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NCT01478581 · OUTCOME

The Clinical Benefit Response (CBR)

Study of the Bruton's Tyrosine Kinase Inhibitor in Subjects With Relapsed or Relapsed and Refractory Multiple Myeloma · Source last updated 2020-03-10

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
From the date of first study treatment until disease progression per IMWG, up to 60 months

What was measured

The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria

Analysis population: All treated population

Groups in this outcome

Cohort 1

PCI-32765 420 mg per day PCI-32765

Cohort 2

PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone

Cohort 3

PCI-32765 840 mg per day PCI-32765

Cohort 4

PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 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 113
Cohort 218
Cohort 318
Cohort 443

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 11Not reportedNot reportedNot reportedNot reported
Cohort 21Not reportedNot reportedNot reportedNot reported
Cohort 30Not reportedNot reportedNot reportedNot reported
Cohort 412Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        12
denoms
  1. counts
    1. group Id
      OG000
      value
      13
    2. group Id
      OG001
      value
      18
    3. group Id
      OG002
      value
      18
    4. group Id
      OG003
      value
      43
    units
    Participants
description
The clinical benefit response (CBR) rate, defined as the proportion of subjects who achieved stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), or minimal response (MR) as assessed by the modified International Myeloma Working Group (IMWG) response criteria
groups
  1. description
    PCI-32765 420 mg per day PCI-32765
    id
    OG000
    title
    Cohort 1
  2. description
    PCI-32765 560 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    OG001
    title
    Cohort 2
  3. description
    PCI-32765 840 mg per day PCI-32765
    id
    OG002
    title
    Cohort 3
  4. description
    PCI-32765 840 mg per day, 40 mg dexamethasone (oral) once per week PCI-32765 Dexamethasone
    id
    OG003
    title
    Cohort 4
param Type
COUNT_OF_PARTICIPANTS
population Description
All treated population
reporting Status
POSTED
time Frame
From the date of first study treatment until disease progression per IMWG, up to 60 months
title
The Clinical Benefit Response (CBR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice