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NCT01962792 · OUTCOME

Overall Response Rate (ORR)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
up to 4 years

What was measured

-To evaluate the overall response (ORR) of ibrutinib in combination with carfilzomib and dexamethasone.

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 Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1 (560 mg)2Not reportedNot reportedNot reportedNot reported
Cohort 2a (560 mg)2Not reportedNot reportedNot reportedNot reported
Cohort 2b (560 mg)12Not reportedNot reportedNot reportedNot reported
All RP2D (840 mg)42Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        12
      4. group Id
        OG003
        value
        42
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
-To evaluate the overall response (ORR) of ibrutinib in combination with carfilzomib and dexamethasone.
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
COUNT_OF_PARTICIPANTS
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
Overall Response Rate (ORR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice