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NCT01222286 · OUTCOME

Rate of Patients Achieving an Objective Response

Study on the Anti-tumor Activity, Safety and Pharmacology of IPH2101 in Patients With Smoldering Multiple Myeloma · Source last updated 2026-05-14

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 start to end of study (14 months)

What was measured

The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.

Analysis population: The ITT population included all randomized subjects.

Groups in this outcome

IPH2101 0.2 mg/kg

0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles

IPH2101 2 mg/kg

2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 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
IPH2101 0.2 mg/kg16
IPH2101 2 mg/kg14

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IPH2101 0.2 mg/kg0Not reportedNot reportedNot reportedNot reported
IPH2101 2 mg/kg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      14
    units
    Participants
description
The primary end point is the rate of patients achieving an objective response (defined according to the International Myeloma Working Group uniform response criteria), including minimal response, (as derived from the European Society for Blood and Marrow Transplantation criteria), achieved at any time until end of study and confirmed on two consecutive assessments at 4 weeks interval.
groups
  1. description
    0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
    id
    OG000
    title
    IPH2101 0.2 mg/kg
  2. description
    2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
    id
    OG001
    title
    IPH2101 2 mg/kg
param Type
NUMBER
population Description
The ITT population included all randomized subjects.
reporting Status
POSTED
time Frame
from start to end of study (14 months)
title
Rate of Patients Achieving an Objective Response
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice