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NCT01553149 · OUTCOME

Pharmacokinetic Parameters of Lenalidomide

Low-Dose or High-Dose Lenalidomide in Treating Younger Patients With Recurrent, Refractory, or Progressive Pilocytic Astrocytoma or Optic Pathway Glioma · Source last updated 2025-01-07

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

Measure
MEDIAN
Unit
nanograms per mL
Interval / dispersion
Inter-Quartile Range
Time frame
Between days 5-21 of course 1 and each dose reduction

What was measured

Concentration of lenalidomide obtained from any day between day 5 and 21 of the first cycle of chemotherapy in nanograms per mL.

Analysis population: Only eligible patients who have lenalidomide concentration measure are considered in the analysis of this secondary outcome measure

Groups in this outcome

Arm I (Low-dose Lenalidomide)

Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies

Arm II (High-dose Lenalidomide)

Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies

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

Analysis denominator · Participants

GroupSource count
Arm I (Low-dose Lenalidomide)22
Arm II (High-dose Lenalidomide)25

Reported measurements

Source class 1
Values in nanograms per mL · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
Arm I (Low-dose Lenalidomide)15.1Not reported7.036.8Not reported
Arm II (High-dose Lenalidomide)178.8Not reported68.5391.7Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        7.0
        upper Limit
        36.8
        value
        15.1
      2. group Id
        OG001
        lower Limit
        68.5
        upper Limit
        391.7
        value
        178.8
denoms
  1. counts
    1. group Id
      OG000
      value
      22
    2. group Id
      OG001
      value
      25
    units
    Participants
description
Concentration of lenalidomide obtained from any day between day 5 and 21 of the first cycle of chemotherapy in nanograms per mL.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Patients receive low-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
    id
    OG000
    title
    Arm I (Low-dose Lenalidomide)
  2. description
    Patients receive high-dose lenalidomide PO QD on days 1-21. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Lenalidomide: Given PO Pharmacological Study: Correlative studies
    id
    OG001
    title
    Arm II (High-dose Lenalidomide)
param Type
MEDIAN
population Description
Only eligible patients who have lenalidomide concentration measure are considered in the analysis of this secondary outcome measure
reporting Status
POSTED
time Frame
Between days 5-21 of course 1 and each dose reduction
title
Pharmacokinetic Parameters of Lenalidomide
type
SECONDARY
unit Of Measure
nanograms per mL

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

Preserved source evidence · Not medical advice