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NCT02548962 · OUTCOME

Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment

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 overall response rate, defined as the proportion of subjects achieving a best overall response of PR 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)3Not reportedNot reportedNot reportedNot reported
Phase 1: Dose Finding (840mg)1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    2. group Id
      OG001
      value
      3
    units
    Participants
description
The overall response rate, defined as the proportion of subjects achieving a best overall response of PR 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
Overall Response Rate (ORR) According to the IMWG Response Criteria Per Investigator Assessment
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice