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NCT01421186 · OUTCOME

Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202

A Phase 1/2a Study of Human Anti-CD 38 Antibody MOR03087 (MOR202) in Relapsed/Refractory Multiple Myeloma · Source last updated 2021-11-16

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

Measure
MEAN
Unit
µg/mL
Interval / dispersion
Standard Deviation
Time frame
up to 7 days after last MOR202 dose

What was measured

PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups

Analysis population: Pharmakokinetics was analysed on all available data on patients receiving 4mg/kg weekly, 8mg/kg weekly and 16 mg/kg weekly irrespective in which part the patients were treated.

Groups in this outcome

4 mg/kg QW

Dosing at 4 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)

8 mg/kg QW

Dosing at 8 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)

16 mg/kg QW

Dosing at 16 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)

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

Analysis denominator · Participants

GroupSource count
4 mg/kg QW4
8 mg/kg QW14
16 mg/kg QW39

Reported measurements

Source class 1
Values in µg/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
4 mg/kg QW137.8679.43Not reportedNot reportedNot reported
8 mg/kg QW311.67118.33Not reportedNot reportedNot reported
16 mg/kg QW681.53226.69Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        79.43
        value
        137.86
      2. group Id
        OG001
        spread
        118.33
        value
        311.67
      3. group Id
        OG002
        spread
        226.69
        value
        681.53
denoms
  1. counts
    1. group Id
      OG000
      value
      4
    2. group Id
      OG001
      value
      14
    3. group Id
      OG002
      value
      39
    units
    Participants
description
PK analysis for MOR202 4, 8 and 16 mg/kg IV once weekly dose groups only, since serum concentrations of MOR202 were substantially affected by target mediated drug disposition effects for remaining dose groups
dispersion Type
Standard Deviation
groups
  1. description
    Dosing at 4 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
    id
    OG000
    title
    4 mg/kg QW
  2. description
    Dosing at 8 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
    id
    OG001
    title
    8 mg/kg QW
  3. description
    Dosing at 16 mg/kg IV once weekly (incl. one add. dose on Cycle 1 Day 4)
    id
    OG002
    title
    16 mg/kg QW
param Type
MEAN
population Description
Pharmakokinetics was analysed on all available data on patients receiving 4mg/kg weekly, 8mg/kg weekly and 16 mg/kg weekly irrespective in which part the patients were treated.
reporting Status
POSTED
time Frame
up to 7 days after last MOR202 dose
title
Pharmacokinetics: Cmax - Maximum Observed Serum Concentration for MOR202
type
SECONDARY
unit Of Measure
µg/mL

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

Preserved source evidence · Not medical advice