

14 (21.9)

0

7 (10.8)

1 (4.2)

Death due to TEAEs, n (%)

2 (3.1)

0

1 (1.5)

0

  1. D-R daratumumab/lenalidomide, R lenalidomide, TEAE treatment-emergent adverse event, URTI upper respiratory tract infection.
  2. aDefined as ≥30% of patients in either treatment group or racial subgroup.
  3. bPreferred term grouping.
  4. cDefined as ≥10% of patients in either treatment group or racial subgroup.
  5. dDefined as occurring in ≥3 patients in either treatment group or racial subgroup.
  6. eIncludes patients who had TEAEs with an action of “drug withdrawn” taken for ≥1 component of study treatment on the “adverse event” complete report form page.
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