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NCT01496118 · OUTCOME

Overall-survival (OS)

Study of the Combination of Panobinostat and Carfilzomib in Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2022-02-02

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 6 years

What was measured

Measured from time of first study treatment until date of death or date last known alive.

Analysis population: All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.

Groups in this outcome

Dose Level 4 - Escalation and Expansion

Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19

Dose Level 6 - Escalation and Expansion

Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19

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

Analysis denominator · Participants

GroupSource count
Dose Level 4 - Escalation and Expansion31
Dose Level 6 - Escalation and Expansion32

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 4 - Escalation and Expansion29.2Not reported2250.4Not reported
Dose Level 6 - Escalation and Expansion44.6Not reported20.8NAUpper confidence limit is not estimable by Kaplan Meier method due to insufficient observed events
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        22
        upper Limit
        50.4
        value
        29.2
      2. comment
        Upper confidence limit is not estimable by Kaplan Meier method due to insufficient observed events
        group Id
        OG001
        lower Limit
        20.8
        upper Limit
        NA
        value
        44.6
denoms
  1. counts
    1. group Id
      OG000
      value
      31
    2. group Id
      OG001
      value
      32
    units
    Participants
description
Measured from time of first study treatment until date of death or date last known alive.
dispersion Type
95% Confidence Interval
groups
  1. description
    Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 45 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 45 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 30 mg D 1, 3, 5, 15, 17, 19
    id
    OG000
    title
    Dose Level 4 - Escalation and Expansion
  2. description
    Carfilzomib : cycle 1 - 20 mg/m\^2 IV D1, 2 ; 56 mg/m\^2 IV D 8, 9, 15, 16 cycle 2 to progression - 56 mg/m\^2 IV D 1, 2, 8, 9, 15, 16 Panobinostat : cycle 1 and cycle 2 to progression - 20 mg D 1, 3, 5, 15, 17, 19
    id
    OG001
    title
    Dose Level 6 - Escalation and Expansion
param Type
MEDIAN
population Description
All patients receiving dose level 4 and dose level 6 doses (both escalation and expansion phases combined) who had a post-baseline disease assessment per protocol were included in the analysis. 3 patients in dose level 4 and 1 patient in dose level 6 did not have a post-baseline assessment and were excluded from analysis.
reporting Status
POSTED
time Frame
up to 6 years
title
Overall-survival (OS)
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice