Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03702725 · OUTCOME

Number of Participants With Dose Limiting Toxicities

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
During cycle 1 (28-day cycle)

What was measured

DLTs were grade 4 thrombocytopenia; grade 4 neutropenia lasting \> 5 days or febrile neutropenia; grade 3 thrombocytopenia with bleeding or platelet transfusion; grade 3-4 hyperglycemia or a thrombotic/embolic event; or grade 3-4 non-hematologic toxicity (except grade 3 nausea, diarrhea, and vomiting), that were at least probably related to treatment, treatment delays ≥ 21 days for toxicity, and treatment-related death.

Analysis population: Eligible patients who started protocol treatment were excluded from the determination of MTD if they failed to completed one cycle of treatments for reasons other than toxicity. Specifically. two patient assigned to DL3 were excluded from MTD determination: one developed COVID-19 infection and the other received 280 mg/day of IBR instead of the assigned 840 mg/day dose during cycle 1.

Groups in this outcome

Dose Level 1 (Starting DL)

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 DL)6
Dose Level 23
Dose Level 32

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Dose Level 1 (Starting DL)1Not reportedNot reportedNot reportedNot reported
Dose Level 20Not reportedNot reportedNot reportedNot reported
Dose Level 30Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    OTHER
    other Analysis Description
    Estimate value DL 3
Complete source fields
analyses
  1. group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    OTHER
    other Analysis Description
    Estimate value DL 3
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      2
    units
    Participants
description
DLTs were grade 4 thrombocytopenia; grade 4 neutropenia lasting \> 5 days or febrile neutropenia; grade 3 thrombocytopenia with bleeding or platelet transfusion; grade 3-4 hyperglycemia or a thrombotic/embolic event; or grade 3-4 non-hematologic toxicity (except grade 3 nausea, diarrhea, and vomiting), that were at least probably related to treatment, treatment delays ≥ 21 days for toxicity, and treatment-related death.
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 DL)
  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
Eligible patients who started protocol treatment were excluded from the determination of MTD if they failed to completed one cycle of treatments for reasons other than toxicity. Specifically. two patient assigned to DL3 were excluded from MTD determination: one developed COVID-19 infection and the other received 280 mg/day of IBR instead of the assigned 840 mg/day dose during cycle 1.
reporting Status
POSTED
time Frame
During cycle 1 (28-day cycle)
title
Number of Participants With Dose Limiting Toxicities
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice