Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02099539 · OUTCOME

Characterization of the Pharmacokinetic Profile - Vss Volume of Distribution at Steady State

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

What was measured

Vss Volume of distribution at steady state is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration

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

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 3: N-803 - IV 6 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 4: N-803 - IV 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

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 1: N-803 - IV 1 ug/kg3
Cohort 2: N-803 - IV 3 ug/kg2
Cohort 3: N-803 - IV 6 ug/kg2
Cohort 4: N-803 - IV 10 ug/kg3

Reported measurements

Source class 1
Values in mL/kg · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1: N-803 - IV 1 ug/kg126Not reported101159Not reported
Cohort 2: N-803 - IV 3 ug/kg71.8Not reported65.977.8Not reported
Cohort 3: N-803 - IV 6 ug/kg34.0Not reported30.237.8Not reported
Cohort 4: N-803 - IV 10 ug/kg62.8Not reported39.078.0Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        101
        upper Limit
        159
        value
        126
      2. group Id
        OG001
        lower Limit
        65.9
        upper Limit
        77.8
        value
        71.8
      3. group Id
        OG002
        lower Limit
        30.2
        upper Limit
        37.8
        value
        34.0
      4. group Id
        OG003
        lower Limit
        39.0
        upper Limit
        78.0
        value
        62.8
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      2
    3. group Id
      OG002
      value
      2
    4. group Id
      OG003
      value
      3
    units
    Participants
description
Vss Volume of distribution at steady state is a ratio of the total amount of drug in the body to the plasma concentration of the drugs such that Vd = amount of drug in body/plasma drug concentration
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 1: N-803 - IV 1 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 2: N-803 - IV 3 ug/kg
  3. 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
  4. 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
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 - Vss Volume of Distribution at Steady State
type
SECONDARY
unit Of Measure
mL/kg

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

Preserved source evidence · Not medical advice