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NCT00999830 · OUTCOME

Rate of Patients Achieving a Response Based on M-protein or Free Light Chains

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
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices

What was measured

Response was defined: * In patients with a serum M-protein \> 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval; * In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis * In patients with serum M-protein \< 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (\<0.26 or \> 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels.

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 participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Arm A: IPH2101 0.2mg/Kg0Not reportedNot reportedNot reportedNot reported
Arm B: IPH2101 2mg/kg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      14
    2. group Id
      OG001
      value
      13
    units
    Participants
description
Response was defined: * In patients with a serum M-protein \> 5 g/l, as a reduction of at least 25% (minor response according to European society for Blood and Marrow Transplantation (EBMT)) from baseline of serum M-protein confirmed on two consecutive determinations at 4 weeks interval; * In patients with a serum M-protein ≤ 5 g/l and ≥ 3g/l, as a negative electrophoresis * In patients with serum M-protein \< 3 g/l but a measurable involved serum free light chains ≥ 100 mg/l and an abnormal Free Light Chains ratio (\<0.26 or \> 1.65), as a ≥ 50 % decrease in the difference between involved and uninvolved Free Light Chains levels.
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
NUMBER
reporting Status
POSTED
time Frame
From the start of the treatment to the End of Study and during the post study follow up during 2 years according to standard practices
title
Rate of Patients Achieving a Response Based on M-protein or Free Light Chains
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice