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NCT01962792 · OUTCOME

Duration of Response (DOR)

Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma · Source last updated 2021-12-21

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 4 years

What was measured

The time interval between the date of initial documentation of a response (PR or better) and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects who had not progressed/died. The censoring date was the last adequate tumor assessment date.

Analysis population: Please note that the analysis only includes participants who achieved the best response of complete response or partial response from the All-treated population (per protocol).

Groups in this outcome

Cohort 1 (560 mg)

Ibrutinib PO 560 mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib

Cohort 2a (560 mg)

Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib

Cohort 2b (560 mg)

Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone

All RP2D (840 mg)

Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg Ibrutinib Carfilzomib 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
Cohort 1 (560 mg)3
Cohort 2a (560 mg)5
Cohort 2b (560 mg)17
All RP2D (840 mg)59

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1 (560 mg)7.1Not reported1.213.0Not reported
Cohort 2a (560 mg)15.3Not reported5.415.3Not reported
Cohort 2b (560 mg)9.2Not reported3.014.5Not reported
All RP2D (840 mg)7.2Not reported2.716.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.2
        upper Limit
        13.0
        value
        7.1
      2. group Id
        OG001
        lower Limit
        5.4
        upper Limit
        15.3
        value
        15.3
      3. group Id
        OG002
        lower Limit
        3.0
        upper Limit
        14.5
        value
        9.2
      4. group Id
        OG003
        lower Limit
        2.7
        upper Limit
        16.6
        value
        7.2
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      5
    3. group Id
      OG002
      value
      17
    4. group Id
      OG003
      value
      59
    units
    Participants
description
The time interval between the date of initial documentation of a response (PR or better) and the date of first documented evidence of progressive disease, death, or date of censoring for the subjects who had not progressed/died. The censoring date was the last adequate tumor assessment date.
dispersion Type
95% Confidence Interval
groups
  1. description
    Ibrutinib PO 560 mg + Carfilzomib IV 20/27 mg/m2 Ibrutinib Carfilzomib
    id
    OG000
    title
    Cohort 1 (560 mg)
  2. description
    Ibrutinib PO 560 mg + Carfilzomib IV 20/36 mg/m2 Ibrutinib Carfilzomib
    id
    OG001
    title
    Cohort 2a (560 mg)
  3. description
    Ibrutinib PO 560 mg+ Carfilzomib IV 20/36 mg/m2 Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    OG002
    title
    Cohort 2b (560 mg)
  4. description
    Ibrutinib PO 840 mg + Carfilzomib IV 20/36 mg/m2 + Dexamethasone PO 20 mg Ibrutinib Carfilzomib Dexamethasone
    id
    OG003
    title
    All RP2D (840 mg)
param Type
MEDIAN
population Description
Please note that the analysis only includes participants who achieved the best response of complete response or partial response from the All-treated population (per protocol).
reporting Status
POSTED
time Frame
Up to 4 years
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice