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NCT02100657 · OUTCOME

Time to Progression Rates

Study of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Patients With Multiple Myeloma · Source last updated 2020-10-12

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

Measure
MEAN
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years

What was measured

Time to progression (TTP) was calculated from the date of the first infusion to the date of documented PD or death due to PD.

Groups in this outcome

Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)

Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles

Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)

Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles

Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)

Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles

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 (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)7
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)3
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)18

Reported measurements

At 3 months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)85.7Not reported59.8100.0Not reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)100.0Not reported100.0100.0Not reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)44.4Not reported21.567.4Not reported
At 6 months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)71.4Not reported38.0100.0Not reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)66.7Not reported13.3100.0Not reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)26.7Not reported5.747.6Not reported
At 12 months
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)35.7Not reported0.074.5Not reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)66.7Not reported13.3100.0Not reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)13.3Not reported0.030.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        59.8
        upper Limit
        100.0
        value
        85.7
      2. group Id
        OG001
        lower Limit
        100.0
        upper Limit
        100.0
        value
        100.0
      3. group Id
        OG002
        lower Limit
        21.5
        upper Limit
        67.4
        value
        44.4
    title
    At 3 months
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        38.0
        upper Limit
        100.0
        value
        71.4
      2. group Id
        OG001
        lower Limit
        13.3
        upper Limit
        100.0
        value
        66.7
      3. group Id
        OG002
        lower Limit
        5.7
        upper Limit
        47.6
        value
        26.7
    title
    At 6 months
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        74.5
        value
        35.7
      2. group Id
        OG001
        lower Limit
        13.3
        upper Limit
        100.0
        value
        66.7
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        30.1
        value
        13.3
    title
    At 12 months
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      18
    units
    Participants
description
Time to progression (TTP) was calculated from the date of the first infusion to the date of documented PD or death due to PD.
dispersion Type
95% Confidence Interval
groups
  1. description
    Patients received plitidepsin 4 mg/m2 and BTZ 1 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    OG000
    title
    Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)
  2. description
    Patients received plitidepsin 4 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    OG001
    title
    Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)
  3. description
    Patients received plitidepsin 5 mg/m2 and BTZ 1.3 mg/m2 and DXM 40 mg. DXM was administered at least one hour before the start of plitidepsin infusion, and BTZ was administered one minute after the end of the plitidepsin infusion. Patients received a maximum of eight treatment cycles
    id
    OG002
    title
    Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)
param Type
MEAN
reporting Status
POSTED
time Frame
From the date of the first infusion to the date of documented PD or death due to PD, up to 4 years
title
Time to Progression Rates
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice