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NCT00229203 · OUTCOME

Progression Free Survival (PFS)

A Study of Aplidin (Plitidepsin) 3 h iv in Subjects With Relapsing or Refractory Multiple Myeloma · Source last updated 2009-12-24

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
Full Range
Time frame
Every 2 weeks until progression or death occurs. Median PFS and PFS rates at 3 months and 6 months were assessed.

What was measured

Progression Free Survival (PFS): time from the date of first infusion to the date of documented progression or death

Analysis population: Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients)

Groups in this outcome

Plitidepsin

Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.

Plitidepsin + Dexamethasone

Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Plitidepsin21
Plitidepsin + Dexamethasone8

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Plitidepsin2.3Not reported1.42.6Not reported
Plitidepsin + Dexamethasone3.8Not reported3.17.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.4
        upper Limit
        2.6
        value
        2.3
      2. group Id
        OG001
        lower Limit
        3.1
        upper Limit
        7.7
        value
        3.8
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      8
    units
    Participants
description
Progression Free Survival (PFS): time from the date of first infusion to the date of documented progression or death
dispersion Type
Full Range
groups
  1. description
    Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
    id
    OG000
    title
    Plitidepsin
  2. description
    Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
    id
    OG001
    title
    Plitidepsin + Dexamethasone
param Type
MEDIAN
population Description
Per protocol - Only 21 of 32 and 8 of 19 enrolled patients were evaluable (analyzed patients)
reporting Status
POSTED
time Frame
Every 2 weeks until progression or death occurs. Median PFS and PFS rates at 3 months and 6 months were assessed.
title
Progression Free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice