NCT02099539 · OUTCOME

Characterization of the Pharmacokinetic Profile - Maximum Observed Concentration (Cmax)

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: MEAN
Unit: ng/mL
Interval / dispersion: Standard Deviation
Time frame: PK timepoint up to 72 hours +/- 6 hours

What was measured

maximum observed concentration (Cmax)

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 ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Cohort 1: N-803 - IV 1 ug/kg	8.45	1.78	Not reported	Not reported	Not reported
Cohort 2: N-803 - IV 3 ug/kg	42.7	1.76	Not reported	Not reported	Not reported
Cohort 3: N-803 - IV 6 ug/kg	142	26.6	Not reported	Not reported	Not reported
Cohort 4: N-803 - IV 10 ug/kg	144	70.7	Not reported	Not reported	Not reported
Cohort 5: N-803 - SQ 10 ug/kg	0.383	0.111	Not reported	Not reported	Not reported
Cohort 6: N-803 - SQ 15 ug/kg	1.69	1.41	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
1.78
value
8.45
group Id
OG001
spread
1.76
value
42.7
group Id
OG002
spread
26.6
value
142
group Id
OG003
spread
70.7
value
144
group Id
OG004
spread
0.111
value
0.383
group Id
OG005
spread
1.41
value
1.69

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

maximum observed concentration (Cmax)

dispersion Type

Standard Deviation

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

MEAN

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 - Maximum Observed Concentration (Cmax)

type

SECONDARY

unit Of Measure

ng/mL

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Preserved source evidence · Not medical advice