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NCT02548962 · OUTCOME

Clinical Benefit Response (CBR)

Study of Ibrutinib in Combination With Pomalidomide and Dexamethasone in Subjects With Relapsed/Refractory Multiple Myeloma · Source last updated 2019-11-21

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
14 Months

What was measured

The clinical benefit response, defined as the proportion of subjects achieving a best overall response of MR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy.

Groups in this outcome

Phase 1: Dose Finding (560mg)

Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO Ibrutinib (560mg) Pomalidomide (4mg) Dexamethasone (40mg)

Phase 1: Dose Finding (840mg)

Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO Ibrutinib (840mg) Pomalidomide (4mg) Dexamethasone (40mg)

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

Analysis denominator · Participants

GroupSource count
Phase 1: Dose Finding (560mg)8
Phase 1: Dose Finding (840mg)3

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1: Dose Finding (560mg)4Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Finding (840mg)2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        2
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      3
    units
    Participants
description
The clinical benefit response, defined as the proportion of subjects achieving a best overall response of MR or better per investigator assessment per IMWG at or prior to initiation of subsequent anticancer therapy.
groups
  1. description
    Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO Ibrutinib (560mg) Pomalidomide (4mg) Dexamethasone (40mg)
    id
    OG000
    title
    Phase 1: Dose Finding (560mg)
  2. description
    Ibrutinib PO+ Pomalidomide PO+ Dexamethasone PO Ibrutinib (840mg) Pomalidomide (4mg) Dexamethasone (40mg)
    id
    OG001
    title
    Phase 1: Dose Finding (840mg)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
14 Months
title
Clinical Benefit Response (CBR)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice