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NCT00765102 · OUTCOME

Maximum Observed Concentration (Cmax)

Trial of Romidepsin and Bortezomib for Multiple Myeloma · Source last updated 2019-11-25

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

Measure
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion

What was measured

Maximum observed concentration of Romidepsin

Analysis population: A subset of participants from the lead investigator's site had PK samples taken.

Groups in this outcome

Romidepsin 8 mg/m^2 + Bortezomib

Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m\^2.

Romidepsin 10 mg/m^2 + Bortezomib

Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.

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

Analysis denominator · Participants

GroupSource count
Romidepsin 8 mg/m^2 + Bortezomib6
Romidepsin 10 mg/m^2 + Bortezomib5

Reported measurements

Source class 1
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Romidepsin 8 mg/m^2 + Bortezomib913.921.4Not reportedNot reportedNot reported
Romidepsin 10 mg/m^2 + Bortezomib1002.720.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        21.4
        value
        913.9
      2. group Id
        OG001
        spread
        20.6
        value
        1002.7
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      5
    units
    Participants
description
Maximum observed concentration of Romidepsin
dispersion Type
Geometric Coefficient of Variation
groups
  1. description
    Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 8mg/m\^2.
    id
    OG000
    title
    Romidepsin 8 mg/m^2 + Bortezomib
  2. description
    Each patient enrolled in the PK portion underwent one PK sampling period on Day 1 of Cycle 1, following the administration of Bortezomib and 1-hour IV infusion of romidepsin 10mg/m\^2.
    id
    OG001
    title
    Romidepsin 10 mg/m^2 + Bortezomib
param Type
GEOMETRIC_MEAN
population Description
A subset of participants from the lead investigator's site had PK samples taken.
reporting Status
POSTED
time Frame
Day 1 (cycle 1): 1 hour prior to romidepsin administration, 0.25, 0.5, 1, 2, 3, 4, 6, and 24 hours after initiation of romidepsin infusion
title
Maximum Observed Concentration (Cmax)
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice