Table 2 Primary outcomes sFLC response to two cycles of therapy, renal response to 4 cycles of therapy, and Quality of Life (EQ-5D-3L index and EQ VAS scores) by treatment arm.

From: Bortezomib, Bendamustine and Dexamethasone vs Thalidomide, Bendamustine and Dexamethasone in Myeloma patients presenting with renal failure (OPTIMAL): a randomised, multi-centre phase II trial

Outcome

Response depth

BBD (n = 16)

BTD (n = 14)

Total (n = 30)

Fisher’s

N

%

N

%

N

%

P

sFLC response

vGPR

13

81

3

22

16

54

0.003

After 2 cycles

PR

2

13

8

57

10

33

 

MR

0

0

1

7

1

3

 

SD

1

6

1

7

2

7

 

PD

0

0

1

7

1

3

 

Renal response

CR/PR

5

31

1

7

6

19

0.12

After 4 cycles

MR

3

19

7

47

10

32

 

No response

3

19

1

7

4

13

 

QoL

Timepoint

BBD

BTD

T-Test p

N

Mean

SD

N

Mean

SD

EQ-5D score

Baseline

8

0.72

0.15

9

0.69

0.35

 
 

1 month FU

8

0.69

0.19

9

0.80

0.28

 
 

Change

8

−0.04

0.19

9

0.11

0.39

0.33

EQ VAS score

Baseline

8

59

19

8

59

19

 
 

1 month FU

8

69

19

9

84

15

 
 

Change

8

10

21

8

13

13

0.72

  1. The EQ-5D descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is scored on a scale of 1 to 3. Higher score equates to a worse outcome.
  2. vGPR very good partial response, PR partial response, MR minimal response, SD stable disease, PD progressive disease, CR complete response.
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