A Phase II Trial of Ofatumumab in Subjects With Waldenstrom's Macroglobulinemia · Source last updated 2017-05-30
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
GEOMETRIC_MEAN
Unit
micrograms/milliliter (µg/ml)
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
What was measured
Cmax is defined as the maximum observed drug concentration after administration, and Ctrough is defined as the drug concentration observed prior to the start of the next dose. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.
Analysis population: PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be determined.
Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
386
upper Limit
561
value
465
title
Cmax, Course 1 Dose 3, n=0,19
categories
measurements
group Id
OG000
lower Limit
195
upper Limit
344
value
259
comment
No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.
group Id
OG001
lower Limit
NA
upper Limit
NA
value
NA
title
Cmax, Course 1 Dose 4, n=13,0
categories
measurements
comment
No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
523
upper Limit
783
value
640
title
Cmax, Course 1 Dose 5, n=0,18
categories
measurements
group Id
OG000
lower Limit
0.3
upper Limit
27.4
value
3.0
group Id
OG001
lower Limit
2.0
upper Limit
32.2
value
8.0
title
Ctrough, Course 1 Dose 2, n=7,12
categories
measurements
group Id
OG000
lower Limit
2.1
upper Limit
91.3
value
13.9
group Id
OG001
lower Limit
67.3
upper Limit
217
value
121
title
Ctrough, Course 1 Dose 3, n=11,19
categories
measurements
group Id
OG000
lower Limit
4.3
upper Limit
128
value
23.4
group Id
OG001
lower Limit
95.3
upper Limit
344
value
181
title
Ctrough, Course 1 Dose 4, n=13,21
categories
measurements
comment
No participants were analyzed at the indicated time point; therefore, the mean and the CI could not be calculated.
group Id
OG000
lower Limit
NA
upper Limit
NA
value
NA
group Id
OG001
lower Limit
127
upper Limit
489
value
249
title
Ctrough, Course 1 Dose 5, n=0,18
categories
measurements
group Id
OG000
lower Limit
33.1
upper Limit
85.6
value
53.2
group Id
OG001
lower Limit
42.8
upper Limit
98.2
value
64.8
title
Cmax, Course 2 Dose 1, n=9,11
categories
measurements
group Id
OG000
lower Limit
420
upper Limit
730
value
554
group Id
OG001
lower Limit
436
upper Limit
762
value
577
title
Cmax, Course 2 Dose 3, n=8,12
categories
measurements
group Id
OG000
lower Limit
339
upper Limit
825
value
528
group Id
OG001
lower Limit
616
upper Limit
1046
value
803
title
Cmax, Course 2 Dose 5, n=10,12
categories
measurements
group Id
OG000
lower Limit
1.2
upper Limit
52.7
value
8.1
group Id
OG001
lower Limit
4.7
upper Limit
89.2
value
20.4
title
Ctrough, Course 2 Dose 2, n=7,10
denoms
counts
group Id
OG000
value
15
group Id
OG001
value
21
units
Participants
description
Cmax is defined as the maximum observed drug concentration after administration, and Ctrough is defined as the drug concentration observed prior to the start of the next dose. Blood samples for the quantification of ofatumumab were collected during each cycle and for up to 6 months after the end of each cycle.
dispersion Type
95% Confidence Interval
groups
description
Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks \[Weeks (Wk.) 1 through 4\]) (300 milligrams \[mg\] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks \[Weeks 1 through 5\]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
PK Population. Data were provided for the number of participants attending each visit for whom the parameter could be determined.
reporting Status
POSTED
time Frame
From the first dose (Cycle 1 Day 1) up to 6 months after the end of the last cycle of treatment; blood collected on each dosing day, weekly up to Week 8, and every 4 weeks up to Week 24/Month 7
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