NCT02099539 · OUTCOME

Characterization of the Pharmacokinetic Profile - Time of the Observed Maximum Concentration (Tmax)

QUILT-3.005: A Study of N-803 in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2024-09-26

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

Measure: MEDIAN
Unit: Hours
Interval / dispersion: Full Range
Time frame: PK timepoint up to 72 hours +/- 6 hours

What was measured

time of the observed maximum concentration (Tmax)

Analysis population: Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects

Groups in this outcome

Cohort 1: N-803 - IV 1 ug/kg

N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles

Cohort 2: N-803 - IV 3 ug/kg

Cohort 3: N-803 - IV 6 ug/kg

Cohort 4: N-803 - IV 10 ug/kg

Cohort 5: N-803 - SQ 10 ug/kg

Cohort 6: N-803 - SQ 15 ug/kg

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
Cohort 1: N-803 - IV 1 ug/kg	3
Cohort 2: N-803 - IV 3 ug/kg	3
Cohort 3: N-803 - IV 6 ug/kg	3
Cohort 4: N-803 - IV 10 ug/kg	3
Cohort 5: N-803 - SQ 10 ug/kg	4
Cohort 6: N-803 - SQ 15 ug/kg	3

Reported measurements

Source class 1

Values in Hours · Interval/dispersion: Full Range
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: N-803 - IV 1 ug/kg	0.583	Not reported	0.5	0.683	Not reported
Cohort 2: N-803 - IV 3 ug/kg	0.583	Not reported	0.5	0.633	Not reported
Cohort 3: N-803 - IV 6 ug/kg	0.65	Not reported	0.633	0.717	Not reported
Cohort 4: N-803 - IV 10 ug/kg	0.667	Not reported	0.667	2.33	Not reported
Cohort 5: N-803 - SQ 10 ug/kg	33.1	Not reported	4.22	65.9	Not reported
Cohort 6: N-803 - SQ 15 ug/kg	6.0	Not reported	2.0	20.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
0.5
upper Limit
0.683
value
0.583
group Id
OG001
lower Limit
0.5
upper Limit
0.633
value
0.583
group Id
OG002
lower Limit
0.633
upper Limit
0.717
value
0.65
group Id
OG003
lower Limit
0.667
upper Limit
2.33
value
0.667
group Id
OG004
lower Limit
4.22
upper Limit
65.9
value
33.1
group Id
OG005
lower Limit
2.0
upper Limit
20.3
value
6.0

denoms

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

description

time of the observed maximum concentration (Tmax)

dispersion Type

Full Range

groups

description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG000
title
Cohort 1: N-803 - IV 1 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG001
title
Cohort 2: N-803 - IV 3 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG002
title
Cohort 3: N-803 - IV 6 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG003
title
Cohort 4: N-803 - IV 10 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG004
title
Cohort 5: N-803 - SQ 10 ug/kg
description
N-803: Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
id
OG005
title
Cohort 6: N-803 - SQ 15 ug/kg

param Type

MEDIAN

population Description

Cohort 7: N-803 - SQ 20 ug/kg did not enroll any subjects

reporting Status

POSTED

time Frame

PK timepoint up to 72 hours +/- 6 hours

title

Characterization of the Pharmacokinetic Profile - Time of the Observed Maximum Concentration (Tmax)

type

SECONDARY

unit Of Measure

Hours

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Preserved source evidence · Not medical advice