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NCT02654990 · OUTCOME

Progression-free Survival (PFS)

Panobinostat/Bortezomib/Dexamethasone in Relapsed or Relapsed-and-refractory Multiple Myeloma · Source last updated 2024-07-12

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
Up to 5.2 years

What was measured

PFS, assessed based on IMWG criteria per blind IRC assessment, is defined as the time from date of randomization to date of first documented disease progression or death (regardless of cause of death).

Analysis population: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.

Groups in this outcome

Arm A - Panobinostat (20 mg, TIW)

Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

Arm B - Panobinostat (20 mg, BIW)

Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

Arm C - Panobinostat (10 mg, TIW)

Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Arm A - Panobinostat (20 mg, TIW)82
Arm B - Panobinostat (20 mg, BIW)83
Arm C - Panobinostat (10 mg, TIW)83

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A - Panobinostat (20 mg, TIW)15Not reported7.424.7Not reported
Arm B - Panobinostat (20 mg, BIW)13Not reported7.013.8Not reported
Arm C - Panobinostat (10 mg, TIW)8Not reported5.010.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.4
        upper Limit
        24.7
        value
        15
      2. group Id
        OG001
        lower Limit
        7.0
        upper Limit
        13.8
        value
        13
      3. group Id
        OG002
        lower Limit
        5.0
        upper Limit
        10.7
        value
        8
denoms
  1. counts
    1. group Id
      OG000
      value
      82
    2. group Id
      OG001
      value
      83
    3. group Id
      OG002
      value
      83
    units
    Participants
description
PFS, assessed based on IMWG criteria per blind IRC assessment, is defined as the time from date of randomization to date of first documented disease progression or death (regardless of cause of death).
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 20 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    OG000
    title
    Arm A - Panobinostat (20 mg, TIW)
  2. description
    Participants received 20 mg panobinostat BIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    OG001
    title
    Arm B - Panobinostat (20 mg, BIW)
  3. description
    Participants received 10 mg panobinostat TIW, 2 weeks on/1 week off in combination with subcutaneous bortezomib and oral dexamethasone.
    id
    OG002
    title
    Arm C - Panobinostat (10 mg, TIW)
param Type
MEDIAN
population Description
Full analysis set (FAS): all participants to whom study treatment was assigned by randomization.
reporting Status
POSTED
time Frame
Up to 5.2 years
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice