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NCT01222286 · FLOW

Participant flow

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.

groups
  1. description
    0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
    id
    FG000
    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
    FG001
    title
    IPH2101 2 mg/kg
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        14
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        14
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
All patients enrolled were screened in order to verify the inclusion/exclusion criteria. All patients enrolled (30 patients) were analyzed.
recruitment Details
There were 44 patients screened, 14 subjects were not randomized, 12 of whom were screen failures, 30 patients randomized.
Complete source fields
groups
  1. description
    0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
    id
    FG000
    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
    FG001
    title
    IPH2101 2 mg/kg
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        14
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        16
      2. group Id
        FG001
        num Subjects
        14
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
All patients enrolled were screened in order to verify the inclusion/exclusion criteria. All patients enrolled (30 patients) were analyzed.
recruitment Details
There were 44 patients screened, 14 subjects were not randomized, 12 of whom were screen failures, 30 patients randomized.

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Preserved source evidence · Not medical advice