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NCT01222286 · OUTCOME

Secondary Anti-tumor Activity

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
Participant
Interval / dispersion
Not reported
Time frame
from start to end of study (14 months)

What was measured

* any change of M-protein in serum occurring during the study (\>25 percentage increase in level of serum M-protein) * progression to active Multiple Myeloma Definition of active Multiple Myeloma: Evidence of progression based on the IMWG criteria for progressive disease in myeloma and any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder : * Development of new soft tissue plasmacytomas or bone lesions * Hypercalcemia (\> 11mg/100ml) * Decrease in hemoglobin of \> 2g/100ml * Rise in serum creatinine by 2 mg/100ml or more

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

serum M-protein progression
Values in Participant · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IPH2101 0.2 mg/kg4Not reportedNot reportedNot reportedNot reported
IPH2101 2 mg/kg8Not reportedNot reportedNot reportedNot reported
Progression to active Multiple Myeloma
Values in Participant · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
IPH2101 0.2 mg/kg2Not reportedNot reportedNot reportedNot reported
IPH2101 2 mg/kg3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        8
    title
    serum M-protein progression
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
    title
    Progression to active Multiple Myeloma
denoms
  1. counts
    1. group Id
      OG000
      value
      16
    2. group Id
      OG001
      value
      14
    units
    Participants
description
* any change of M-protein in serum occurring during the study (\>25 percentage increase in level of serum M-protein) * progression to active Multiple Myeloma Definition of active Multiple Myeloma: Evidence of progression based on the IMWG criteria for progressive disease in myeloma and any one or more of the following felt related to the underlying clonal plasma cell proliferative disorder : * Development of new soft tissue plasmacytomas or bone lesions * Hypercalcemia (\> 11mg/100ml) * Decrease in hemoglobin of \> 2g/100ml * Rise in serum creatinine by 2 mg/100ml or more
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
reporting Status
POSTED
time Frame
from start to end of study (14 months)
title
Secondary Anti-tumor Activity
type
SECONDARY
unit Of Measure
Participant

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

Preserved source evidence · Not medical advice