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NCT03773107 · OUTCOME

Dose Limiting Toxicity (DLT)

LCI-HEM-MYE-CRD-004 (MMRC-073 CARJAK): Study of CRD for Carfilzomib-Refractory Multiple Myeloma · Source last updated 2025-01-13

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
28 days

What was measured

DLTs will be determined for each subject as a binary variable indicating whether or not the subject experienced a DLT during Cycle 1

Analysis population: Participants who are DLT evaluable

Groups in this outcome

Phase I 5 mg Ruxolitinib

Cohort 1) 5mg ruxolitinib Carfilzomib: Irreversible proteasome inhibitor Ruxolitinib: Oral JAK inhibitor Dexamethasone: glucocorticoid

Phase I 10 mg Ruxolitinib

Cohort 2) 10mg ruxolitinib Carfilzomib: Irreversible proteasome inhibitor Ruxolitinib: Oral JAK inhibitor Dexamethasone: glucocorticoid

Phase I 15 mg Ruxolitinib

Cohort 3) 15mg ruxolitinib Carfilzomib: Irreversible proteasome inhibitor Ruxolitinib: Oral JAK inhibitor Dexamethasone: glucocorticoid

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 I 5 mg Ruxolitinib3
Phase I 10 mg Ruxolitinib3
Phase I 15 mg Ruxolitinib2

Reported measurements

Source class 1
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase I 5 mg Ruxolitinib0Not reportedNot reportedNot reportedNot reported
Phase I 10 mg Ruxolitinib0Not reportedNot reportedNot reportedNot reported
Phase I 15 mg Ruxolitinib1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      2
    units
    Participants
description
DLTs will be determined for each subject as a binary variable indicating whether or not the subject experienced a DLT during Cycle 1
groups
  1. description
    Cohort 1) 5mg ruxolitinib Carfilzomib: Irreversible proteasome inhibitor Ruxolitinib: Oral JAK inhibitor Dexamethasone: glucocorticoid
    id
    OG000
    title
    Phase I 5 mg Ruxolitinib
  2. description
    Cohort 2) 10mg ruxolitinib Carfilzomib: Irreversible proteasome inhibitor Ruxolitinib: Oral JAK inhibitor Dexamethasone: glucocorticoid
    id
    OG001
    title
    Phase I 10 mg Ruxolitinib
  3. description
    Cohort 3) 15mg ruxolitinib Carfilzomib: Irreversible proteasome inhibitor Ruxolitinib: Oral JAK inhibitor Dexamethasone: glucocorticoid
    id
    OG002
    title
    Phase I 15 mg Ruxolitinib
param Type
NUMBER
population Description
Participants who are DLT evaluable
reporting Status
POSTED
time Frame
28 days
title
Dose Limiting Toxicity (DLT)
type
PRIMARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice