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NCT00999830 · OUTCOME

Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment

Evaluation of Activity, Safety and Pharmacology of IPH2101 a Human Monoclonal Antibody in Patients With Multiple Myeloma · Source last updated 2016-03-24

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

Measure
MEDIAN
Unit
% of occupancy
Interval / dispersion
Full Range
Time frame
From the start up to the end of study (15 months)

What was measured

KIR-occupancy is a relative measure of the fraction of cell surface KIR that is occupied by the IPH2101 monoclonal antibody, and hence is unavailable for binding to HLA ligands.

Groups in this outcome

Arm A: IPH2101 0.2mg/Kg

every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.

Arm B: IPH2101 2mg/kg

every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 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
Arm A: IPH2101 0.2mg/Kg14
Arm B: IPH2101 2mg/kg13

Reported measurements

Source class 1
Values in % of occupancy · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Arm A: IPH2101 0.2mg/Kg80.5Not reported33.895Not reported
Arm B: IPH2101 2mg/kg96.8Not reported9399.4Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        33.8
        upper Limit
        95
        value
        80.5
      2. group Id
        OG001
        lower Limit
        93
        upper Limit
        99.4
        value
        96.8
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      13
    units
    Participants
description
KIR-occupancy is a relative measure of the fraction of cell surface KIR that is occupied by the IPH2101 monoclonal antibody, and hence is unavailable for binding to HLA ligands.
dispersion Type
Full Range
groups
  1. description
    every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
    id
    OG000
    title
    Arm A: IPH2101 0.2mg/Kg
  2. description
    every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
    id
    OG001
    title
    Arm B: IPH2101 2mg/kg
param Type
MEDIAN
reporting Status
POSTED
time Frame
From the start up to the end of study (15 months)
title
Biological Activity of IPH2101 on Killer Immunogloblin Like Receptors (KIR) Occupancy at End of Treatment
type
SECONDARY
unit Of Measure
% of occupancy

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

Preserved source evidence · Not medical advice