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NCT00999830 · FLOW

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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.

groups
  1. description
    IPH2101 Fully human anti-KIR monoclonal antibody : 0.2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
    id
    FG000
    title
    Arm A: IPH2101 0.2mg/Kg
  2. description
    IPH2101 Fully human anti-KIR monoclonal antibody : 2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
    id
    FG001
    title
    Arm B: IPH2101 2mg/kg
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        13
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        13
      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 in the study were analyzed. There was no screen failure during the trial conduct.
recruitment Details
Patients were recruited in France at the public hospital (10 actives center), from mid of November 2009 to end of October 2011.
Complete source fields
groups
  1. description
    IPH2101 Fully human anti-KIR monoclonal antibody : 0.2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
    id
    FG000
    title
    Arm A: IPH2101 0.2mg/Kg
  2. description
    IPH2101 Fully human anti-KIR monoclonal antibody : 2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
    id
    FG001
    title
    Arm B: IPH2101 2mg/kg
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        13
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        14
      2. group Id
        FG001
        num Subjects
        13
      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 in the study were analyzed. There was no screen failure during the trial conduct.
recruitment Details
Patients were recruited in France at the public hospital (10 actives center), from mid of November 2009 to end of October 2011.

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Preserved source evidence · Not medical advice