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NCT01712789 · OUTCOME

Pomalidomide Exposure - Apparent Volume of Distribution (V/F)

Evaluation of Safety of Pomalidomide in Combination With Dexamethasone (Low Dose) in Patients With Refractory or Relapsed and Refractory Multiple Myeloma · Source last updated 2022-01-10

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

Measure
MEDIAN
Unit
Liters
Interval / dispersion
95% Confidence Interval
Time frame
Cycles 1, 2, 3, 4, 5, 6

What was measured

Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.

Analysis population: Pharmacokinetic population Pharmacokinetic samples from 476 participants included in studies CC-4047-MM-005 and CC 4047 MM 010 were used for the population PK analysis of pomalidomide

Groups in this outcome

Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)

Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.

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

Analysis denominator · Participants

GroupSource count
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)476

Reported measurements

Source class 1
Values in Liters · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)75.10Not reported63.5789.17Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        63.57
        upper Limit
        89.17
        value
        75.10
denoms
  1. counts
    1. group Id
      OG000
      value
      476
    units
    Participants
description
Pharmacokinetic (PK) parameters are derived from Pomalidomide concentration versus time data.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants received 4 mg pomalidomide (POM) by mouth (PO) on Days 1 to 21 of each 28-day treatment cycle and low dose dexamethasone (LD-Dex) PO at the starting dose of 40 mg/day (≤ 75 years old) or 20 mg/day (\> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle until the documentation of confirmed progressive disease (PD), intolerable toxicity, death, withdrawal of participation in the study/consent, lost to follow-up, or as long as they benefited from therapy according to the opinion of the responsible study investigator.
    id
    OG000
    title
    Pomalidomide Plus Low Dose Dexamethasone (LD-Dex)
param Type
MEDIAN
population Description
Pharmacokinetic population Pharmacokinetic samples from 476 participants included in studies CC-4047-MM-005 and CC 4047 MM 010 were used for the population PK analysis of pomalidomide
reporting Status
POSTED
time Frame
Cycles 1, 2, 3, 4, 5, 6
title
Pomalidomide Exposure - Apparent Volume of Distribution (V/F)
type
SECONDARY
unit Of Measure
Liters

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

Preserved source evidence · Not medical advice