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NCT02654990 · OUTCOME

Exposure Response: Cmax for Panobinostat

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
NUMBER
Unit
percent probability
Interval / dispersion
95% Confidence Interval
Time frame
Up to 5.2 Years

What was measured

The exposure-response relationship was assessed utilizing Cmax (Cycle 1 Day 1) for panobinostat versus the outcomes of ORR, grade 3/4 thrombocytopenia, and grade 3/4 diarrhea. Two statistical models were used: logistic regression models, in which these 3 outcomes were treated in a binary fashion according to their occurrence; Cox regression models, with the relevant outcomes being the time to occurrence of grade 3/4 thrombocytopenia and the time to occurrence of grade 3/4 diarrhea. Results are reported as model-based probability. An increase in the model-based probability indicates an increase in the occurrence of the outcomes (ORR, grade 3/4 thrombocytopenia, 3/4 diarrhea) with increasing values of Cmax (that is, with increasing dose of panobinostat).

Analysis population: Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.

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)18
Arm B - Panobinostat (20 mg, BIW)20
Arm C - Panobinostat (10 mg, TIW)18

Reported measurements

ORR by IRC (up to 8 cycles)

Analysis denominator · Participants

GroupSource count
Arm A - Panobinostat (20 mg, TIW)18
Arm B - Panobinostat (20 mg, BIW)19
Arm C - Panobinostat (10 mg, TIW)17
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A - Panobinostat (20 mg, TIW)63.1Not reported46.776.9Not reported
Arm B - Panobinostat (20 mg, BIW)62.2Not reported47.575.0Not reported
Arm C - Panobinostat (10 mg, TIW)35.3Not reported20.653.4Not reported
Grade 3/4 Thrombocytopenia

Analysis denominator · Participants

GroupSource count
Arm A - Panobinostat (20 mg, TIW)18
Arm B - Panobinostat (20 mg, BIW)20
Arm C - Panobinostat (10 mg, TIW)17
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A - Panobinostat (20 mg, TIW)32.2Not reported17.751.2Not reported
Arm B - Panobinostat (20 mg, BIW)28.7Not reported17.543.4Not reported
Arm C - Panobinostat (10 mg, TIW)21.7Not reported10.639.4Not reported
Grade 3/4 Diarrhea

Analysis denominator · Participants

GroupSource count
Arm A - Panobinostat (20 mg, TIW)18
Arm B - Panobinostat (20 mg, BIW)20
Arm C - Panobinostat (10 mg, TIW)18
Values in percent probability · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A - Panobinostat (20 mg, TIW)6.2Not reported2.116.7Not reported
Arm B - Panobinostat (20 mg, BIW)7.5Not reported3.117.2Not reported
Arm C - Panobinostat (10 mg, TIW)2.5Not reported0.316.3Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        46.7
        upper Limit
        76.9
        value
        63.1
      2. group Id
        OG001
        lower Limit
        47.5
        upper Limit
        75.0
        value
        62.2
      3. group Id
        OG002
        lower Limit
        20.6
        upper Limit
        53.4
        value
        35.3
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        19
      3. group Id
        OG002
        value
        17
      units
      Participants
    title
    ORR by IRC (up to 8 cycles)
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        17.7
        upper Limit
        51.2
        value
        32.2
      2. group Id
        OG001
        lower Limit
        17.5
        upper Limit
        43.4
        value
        28.7
      3. group Id
        OG002
        lower Limit
        10.6
        upper Limit
        39.4
        value
        21.7
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        17
      units
      Participants
    title
    Grade 3/4 Thrombocytopenia
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.1
        upper Limit
        16.7
        value
        6.2
      2. group Id
        OG001
        lower Limit
        3.1
        upper Limit
        17.2
        value
        7.5
      3. group Id
        OG002
        lower Limit
        0.3
        upper Limit
        16.3
        value
        2.5
    denoms
    1. counts
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        20
      3. group Id
        OG002
        value
        18
      units
      Participants
    title
    Grade 3/4 Diarrhea
denoms
  1. counts
    1. group Id
      OG000
      value
      18
    2. group Id
      OG001
      value
      20
    3. group Id
      OG002
      value
      18
    units
    Participants
description
The exposure-response relationship was assessed utilizing Cmax (Cycle 1 Day 1) for panobinostat versus the outcomes of ORR, grade 3/4 thrombocytopenia, and grade 3/4 diarrhea. Two statistical models were used: logistic regression models, in which these 3 outcomes were treated in a binary fashion according to their occurrence; Cox regression models, with the relevant outcomes being the time to occurrence of grade 3/4 thrombocytopenia and the time to occurrence of grade 3/4 diarrhea. Results are reported as model-based probability. An increase in the model-based probability indicates an increase in the occurrence of the outcomes (ORR, grade 3/4 thrombocytopenia, 3/4 diarrhea) with increasing values of Cmax (that is, with increasing dose of panobinostat).
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
NUMBER
population Description
Full analysis set (FAS): all participants to whom study treatment was assigned by randomization. Here, 'Overall Number of Participants Analyzed' refers to the number of evaluable participants analyzed.
reporting Status
POSTED
time Frame
Up to 5.2 Years
title
Exposure Response: Cmax for Panobinostat
type
SECONDARY
unit Of Measure
percent probability

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

Preserved source evidence · Not medical advice