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NCT00985959 · OUTCOME

Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I

A Study of JNJ-26866138 (Bortezomib) in Untreated Multiple Myeloma Patients Who Are Not Candidates for Hematopoietic Stem Cell Transplant (HSCT) · Source last updated 2013-12-02

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

Measure
MEAN
Unit
ng/mL
Interval / dispersion
Standard Deviation
Time frame
Day 25 of Cycle 1

What was measured

Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 1/Day 25 (JNJ-26866138 alone)

Analysis population: Pharmacokinetics-evaluable population: 16 participants were included in pharmacokinetics-evaluable population

Groups in this outcome

Phase I - JNJ-26866138 0.7 mg/m2 Group

JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

Phase I - JNJ-26866138 1.0 mg/m2 Group

JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

Phase I - JNJ-26866138 1.3 mg/m2 Group

JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles

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 - JNJ-26866138 0.7 mg/m2 Group6
Phase I - JNJ-26866138 1.0 mg/m2 Group6
Phase I - JNJ-26866138 1.3 mg/m2 Group4

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase I - JNJ-26866138 0.7 mg/m2 Group45.4310.087Not reportedNot reportedNot reported
Phase I - JNJ-26866138 1.0 mg/m2 Group59.4218.89Not reportedNot reportedNot reported
Phase I - JNJ-26866138 1.3 mg/m2 Group120.324.527Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        10.087
        value
        45.43
      2. group Id
        OG001
        spread
        18.89
        value
        59.42
      3. group Id
        OG002
        spread
        24.527
        value
        120.3
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Cmax of bortezomib following intravenous administration of JNJ-26866138 at dose of 0.7, 1.0, and 1.3 mg/m2 on Cycle 1/Day 25 (JNJ-26866138 alone)
dispersion Type
Standard Deviation
groups
  1. description
    JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    OG000
    title
    Phase I - JNJ-26866138 0.7 mg/m2 Group
  2. description
    JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    OG001
    title
    Phase I - JNJ-26866138 1.0 mg/m2 Group
  3. description
    JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
    id
    OG002
    title
    Phase I - JNJ-26866138 1.3 mg/m2 Group
param Type
MEAN
population Description
Pharmacokinetics-evaluable population: 16 participants were included in pharmacokinetics-evaluable population
reporting Status
POSTED
time Frame
Day 25 of Cycle 1
title
Maximum Observed Plasma Concentration (Cmax) of Bortezomib (JNJ-26866138 Alone) - Phase I
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice