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NCT03702725 · OUTCOME

Maximum Toxicity Grade

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to 34 month

What was measured

The maximum grade of each type of toxicity will be recorded for each patient. For each toxicity reported by dose level, the percentage of patients developing any degree of that toxicity as well as the percentage of patients developing a severe degree (Grade 3 or higher) will be determined. Adverse Events were graded using CTCAE v4.0.

Analysis population: All eligible patients who began protocol treatment.

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

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

Grade 3
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 Starting Cohort4Not reportedNot reportedNot reportedNot reported
Dose Level 23Not reportedNot reportedNot reportedNot reported
Dose Level 33Not reportedNot reportedNot reportedNot reported
Grade 4
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 Starting Cohort1Not reportedNot reportedNot reportedNot reported
Dose Level 20Not reportedNot reportedNot reportedNot reported
Dose Level 31Not reportedNot reportedNot reportedNot reported
Grade 5
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 Starting Cohort1Not reportedNot reportedNot reportedNot reported
Dose Level 20Not reportedNot reportedNot reportedNot reported
Dose Level 31Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
    title
    Grade 3
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 4
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
    title
    Grade 5
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 maximum grade of each type of toxicity will be recorded for each patient. For each toxicity reported by dose level, the percentage of patients developing any degree of that toxicity as well as the percentage of patients developing a severe degree (Grade 3 or higher) will be determined. Adverse Events were graded using CTCAE v4.0.
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
    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
COUNT_OF_PARTICIPANTS
population Description
All eligible patients who began protocol treatment.
reporting Status
POSTED
time Frame
Up to 34 month
title
Maximum Toxicity Grade
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice