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NCT02099539 · OUTCOME

Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Clearance (CL/F)

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
mL/hr/kg
Interval / dispersion
Full Range
Time frame
PK timepoint up to 72 hours +/- 6 hours

What was measured

Apparent (Extravascular) Clearance (CL/F)

Analysis population: In addition, 6 out of 7 SC patients (Cohorts 5 and 6) had insufficient measurable post-tmax sampling to allow for evaluation of the terminal phase-dependent PK parameters (ie, t½, CL/F, Vz/F, AUC0-168, AUC0-∞).

Groups in this outcome

Cohort 5: N-803 - SQ 10 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 6: N-803 - SQ 15 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

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

Analysis denominator · Participants

GroupSource count
Cohort 5: N-803 - SQ 10 ug/kg0
Cohort 6: N-803 - SQ 15 ug/kg1

Reported measurements

Source class 1
Values in mL/hr/kg · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 6: N-803 - SQ 15 ug/kg462Not reported462462Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG001
        lower Limit
        462
        upper Limit
        462
        value
        462
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      1
    units
    Participants
description
Apparent (Extravascular) Clearance (CL/F)
dispersion Type
Full Range
groups
  1. 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 5: N-803 - SQ 10 ug/kg
  2. 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 6: N-803 - SQ 15 ug/kg
param Type
MEAN
population Description
In addition, 6 out of 7 SC patients (Cohorts 5 and 6) had insufficient measurable post-tmax sampling to allow for evaluation of the terminal phase-dependent PK parameters (ie, t½, CL/F, Vz/F, AUC0-168, AUC0-∞).
reporting Status
POSTED
time Frame
PK timepoint up to 72 hours +/- 6 hours
title
Characterization of the Pharmacokinetic Profile - Apparent (Extravascular) Clearance (CL/F)
type
SECONDARY
unit Of Measure
mL/hr/kg

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

Preserved source evidence · Not medical advice