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NCT03702725 · OUTCOME

Objective Response Rate

Study of Ibrutinib in Combination With Revlimid/Dexamethasone in Relapsed/Refractory Multiple Myeloma · Source last updated 2026-01-06

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
90% Confidence Interval
Time frame
Up to 34 months

What was measured

The objective response rate is the percent of patients who meet the International Myeloma Working Group Response Criteria for sCR, CR, VGPR, or PR on two consecutive evaluations at least 4 weeks apart among the patients who began study treatment. A 90% binomial confidence interval will be constructed for the overall objective response rate.

Groups in this outcome

Dose Level 1 Starting Cohort

Ibrutinib 560 mg on Days 1-28, * Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 * Every 28 days

Dose Level 2

* Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 * Every 28 days Ibrutinib 560 mg on Days 1-28, * Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 * Every 28 days

Dose Level 3

Ibrutinib 840 mg on Days 1-28, * Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 * Every 28 days

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

Analysis denominator · Participants

GroupSource count
Dose Level 1 Starting Cohort6
Dose Level 23
Dose Level 34

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 90% Confidence Interval
GroupValueSpreadLowerUpperComment
Dose Level 1 Starting Cohort16.7Not reported0.958.2Not reported
Dose Level 20Not reported063.2Not reported
Dose Level 325Not reported1.375.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.9
        upper Limit
        58.2
        value
        16.7
      2. group Id
        OG001
        lower Limit
        0
        upper Limit
        63.2
        value
        0
      3. group Id
        OG002
        lower Limit
        1.3
        upper Limit
        75.1
        value
        25
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      4
    units
    Participants
description
The objective response rate is the percent of patients who meet the International Myeloma Working Group Response Criteria for sCR, CR, VGPR, or PR on two consecutive evaluations at least 4 weeks apart among the patients who began study treatment. A 90% binomial confidence interval will be constructed for the overall objective response rate.
dispersion Type
90% Confidence Interval
groups
  1. description
    Ibrutinib 560 mg on Days 1-28, * Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 * Every 28 days
    id
    OG000
    title
    Dose Level 1 Starting Cohort
  2. description
    * Lenalidomide 15 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 * Every 28 days Ibrutinib 560 mg on Days 1-28, * Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 * Every 28 days
    id
    OG001
    title
    Dose Level 2
  3. description
    Ibrutinib 840 mg on Days 1-28, * Lenalidomide 25 mg on Days 1-21 Dexamethasone 40 mg on Days 1,8,15, 22 * Every 28 days
    id
    OG002
    title
    Dose Level 3
param Type
NUMBER
reporting Status
POSTED
time Frame
Up to 34 months
title
Objective Response Rate
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice