Induction therapy with bortezomib and dexamethasone followed by autologous stem cell transplantation versus autologous stem cell transplantation alone in the treatment of renal AL amyloidosis: a randomized controlled trial

Table 1 Patient characteristics

Characteristic	BD + HDM/SCT (number = 28)	HDM/SCT (number = 28)	Pvalue
Age (years)
Median	53	51.5	0.23
Range	38-65	37-63	0.23
Male/female (number)	18/10	16/12	0.78
Organ involvement, number (%)
Kidney	28 (100)	28 (100)	1.0
Heart	17 (60.7)	15 (53.5)	0.79
Liver	1 (3.6)	3 (10.7)	0.61
Nervous system	3 (10.7)	2 (7.1)	1.0
>1 organ involved	17 (60.7)	16 (57.1)	1.0
Cardiac stage, number (%)^a
I	14 (50)	12 (42.9)	0.86
II	10 (35.7)	11 (39.3)
III	4 (14.3)	5 (17.8)
Involved FLC, number (%)
κ	3 (10.7)	2 (7.1)	1.0
λ	25 (89.3)	26 (92.9)
Abnormal FLC κ-to-λ ratio number (%)	26 (92.9)	27 (96.4)	1.0
ECOG PS (0/1/2), number (%)
0	13 (44.4)	14 (46.2)	0.75
1	10 (37)	11 (42.3)
2	5 (18.6)	3 (11.5)
24-hour urine protein (g/24 hour)	4.6 ± 2.2	5.8 ± 4.1	0.18
Albumin (g/L)	26.8 ± 6.1	25.7 ± 4.9	0.44
Creatinine (mg/dL)	0.8 ± 0.3	0.8 ± 0.4	0.72
GFR (mL/min)	89.0 ± 19.6	85.1 ± 25.6	0.53
Marrow plasma cells (%)	3.2 ± 2.7	2.8 ± 2.1	0.59
Echocardiogram septal thickness (mm)	11.7 ± 2.4	11.1 ± 1.8	0.33
Ejection fraction (%)	60.8 ± 6.5	62.7 ± 6.1	0.27
Alkaline phosphatasea (U/L)
Median	58	49	0.11
Range	23 to 321	33 to 661	0.11
NT-proBNP (ng/L)
Median	268	249	0.32
Range	55.5 to 13,730	15.2 to 7,709
>8500 ng/L (%)	1 (3.6)	1 (3.6)
BNP (ng/L)
Median	117	120	0.85
Range	22 to 3,261	17 to 3,078
Troponin-I (ng/ml)
Median	0.003	0.003	0.83
Range	0 to 0.15	0 to 0.12
iFLC (mg/L)
Median	114.9	97.8	0.15
Range	25 to 516	24 to 204
dFLC (mg/L)
Median	96.1	64.8	0,12
Range	14 to 471	14 to 163
>180 mg/L (%)	2 (7.1)	0

^aThe upper reference limit for alkaline phosphatase is 172 U/L. BNP, brain natriuretic peptide; ECOG PS, Eastern Cooperative Oncology Group performance status; FLC, free light chain; GFR, glomerular filtration rate.

ISSN: 1741-7015