Table 1 Baseline characteristics and... | American Society of Hematology

Table 1

Baseline characteristics and refractory status among patients receiving daratumumab 16 mg/kg

Characteristic	GEN501 (n = 42)		SIRIUS (n = 106)		Combined studies (N = 148)
Characteristic	No.	%	No.	%	No.	%
Age, y
Median (range)	64.0 (44-76)		63.5 (31-84)		64.0 (31-84)
65 to <75	16	38	36	34	52	35
≥75	4	10	12	11	16	11
Sex
Female	15	36	54	51	69	47
Male	27	64	52	49	79	53
ECOG performance score
0	12	29	29	27	41	28
1	28	67	69	65	97	66
2	2	5	8	8	10	7
No. of extramedullary plasmacytomas
0	38	90	92	87	130	88
≥1	4	10	14	13	18	12
Cytogenetic profile*
t(4;14)			9	10
del17p			16	17
del13q			30	32
amp1q21			23	24
Other			43	45
Median time since diagnosis, y (range)	5.8 (0.8-23.7)		4.8 (1.1-23.8)		5.1 (0.8-23.8)
Renal function at baseline (creatinine clearance), mL/min
≥60	29	69	60	57	89	60
≥30 to <60	12	29	42	40	54	37
<30	1	2	4	4	5	3
Bone marrow percent plasma cells at baseline, N	42		104		146
≤30	37	88	48	46	85	58
>30 to ≤60	5	12	21	20	26	18
>60	0	0	35	34	35	24
No. of prior lines of therapy
Median (range)	4 (2-12)		5 (2-14)		5 (2-14)
>3	26	62	87	82	113	76
Prior ASCT	31	74	85	80	116	78
Prior PI	42	100	106	100	148	100
Bortezomib	42	100	105	99	147	99
Carfilzomib	8	19	53	50	61	41
Prior IMiD	40	95	106	100	146	99
Lenalidomide	40	95	105	99	145	98
Pomalidomide	15	36	67	63	82	55
Thalidomide	19	45	47	44	66	45
Refractory to:
Last line of therapy	32	76	103	97	135	91
Both a PI and an IMiD	27	64	101	95	128	87
PI only	3	7	3	3	6	4
IMiD only	4	10	1	1	5	3
PI + IMiD + alkylating agent	21	50	79	75	100	68
Bortezomib	30	71	95	90	125	85
Carfilzomib	7	17	51	48	58	39
Lenalidomide	31	74	93	88	124	84
Pomalidomide	15	36	67	63	82	55
Thalidomide	12	29	29	27	41	28
Alkylating agent only	25	60	82	77	107	72

Characteristic	GEN501 (n = 42)		SIRIUS (n = 106)		Combined studies (N = 148)
Characteristic	No.	%	No.	%	No.	%
Age, y
Median (range)	64.0 (44-76)		63.5 (31-84)		64.0 (31-84)
65 to <75	16	38	36	34	52	35
≥75	4	10	12	11	16	11
Sex
Female	15	36	54	51	69	47
Male	27	64	52	49	79	53
ECOG performance score
0	12	29	29	27	41	28
1	28	67	69	65	97	66
2	2	5	8	8	10	7
No. of extramedullary plasmacytomas
0	38	90	92	87	130	88
≥1	4	10	14	13	18	12
Cytogenetic profile*
t(4;14)			9	10
del17p			16	17
del13q			30	32
amp1q21			23	24
Other			43	45
Median time since diagnosis, y (range)	5.8 (0.8-23.7)		4.8 (1.1-23.8)		5.1 (0.8-23.8)
Renal function at baseline (creatinine clearance), mL/min
≥60	29	69	60	57	89	60
≥30 to <60	12	29	42	40	54	37
<30	1	2	4	4	5	3
Bone marrow percent plasma cells at baseline, N	42		104		146
≤30	37	88	48	46	85	58
>30 to ≤60	5	12	21	20	26	18
>60	0	0	35	34	35	24
No. of prior lines of therapy
Median (range)	4 (2-12)		5 (2-14)		5 (2-14)
>3	26	62	87	82	113	76
Prior ASCT	31	74	85	80	116	78
Prior PI	42	100	106	100	148	100
Bortezomib	42	100	105	99	147	99
Carfilzomib	8	19	53	50	61	41
Prior IMiD	40	95	106	100	146	99
Lenalidomide	40	95	105	99	145	98
Pomalidomide	15	36	67	63	82	55
Thalidomide	19	45	47	44	66	45
Refractory to:
Last line of therapy	32	76	103	97	135	91
Both a PI and an IMiD	27	64	101	95	128	87
PI only	3	7	3	3	6	4
IMiD only	4	10	1	1	5	3
PI + IMiD + alkylating agent	21	50	79	75	100	68
Bortezomib	30	71	95	90	125	85
Carfilzomib	7	17	51	48	58	39
Lenalidomide	31	74	93	88	124	84
Pomalidomide	15	36	67	63	82	55
Thalidomide	12	29	29	27	41	28
Alkylating agent only	25	60	82	77	107	72

ASCT, autologous stem cell transplantation; ECOG, Eastern Cooperative Oncology Group.

Cytogenetic data were not assessed in GEN501.