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NCT01102426 · OUTCOME

Overall Response Rate (Independent Review Committee)

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
NUMBER
Unit
percentage of participants
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

Overall response rate including sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone lesions

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 percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Plitidepsin+Dexamethasone22.8Not reported16.829.8Not reported
Dexamethasone3.6Not reported0.710.1Not reported

Source statistical analyses

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

  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    statistical Method
    Fisher Exact
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.8
        upper Limit
        29.8
        value
        22.8
      2. group Id
        OG001
        lower Limit
        0.7
        upper Limit
        10.1
        value
        3.6
denoms
  1. counts
    1. group Id
      OG000
      value
      171
    2. group Id
      OG001
      value
      84
    units
    Participants
description
Overall response rate including sCR, CR, VGPR, PR and MR. Very good partial response (VGPR) serum and urine M-protein detectable but not electrophoresis or \>90% reduction in serum M-protein and urine M-protein \<100 mg/24h Partial response (PR) ≥50% reduction in serum M-protein and 90% reduction in 24h urine M-protein or to \<200 mg/24h. 50% reduction in size of any soft tissue plasmacytomas Minor response (MR) 25%-49% reduction of serum M-protein and 50-89% reduction of 24h urine M-protein. 25-49% reduction in size of soft tissue plasmacytomas. No increase in size or number of bone 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
NUMBER
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
Overall Response Rate (Independent Review Committee)
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice