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NCT01102426 · OUTCOME

Progression-free Survival (Investigator Assessment)

Aplidin - Dexamethasone in Relapsed/Refractory Myeloma · Source last updated 2020-11-10

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

Measure
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years

What was measured

The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.

Analysis population: All Randomized Patients

Groups in this outcome

Plitidepsin+Dexamethasone

plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.

Dexamethasone

dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.

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

Analysis denominator · Participants

GroupSource count
Plitidepsin+Dexamethasone171
Dexamethasone84

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Plitidepsin+Dexamethasone2.9Not reported2.13.7Not reported
Dexamethasone1.1Not reported1.01.9Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.382
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.686
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    p Value Comment
    Cox regression HR: p\<0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.512
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.382
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.686
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    < 0.0001
    p Value Comment
    Cox regression HR: p\<0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.512
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        3.7
        value
        2.9
      2. group Id
        OG001
        lower Limit
        1.0
        upper Limit
        1.9
        value
        1.1
denoms
  1. counts
    1. group Id
      OG000
      value
      171
    2. group Id
      OG001
      value
      84
    units
    Participants
description
The secondary study analysis was based on Investigator's assessment PFS data in the ITT efficacy population, defined as all patients randomized to either treatment arm. PFS was calculated from randomization to the first evidence of PD or death due to any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions If the patient received further antitumor therapy before PD and within the timeframe expected for first follow-up, PFS was censored on the date of the last disease assessment prior to the administration of this antitumor therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    plitidepsin + dexamethasone combination plitidepsin + dexamethasone: plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
    id
    OG000
    title
    Plitidepsin+Dexamethasone
  2. description
    dexamethasone single agent dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
    id
    OG001
    title
    Dexamethasone
param Type
MEDIAN
population Description
All Randomized Patients
reporting Status
POSTED
time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 5 years
title
Progression-free Survival (Investigator Assessment)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice