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NCT03340883 · OUTCOME

Bioanalytical Measures (Phase 1 and Phase 2)

Safety and Tolerability of BION-1301 in Adults With Relapsed or Refractory Multiple Myeloma (MM) · Source last updated 2021-04-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEDIAN
Unit: percentage change
Interval / dispersion: Inter-Quartile Range
Time frame: Baseline and approximately 2 years

What was measured

Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline

Analysis population: Some laboratory tests were not performed for some of the participants. Therefore, the number analyzed does not always match the overall number of participants analyzed. Study was terminated early and Phase 2 did not enroll.

Groups in this outcome

BION-1301 50 mg Q2W

50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.

BION-1301 150 mg Q2W

150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 450 mg Q2W

450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 1350 mg Q2W

1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 2700 mg Q2W

2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.

BION-1301 1350 mg QW*8W->Q2W

1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	4
BION-1301 150 mg Q2W	3
BION-1301 450 mg Q2W	4
BION-1301 1350 mg Q2W	4
BION-1301 2700 mg Q2W	3
BION-1301 1350 mg QW*8W->Q2W	3

Reported measurements

Serum A/G Ratio (RATIO)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	2
BION-1301 150 mg Q2W	2
BION-1301 450 mg Q2W	1
BION-1301 1350 mg Q2W	0
BION-1301 2700 mg Q2W	2
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	24.763	Not reported	18.182	31.343	Not reported
BION-1301 150 mg Q2W	31.538	Not reported	23.077	40.000	Not reported
BION-1301 450 mg Q2W	28.571	Not reported	28.571	28.571	Not reported
BION-1301 2700 mg Q2W	20.202	Not reported	18.182	22.222	Not reported

Serum Albumin (g/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	2
BION-1301 150 mg Q2W	3
BION-1301 450 mg Q2W	2
BION-1301 1350 mg Q2W	4
BION-1301 2700 mg Q2W	3
BION-1301 1350 mg QW*8W->Q2W	1

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	40.191	Not reported	27.326	53.056	Not reported
BION-1301 150 mg Q2W	5.405	Not reported	5.217	28.000	Not reported
BION-1301 450 mg Q2W	10.591	Not reported	6.897	14.286	Not reported
BION-1301 1350 mg Q2W	9.294	Not reported	3.808	17.042	Not reported
BION-1301 2700 mg Q2W	3.571	Not reported	2.778	13.587	Not reported
BION-1301 1350 mg QW*8W->Q2W	7.979	Not reported	7.979	7.979	Not reported

Serum Alpha-1 Globulin (g/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	2
BION-1301 150 mg Q2W	1
BION-1301 450 mg Q2W	2
BION-1301 1350 mg Q2W	1
BION-1301 2700 mg Q2W	1
BION-1301 1350 mg QW*8W->Q2W	3

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	18.698	Not reported	14.815	22.581	Not reported
BION-1301 150 mg Q2W	30.556	Not reported	30.556	30.556	Not reported
BION-1301 450 mg Q2W	29.710	Not reported	26.087	33.333	Not reported
BION-1301 1350 mg Q2W	24.138	Not reported	24.138	24.138	Not reported
BION-1301 2700 mg Q2W	16.129	Not reported	16.129	16.129	Not reported
BION-1301 1350 mg QW*8W->Q2W	20.000	Not reported	18.919	50.000	Not reported

Serum Alpha-2 Globulin (g/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	3
BION-1301 150 mg Q2W	1
BION-1301 450 mg Q2W	3
BION-1301 1350 mg Q2W	3
BION-1301 2700 mg Q2W	1
BION-1301 1350 mg QW*8W->Q2W	3

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	2.985	Not reported	2.439	20.408	Not reported
BION-1301 150 mg Q2W	31.579	Not reported	31.579	31.579	Not reported
BION-1301 450 mg Q2W	14.286	Not reported	13.415	14.754	Not reported
BION-1301 1350 mg Q2W	10.843	Not reported	9.756	12.037	Not reported
BION-1301 2700 mg Q2W	14.286	Not reported	14.286	14.286	Not reported
BION-1301 1350 mg QW*8W->Q2W	10.000	Not reported	4.918	33.333	Not reported

Serum Beta Globulin (g/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	1
BION-1301 150 mg Q2W	1
BION-1301 450 mg Q2W	1
BION-1301 1350 mg Q2W	1
BION-1301 2700 mg Q2W	2
BION-1301 1350 mg QW*8W->Q2W	1

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	33.636	Not reported	33.636	33.636	Not reported
BION-1301 150 mg Q2W	3.125	Not reported	3.125	3.125	Not reported
BION-1301 450 mg Q2W	0.542	Not reported	0.542	0.542	Not reported
BION-1301 1350 mg Q2W	22.472	Not reported	22.472	22.472	Not reported
BION-1301 2700 mg Q2W	8.571	Not reported	7.143	10.000	Not reported
BION-1301 1350 mg QW*8W->Q2W	2.609	Not reported	2.609	2.609	Not reported

Serum Gamma Globulin (g/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	3
BION-1301 150 mg Q2W	1
BION-1301 450 mg Q2W	3
BION-1301 1350 mg Q2W	2
BION-1301 2700 mg Q2W	1
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	13.920	Not reported	8.511	41.667	Not reported
BION-1301 150 mg Q2W	96.552	Not reported	96.552	96.552	Not reported
BION-1301 450 mg Q2W	25.926	Not reported	15.789	50.000	Not reported
BION-1301 1350 mg Q2W	23.441	Not reported	22.807	24.074	Not reported
BION-1301 2700 mg Q2W	0.627	Not reported	0.627	0.627	Not reported

Serum Immunoglobulin A (g/L)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	1
BION-1301 150 mg Q2W	1
BION-1301 450 mg Q2W	2
BION-1301 1350 mg Q2W	2
BION-1301 2700 mg Q2W	3
BION-1301 1350 mg QW*8W->Q2W	1

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	1.615	Not reported	1.615	1.615	Not reported
BION-1301 150 mg Q2W	66.667	Not reported	66.667	66.667	Not reported
BION-1301 450 mg Q2W	36.174	Not reported	0.717	71.631	Not reported
BION-1301 1350 mg Q2W	30.536	Not reported	12.500	48.571	Not reported
BION-1301 2700 mg Q2W	23.077	Not reported	16.667	70.588	Not reported
BION-1301 1350 mg QW*8W->Q2W	23.077	Not reported	23.077	23.077	Not reported

Serum Immunoglobulin G (g/L)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	2
BION-1301 150 mg Q2W	2
BION-1301 450 mg Q2W	2
BION-1301 1350 mg Q2W	2
BION-1301 2700 mg Q2W	0
BION-1301 1350 mg QW*8W->Q2W	1

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	25.274	Not reported	8.312	42.236	Not reported
BION-1301 150 mg Q2W	25.000	Not reported	16.788	33.212	Not reported
BION-1301 450 mg Q2W	25.016	Not reported	22.566	27.467	Not reported
BION-1301 1350 mg Q2W	20.125	Not reported	14.888	25.362	Not reported
BION-1301 1350 mg QW*8W->Q2W	0.352	Not reported	0.352	0.352	Not reported

Serum Immunoglobulin M (g/L)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	3
BION-1301 150 mg Q2W	3
BION-1301 450 mg Q2W	1
BION-1301 1350 mg Q2W	2
BION-1301 2700 mg Q2W	2
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	27.273	Not reported	27.273	76.563	Not reported
BION-1301 150 mg Q2W	28.571	Not reported	14.286	40.000	Not reported
BION-1301 450 mg Q2W	40.000	Not reported	40.000	40.000	Not reported
BION-1301 1350 mg Q2W	61.364	Not reported	54.545	68.182	Not reported
BION-1301 2700 mg Q2W	64.148	Not reported	46.154	82.143	Not reported

Serum Kappa Light Chain, Free (mg/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	3
BION-1301 150 mg Q2W	1
BION-1301 450 mg Q2W	2
BION-1301 1350 mg Q2W	2
BION-1301 2700 mg Q2W	1
BION-1301 1350 mg QW*8W->Q2W	2

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	34.0000	Not reported	6.7568	46.4419	Not reported
BION-1301 150 mg Q2W	5.9735	Not reported	5.9735	5.9735	Not reported
BION-1301 450 mg Q2W	42.0349	Not reported	30.0000	54.0698	Not reported
BION-1301 1350 mg Q2W	72.4863	Not reported	69.3627	75.6098	Not reported
BION-1301 2700 mg Q2W	64.8649	Not reported	64.8649	64.8649	Not reported
BION-1301 1350 mg QW*8W->Q2W	47.9787	Not reported	30.0000	65.9574	Not reported

Serum Kappa LtChain,Free/LambdaLtChain,Free(RATIO)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	2
BION-1301 150 mg Q2W	0
BION-1301 450 mg Q2W	1
BION-1301 1350 mg Q2W	2
BION-1301 2700 mg Q2W	1
BION-1301 1350 mg QW*8W->Q2W	1

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	53.919	Not reported	50.000	57.838	Not reported
BION-1301 450 mg Q2W	50.000	Not reported	50.000	50.000	Not reported
BION-1301 1350 mg Q2W	100.000	Not reported	100.000	100.000	Not reported
BION-1301 2700 mg Q2W	60.000	Not reported	60.000	60.000	Not reported
BION-1301 1350 mg QW*8W->Q2W	100.000	Not reported	100.000	100.000	Not reported

Serum Lambda Light Chain, Free (mg/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	2
BION-1301 150 mg Q2W	2
BION-1301 450 mg Q2W	3
BION-1301 1350 mg Q2W	2
BION-1301 2700 mg Q2W	2
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	13.9651	Not reported	7.0000	20.9302	Not reported
BION-1301 150 mg Q2W	26.3520	Not reported	11.1111	41.5929	Not reported
BION-1301 450 mg Q2W	13.4372	Not reported	13.4028	57.6642	Not reported
BION-1301 1350 mg Q2W	26.9335	Not reported	12.5000	41.3669	Not reported
BION-1301 2700 mg Q2W	24.5619	Not reported	20.0000	29.1237	Not reported

Serum Monoclonal Protein Spike (g/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	3
BION-1301 150 mg Q2W	0
BION-1301 450 mg Q2W	1
BION-1301 1350 mg Q2W	1
BION-1301 2700 mg Q2W	0
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	13.1579	Not reported	1.0526	50.0000	Not reported
BION-1301 450 mg Q2W	5.4670	Not reported	5.4670	5.4670	Not reported
BION-1301 1350 mg Q2W	27.2727	Not reported	27.2727	27.2727	Not reported

Serum Protein (g/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	1
BION-1301 150 mg Q2W	0
BION-1301 450 mg Q2W	2
BION-1301 1350 mg Q2W	1
BION-1301 2700 mg Q2W	1
BION-1301 1350 mg QW*8W->Q2W	2

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 50 mg Q2W	8.14	Not reported	8.14	8.14	Not reported
BION-1301 450 mg Q2W	3.06	Not reported	2.88	3.23	Not reported
BION-1301 1350 mg Q2W	3.03	Not reported	3.03	3.03	Not reported
BION-1301 2700 mg Q2W	6.74	Not reported	6.74	6.74	Not reported
BION-1301 1350 mg QW*8W->Q2W	3.05	Not reported	1.69	4.41	Not reported

Urine Albumin (mg/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	0
BION-1301 150 mg Q2W	1
BION-1301 450 mg Q2W	0
BION-1301 1350 mg Q2W	0
BION-1301 2700 mg Q2W	2
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 150 mg Q2W	18.1818	Not reported	18.1818	18.1818	Not reported
BION-1301 2700 mg Q2W	54.7349	Not reported	20.6055	88.8643	Not reported

Urine Alpha-1 Globulin (mg/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	0
BION-1301 150 mg Q2W	1
BION-1301 450 mg Q2W	0
BION-1301 1350 mg Q2W	0
BION-1301 2700 mg Q2W	2
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 150 mg Q2W	80.0000	Not reported	80.0000	80.0000	Not reported
BION-1301 2700 mg Q2W	71.7418	Not reported	60.4982	82.9854	Not reported

Urine Alpha-2 Globulin (mg/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	0
BION-1301 150 mg Q2W	0
BION-1301 450 mg Q2W	0
BION-1301 1350 mg Q2W	0
BION-1301 2700 mg Q2W	2
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 2700 mg Q2W	63.5621	Not reported	37.2727	89.8515	Not reported

Urine Beta Globulin (mg/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	0
BION-1301 150 mg Q2W	0
BION-1301 450 mg Q2W	0
BION-1301 1350 mg Q2W	1
BION-1301 2700 mg Q2W	2
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 1350 mg Q2W	19.4996	Not reported	19.4996	19.4996	Not reported
BION-1301 2700 mg Q2W	49.3411	Not reported	6.6748	92.0074	Not reported

Urine Gamma Globulin (mg/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	0
BION-1301 150 mg Q2W	1
BION-1301 450 mg Q2W	1
BION-1301 1350 mg Q2W	0
BION-1301 2700 mg Q2W	1
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 150 mg Q2W	90.3185	Not reported	90.3185	90.3185	Not reported
BION-1301 450 mg Q2W	100.0000	Not reported	100.0000	100.0000	Not reported
BION-1301 2700 mg Q2W	93.1735	Not reported	93.1735	93.1735	Not reported

Urine Monoclonal Protein Spike (%)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	0
BION-1301 150 mg Q2W	0
BION-1301 450 mg Q2W	0
BION-1301 1350 mg Q2W	1
BION-1301 2700 mg Q2W	1
BION-1301 1350 mg QW*8W->Q2W	1

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 1350 mg Q2W	2.755	Not reported	2.755	2.755	Not reported
BION-1301 2700 mg Q2W	30.695	Not reported	30.695	30.695	Not reported
BION-1301 1350 mg QW*8W->Q2W	11.819	Not reported	11.819	11.819	Not reported

Urine Protein (mg/dL)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	0
BION-1301 150 mg Q2W	0
BION-1301 450 mg Q2W	0
BION-1301 1350 mg Q2W	0
BION-1301 2700 mg Q2W	2
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 2700 mg Q2W	52.9665	Not reported	14.2857	91.6472	Not reported

Urine Protein, Calculated (mg/24hr)

Analysis denominator · Participants

Group	Source count
BION-1301 50 mg Q2W	0
BION-1301 150 mg Q2W	0
BION-1301 450 mg Q2W	1
BION-1301 1350 mg Q2W	0
BION-1301 2700 mg Q2W	2
BION-1301 1350 mg QW*8W->Q2W	0

Values in percentage change · Interval/dispersion: Inter-Quartile Range
Group	Value	Spread	Lower	Upper	Comment
BION-1301 450 mg Q2W	9.1743	Not reported	9.1743	9.1743	Not reported
BION-1301 2700 mg Q2W	42.9298	Not reported	15.0943	70.7652	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
18.182
upper Limit
31.343
value
24.763
group Id
OG001
lower Limit
23.077
upper Limit
40.000
value
31.538
group Id
OG002
lower Limit
28.571
upper Limit
28.571
value
28.571
group Id
OG004
lower Limit
18.182
upper Limit
22.222
value
20.202
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
0
group Id
OG004
value
2
group Id
OG005
value
0
units
Participants
title
Serum A/G Ratio (RATIO)
categories
measurements
group Id
OG000
lower Limit
27.326
upper Limit
53.056
value
40.191
group Id
OG001
lower Limit
5.217
upper Limit
28.000
value
5.405
group Id
OG002
lower Limit
6.897
upper Limit
14.286
value
10.591
group Id
OG003
lower Limit
3.808
upper Limit
17.042
value
9.294
group Id
OG004
lower Limit
2.778
upper Limit
13.587
value
3.571
group Id
OG005
lower Limit
7.979
upper Limit
7.979
value
7.979
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
4
group Id
OG004
value
3
group Id
OG005
value
1
units
Participants
title
Serum Albumin (g/dL)
categories
measurements
group Id
OG000
lower Limit
14.815
upper Limit
22.581
value
18.698
group Id
OG001
lower Limit
30.556
upper Limit
30.556
value
30.556
group Id
OG002
lower Limit
26.087
upper Limit
33.333
value
29.710
group Id
OG003
lower Limit
24.138
upper Limit
24.138
value
24.138
group Id
OG004
lower Limit
16.129
upper Limit
16.129
value
16.129
group Id
OG005
lower Limit
18.919
upper Limit
50.000
value
20.000
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
1
group Id
OG005
value
3
units
Participants
title
Serum Alpha-1 Globulin (g/dL)
categories
measurements
group Id
OG000
lower Limit
2.439
upper Limit
20.408
value
2.985
group Id
OG001
lower Limit
31.579
upper Limit
31.579
value
31.579
group Id
OG002
lower Limit
13.415
upper Limit
14.754
value
14.286
group Id
OG003
lower Limit
9.756
upper Limit
12.037
value
10.843
group Id
OG004
lower Limit
14.286
upper Limit
14.286
value
14.286
group Id
OG005
lower Limit
4.918
upper Limit
33.333
value
10.000
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
3
group Id
OG004
value
1
group Id
OG005
value
3
units
Participants
title
Serum Alpha-2 Globulin (g/dL)
categories
measurements
group Id
OG000
lower Limit
33.636
upper Limit
33.636
value
33.636
group Id
OG001
lower Limit
3.125
upper Limit
3.125
value
3.125
group Id
OG002
lower Limit
0.542
upper Limit
0.542
value
0.542
group Id
OG003
lower Limit
22.472
upper Limit
22.472
value
22.472
group Id
OG004
lower Limit
7.143
upper Limit
10.000
value
8.571
group Id
OG005
lower Limit
2.609
upper Limit
2.609
value
2.609
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
1
group Id
OG004
value
2
group Id
OG005
value
1
units
Participants
title
Serum Beta Globulin (g/dL)
categories
measurements
group Id
OG000
lower Limit
8.511
upper Limit
41.667
value
13.920
group Id
OG001
lower Limit
96.552
upper Limit
96.552
value
96.552
group Id
OG002
lower Limit
15.789
upper Limit
50.000
value
25.926
group Id
OG003
lower Limit
22.807
upper Limit
24.074
value
23.441
group Id
OG004
lower Limit
0.627
upper Limit
0.627
value
0.627
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
0
units
Participants
title
Serum Gamma Globulin (g/dL)
categories
measurements
group Id
OG000
lower Limit
1.615
upper Limit
1.615
value
1.615
group Id
OG001
lower Limit
66.667
upper Limit
66.667
value
66.667
group Id
OG002
lower Limit
0.717
upper Limit
71.631
value
36.174
group Id
OG003
lower Limit
12.500
upper Limit
48.571
value
30.536
group Id
OG004
lower Limit
16.667
upper Limit
70.588
value
23.077
group Id
OG005
lower Limit
23.077
upper Limit
23.077
value
23.077
denoms
counts
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
3
group Id
OG005
value
1
units
Participants
title
Serum Immunoglobulin A (g/L)
categories
measurements
group Id
OG000
lower Limit
8.312
upper Limit
42.236
value
25.274
group Id
OG001
lower Limit
16.788
upper Limit
33.212
value
25.000
group Id
OG002
lower Limit
22.566
upper Limit
27.467
value
25.016
group Id
OG003
lower Limit
14.888
upper Limit
25.362
value
20.125
group Id
OG005
lower Limit
0.352
upper Limit
0.352
value
0.352
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
0
group Id
OG005
value
1
units
Participants
title
Serum Immunoglobulin G (g/L)
categories
measurements
group Id
OG000
lower Limit
27.273
upper Limit
76.563
value
27.273
group Id
OG001
lower Limit
14.286
upper Limit
40.000
value
28.571
group Id
OG002
lower Limit
40.000
upper Limit
40.000
value
40.000
group Id
OG003
lower Limit
54.545
upper Limit
68.182
value
61.364
group Id
OG004
lower Limit
46.154
upper Limit
82.143
value
64.148
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
2
group Id
OG005
value
0
units
Participants
title
Serum Immunoglobulin M (g/L)
categories
measurements
group Id
OG000
lower Limit
6.7568
upper Limit
46.4419
value
34.0000
group Id
OG001
lower Limit
5.9735
upper Limit
5.9735
value
5.9735
group Id
OG002
lower Limit
30.0000
upper Limit
54.0698
value
42.0349
group Id
OG003
lower Limit
69.3627
upper Limit
75.6098
value
72.4863
group Id
OG004
lower Limit
64.8649
upper Limit
64.8649
value
64.8649
group Id
OG005
lower Limit
30.0000
upper Limit
65.9574
value
47.9787
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
1
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
2
units
Participants
title
Serum Kappa Light Chain, Free (mg/dL)
categories
measurements
group Id
OG000
lower Limit
50.000
upper Limit
57.838
value
53.919
group Id
OG002
lower Limit
50.000
upper Limit
50.000
value
50.000
group Id
OG003
lower Limit
100.000
upper Limit
100.000
value
100.000
group Id
OG004
lower Limit
60.000
upper Limit
60.000
value
60.000
group Id
OG005
lower Limit
100.000
upper Limit
100.000
value
100.000
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
0
group Id
OG002
value
1
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
1
units
Participants
title
Serum Kappa LtChain,Free/LambdaLtChain,Free(RATIO)
categories
measurements
group Id
OG000
lower Limit
7.0000
upper Limit
20.9302
value
13.9651
group Id
OG001
lower Limit
11.1111
upper Limit
41.5929
value
26.3520
group Id
OG002
lower Limit
13.4028
upper Limit
57.6642
value
13.4372
group Id
OG003
lower Limit
12.5000
upper Limit
41.3669
value
26.9335
group Id
OG004
lower Limit
20.0000
upper Limit
29.1237
value
24.5619
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
2
group Id
OG005
value
0
units
Participants
title
Serum Lambda Light Chain, Free (mg/dL)

denoms

counts
group Id
OG000
value
4
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
4
group Id
OG004
value
3
group Id
OG005
value
3
units
Participants

description

Relative change in serum and urine M-protein levels defined as the maximum reduction from baseline

dispersion Type

Inter-Quartile Range

groups

description
50 mg BION-1301 will be administered once every 2 weeks as an intravenous (IV) infusion.
id
OG000
title
BION-1301 50 mg Q2W
description
150 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
id
OG001
title
BION-1301 150 mg Q2W
description
450 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
id
OG002
title
BION-1301 450 mg Q2W
description
1350 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
id
OG003
title
BION-1301 1350 mg Q2W
description
2700 mg BION-1301 will be administered once every 2 weeks as an IV infusion.
id
OG004
title
BION-1301 2700 mg Q2W
description
1350 mg BION-1301 will be administered as an IV infusion once per week for up to 8 weeks, followed by dosing once every 2 weeks.
id
OG005
title
BION-1301 1350 mg QW*8W->Q2W

param Type

MEDIAN

population Description

Some laboratory tests were not performed for some of the participants. Therefore, the number analyzed does not always match the overall number of participants analyzed. Study was terminated early and Phase 2 did not enroll.

reporting Status

POSTED

time Frame

Baseline and approximately 2 years

title

Bioanalytical Measures (Phase 1 and Phase 2)

type

PRIMARY

unit Of Measure

percentage change

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice