Skip to main content

Table 4 Patients with improvement, no change, or decline in HRQoL based on minimal clinically important differences defined by an ECOG-based anchor

From: Quality of life analyses in patients with multiple myeloma: results from the Selinexor (KPT-330) Treatment of Refractory Myeloma (STORM) phase 2b study

  

Total FACT-MM; n (%) a

FACT-G; n (%) b

FACT-MM TOI; n (%) c

MM Domain; n (%) d

Max N

Improvement

No change

Decline

Improvement

No change

Decline

Improvement

No change

Decline

Improvement

No change

Decline

Cycle 2

71 e

9 (12.9)

42 (60.0)

19 (27.1)

9 (12.9)

38 (54.3)

23 (32.9)

10 (14.1)

36 (50.7)

25 (35.2)

14 (19.7)

39 (54.9)

18 (25.4)

Cycle 3

42

4 (9.5)

25 (59.5)

13 (31.0)

4 (9.5)

17 (40.5)

21 (50.0)

6 (14.3)

22 (52.4)

14 (33.3)

9 (21.4)

25 (59.5)

8 (19.1)

Cycle 4

25

2 (8.0)

14 (56.0)

9 (36.0)

4 (16.0)

10 (40.0)

11 (44.0)

1 (4.0)

14 (56.0)

10 (40.0)

1 (4.0)

17 (68.0)

7 (28.0)

Cycle 5

13

4 (30.8)

3 (23.1)

6 (46.2)

4 (30.8)

2 (15.4)

7 (53.9)

3 (23.1)

2 (15.4)

8 (61.5)

1 (7.7)

7 (53.9)

5 (38.5)

Cycle 6

8 f

2 (28.6)

2 (28.6)

3 (42.9)

2 (28.6)

2 (28.6)

3 (42.9)

2 (28.6)

2 (28.6)

3 (42.9)

2 (25.0)

5 (62.5)

1 (12.5)

End of treatment

38

3 (7.9)

17 (44.7)

18 (47.4)

3 (7.9)

11 (29.0)

24 (63.2)

3 (7.9)

14 (36.8)

21 (55.3)

10 (25.6)

13 (33.3)

16 (41.0)

  1. FACT-G Functional Assessment of Cancer Therapy – General, FACT-MM Functional Assessment of Cancer Therapy – Multiple Myeloma, MM multiple myeloma, TOI Trial Outcomes Index
  2. a Minimal clinically important difference based on mean difference (13.5 points) in baseline FACT-MM total score between patients with ECOG 0 vs ECOG 1 to 2
  3. b Minimal clinically important difference based on mean difference (7.8 points) in baseline FACT-G score between patients with ECOG 0 vs ECOG 1 to 2
  4. c Minimal clinically important difference based on mean difference (11.0 points) in baseline FACT-MM TOI score between patients with ECOG 0 vs ECOG 1 to 2
  5. d Minimal clinically important difference based on mean difference (5.8) in baseline MM domain score between patients with ECOG 0 vs ECOG 1 to 2
  6. e For FACT-MM and FACT-G, n = 70
  7. f For FACT-MM and FACT-G, n = 7