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NCT02100657 · OUTCOME

Event-free Survival

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the date of first infusion to the date of documented PD or death, up to 4 years

What was measured

Event-free survival (EFS) was calculated from the date of first infusion to the date of documented PD or death, but could include additional events besides death and PD that were considered of importance

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

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Plitidepsin (4 mg/m2)+BTZ (1 mg/m2)+DXM (40 mg)10.4Not reported1.827.6Not reported
Plitidepsin (4 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)13.6Not reported3.715.3Not reported
Plitidepsin (5 mg/m2)+BTZ (1.3 mg/m2)+DXM (40 mg)2.8Not reported1.24.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.8
        upper Limit
        27.6
        value
        10.4
      2. group Id
        OG001
        lower Limit
        3.7
        upper Limit
        15.3
        value
        13.6
      3. group Id
        OG002
        lower Limit
        1.2
        upper Limit
        4.8
        value
        2.8
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      18
    units
    Participants
description
Event-free survival (EFS) was calculated from the date of first infusion to the date of documented PD or death, but could include additional events besides death and PD that were considered of importance
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
MEDIAN
reporting Status
POSTED
time Frame
From the date of first infusion to the date of documented PD or death, up to 4 years
title
Event-free Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice