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NCT00229203 · OUTCOME

Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response

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
NUMBER
Unit
percentage patients
Interval / dispersion
Not reported
Time frame
Every 2 weeks until progression or death occurs.

What was measured

Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: \>25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. Treatmen failure: Reappearance of serum or urinary paraprotein

Analysis population: Per protocol - Only 29 of 32 and 18 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
Plitidepsin29
Plitidepsin + Dexamethasone18

Reported measurements

Complete response
Values in percentage patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin0Not reportedNot reportedNot reportedNot reported
Plitidepsin + Dexamethasone0Not reportedNot reportedNot reportedNot reported
Partial response
Values in percentage patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin3Not reportedNot reportedNot reportedNot reported
Plitidepsin + Dexamethasone11Not reportedNot reportedNot reportedNot reported
Minimal response
Values in percentage patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin7Not reportedNot reportedNot reportedNot reported
Plitidepsin + Dexamethasone11Not reportedNot reportedNot reportedNot reported
Stable Disease/No changes
Values in percentage patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin41Not reportedNot reportedNot reportedNot reported
Plitidepsin + Dexamethasone61Not reportedNot reportedNot reportedNot reported
Progressive Disease/Treatment failure
Values in percentage patients · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Plitidepsin48Not reportedNot reportedNot reportedNot reported
Plitidepsin + Dexamethasone17Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        11
    title
    Partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        11
    title
    Minimal response
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        41
      2. group Id
        OG001
        value
        61
    title
    Stable Disease/No changes
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        17
    title
    Progressive Disease/Treatment failure
denoms
  1. counts
    1. group Id
      OG000
      value
      29
    2. group Id
      OG001
      value
      18
    units
    Participants
description
Complete response(CR):0 percentage the original monoclonal protein level from blood and urine Partial response(PR): ≥50 percentage reduction in the level of serum monoclonal protein Minimal response(MR):≥25 percentage to ≤ 49 percentage reduction in the level of serum monoclonal protein Stable disease: Not meeting the criteria for MR or PD. Progressive disease: \>25 percentage increase in level of serum monoclonal paraprotein, which must also be an absolute increase of at least 5 g/L and confirmed on a repeat investigation. Treatmen failure: Reappearance of serum or urinary paraprotein
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
NUMBER
population Description
Per protocol - Only 29 of 32 and 18 of 19 enrolled patients were evaluable (analyzed patients)
reporting Status
POSTED
time Frame
Every 2 weeks until progression or death occurs.
title
Objective Response Rate (ORR), Defined as the Combined Rate of Complete Response, Partial Response and Minimal Response
type
PRIMARY
unit Of Measure
percentage patients

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

Preserved source evidence · Not medical advice