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NCT01102426 · OUTCOME

Duration of Response (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 the date of first documentation of response to the date of disease progression or death, assessed up to 5 years

What was measured

DR was calculated from the date of first documentation of response to the date of disease progression or death. 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

Analysis population: Patients with documentation of response

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+Dexamethasone51
Dexamethasone1

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Plitidepsin+Dexamethasone5.1Not reported3.26.2Not reported
Dexamethasone0.9Not reportedNANAnot reached

Source statistical analyses

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

  1. ci Lower Limit
    0.004
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.479
    group Description
    Pre-specified
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0001
    p Value Comment
    Cox regression HR: 0.0105
    param Type
    Hazard Ratio (HR)
    param Value
    0.043
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.004
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.479
    group Description
    Pre-specified
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0001
    p Value Comment
    Cox regression HR: 0.0105
    param Type
    Hazard Ratio (HR)
    param Value
    0.043
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.2
        upper Limit
        6.2
        value
        5.1
      2. comment
        not reached
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        0.9
denoms
  1. counts
    1. group Id
      OG000
      value
      51
    2. group Id
      OG001
      value
      1
    units
    Participants
description
DR was calculated from the date of first documentation of response to the date of disease progression or death. 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
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
Patients with documentation of response
reporting Status
POSTED
time Frame
From the date of first documentation of response to the date of disease progression or death, assessed up to 5 years
title
Duration of Response (Investigator Assessment)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice