Table 1 Demographic and baseline... | American Society of Hematology

Table 1

Demographic and baseline characteristics

Characteristic	Part 1										Part 2
	Daratumumab 2 mg/kg + lenalidomide/dexamethasone (n = 3)		Daratumumab 4 mg/kg + lenalidomide/dexamethasone (n = 3)		Daratumumab 8 mg/kg + lenalidomide/dexamethasone (n = 4)		Daratumumab 16 mg/kg + lenalidomide/dexamethasone (n = 3)		Total (N = 13)		Daratumumab 16 mg/kg + lenalidomide/dexamethasone (N = 32)
	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%
Median age, y (range)	69.0 (48-71)		62.0 (61-65)		56.0 (49-69)		70.0 (56-76)		62.0 (48-76)		59.5 (41-76)
Sex
Female		0		33		0		67		23		31
Male		100		67		100		33		77		69
ECOG score
0	2	66.7	2	66.7	1	25	3	100	8	61.5	19	59.4
1	1	33.3	1	33.3	3	75	0	0	5	38.5	12	37.5
2	0	0	0	0	0	0	0	0	0	0	1	3.1
No. of prior therapies
Median (range)	3.0 (3-4)		2.0 (2-3)		3.0 (3-4)		3.0 (2-4)		3.0 (2-4)		2.0 (1-3)
≥2	3	100	3	100	4	100	3	100	13	100	17	53.1
Prior treatment
IMiD	3	100	3	100	4	100	3	100	13	100	23	71.9
Lenalidomide	3	100	3	100	3	75	1	33.3	10	76.9	11	34.4
Thalidomide	1	33.3	0	0	3	75	3	100	7	53.8	14	43.8
PI	3	100	2	66.7	4	100	3	100	12	92.3	29	90.6
Bortezomib	3	100	2	66.7	4	100	3	100	12	92.3	28	87.5
PI + IMiD*	3	100	2	66.7	4	100	3	100	12	92.3	21	65.6
Bortezomib + lenalidomide*	3	100	2	66.7	3	75	1	33.3	9	69.2	9	28.1
Autologous stem cell transplantation	1	33.3	2	66.7	4	100	2	66.7	9	69.2	25	78.1
Prior chemotherapy†	3	100	3	100	4	100	3	100	13	100	32	100
Alkylating agents	3	100	3	100	4	100	3	100	13	100	29	90.6
Anthracyclines	1	33.3	2	66.7	3	75	2	66.7	8	61.5	15	46.9
Refractory to last line of therapy	0		1	33.3	3	75	1	33.3	5	38.5	7	21.9
Refractory to therapy containing
Lenalidomide	0		1	33.3	2	50	1	33.3	4	30.8	1	3.1
Bortezomib	0		2	66.7	3	75	1	33.3	6	46.2	5	15.6
Alkylating agents	0		0		2	50	1	33.3	3	23.1	3	9.4
PI only	0		2	66.7	0		0		2	15.4	5	15.6
IMiD only	0		1	33.3	0		1	33.3	2	15.4	1	3.1

Characteristic	Part 1										Part 2
	Daratumumab 2 mg/kg + lenalidomide/dexamethasone (n = 3)		Daratumumab 4 mg/kg + lenalidomide/dexamethasone (n = 3)		Daratumumab 8 mg/kg + lenalidomide/dexamethasone (n = 4)		Daratumumab 16 mg/kg + lenalidomide/dexamethasone (n = 3)		Total (N = 13)		Daratumumab 16 mg/kg + lenalidomide/dexamethasone (N = 32)
	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%
Median age, y (range)	69.0 (48-71)		62.0 (61-65)		56.0 (49-69)		70.0 (56-76)		62.0 (48-76)		59.5 (41-76)
Sex
Female		0		33		0		67		23		31
Male		100		67		100		33		77		69
ECOG score
0	2	66.7	2	66.7	1	25	3	100	8	61.5	19	59.4
1	1	33.3	1	33.3	3	75	0	0	5	38.5	12	37.5
2	0	0	0	0	0	0	0	0	0	0	1	3.1
No. of prior therapies
Median (range)	3.0 (3-4)		2.0 (2-3)		3.0 (3-4)		3.0 (2-4)		3.0 (2-4)		2.0 (1-3)
≥2	3	100	3	100	4	100	3	100	13	100	17	53.1
Prior treatment
IMiD	3	100	3	100	4	100	3	100	13	100	23	71.9
Lenalidomide	3	100	3	100	3	75	1	33.3	10	76.9	11	34.4
Thalidomide	1	33.3	0	0	3	75	3	100	7	53.8	14	43.8
PI	3	100	2	66.7	4	100	3	100	12	92.3	29	90.6
Bortezomib	3	100	2	66.7	4	100	3	100	12	92.3	28	87.5
PI + IMiD*	3	100	2	66.7	4	100	3	100	12	92.3	21	65.6
Bortezomib + lenalidomide*	3	100	2	66.7	3	75	1	33.3	9	69.2	9	28.1
Autologous stem cell transplantation	1	33.3	2	66.7	4	100	2	66.7	9	69.2	25	78.1
Prior chemotherapy†	3	100	3	100	4	100	3	100	13	100	32	100
Alkylating agents	3	100	3	100	4	100	3	100	13	100	29	90.6
Anthracyclines	1	33.3	2	66.7	3	75	2	66.7	8	61.5	15	46.9
Refractory to last line of therapy	0		1	33.3	3	75	1	33.3	5	38.5	7	21.9
Refractory to therapy containing
Lenalidomide	0		1	33.3	2	50	1	33.3	4	30.8	1	3.1
Bortezomib	0		2	66.7	3	75	1	33.3	6	46.2	5	15.6
Alkylating agents	0		0		2	50	1	33.3	3	23.1	3	9.4
PI only	0		2	66.7	0		0		2	15.4	5	15.6
IMiD only	0		1	33.3	0		1	33.3	2	15.4	1	3.1

ECOG, Eastern Cooperative Oncology Group.

Patients may have received these agents in different treatment regimens.

Includes either alkylating agents or autologous stem cell transplantation.