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NCT03639610 · OUTCOME

Cmax of Melphalan

PK of Melphalan During Treatment With Melflufen and Dexamethasone in Patients With RRMM and Impaired Renal Function · Source last updated 2023-03-10

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
Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.

What was measured

Maximum observed concentration (Cmax)

Analysis population: Some patients were not evaluable for pharmacokinetics (PK) and were excluded from Cycle 1 and/or Cycle 2.

Groups in this outcome

Cohort 1a, Melflufen 40 mg

Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.

Cohort 1b, Melflufen 30 mg

Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.

Cohort 2a, Melflufen 20 mg

Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.

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

Analysis denominator · Participants

GroupSource count
Cohort 1a, Melflufen 40 mg21
Cohort 1b, Melflufen 30 mg10
Cohort 2a, Melflufen 20 mg4

Reported measurements

Cycle 1

Analysis denominator · Participants

GroupSource count
Cohort 1a, Melflufen 40 mg13
Cohort 1b, Melflufen 30 mg5
Cohort 2a, Melflufen 20 mg4
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg550.1538170.024Not reportedNot reportedNot reported
Cohort 1b, Melflufen 30 mg472.2000141.505Not reportedNot reportedNot reported
Cohort 2a, Melflufen 20 mg181.250076.098Not reportedNot reportedNot reported
Cycle 2

Analysis denominator · Participants

GroupSource count
Cohort 1a, Melflufen 40 mg9
Cohort 1b, Melflufen 30 mg6
Cohort 2a, Melflufen 20 mg3
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg539.4444178.246Not reportedNot reportedNot reported
Cohort 1b, Melflufen 30 mg469.5000177.340Not reportedNot reportedNot reported
Cohort 2a, Melflufen 20 mg194.000057.663Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        170.024
        value
        550.1538
      2. group Id
        OG001
        spread
        141.505
        value
        472.2000
      3. group Id
        OG002
        spread
        76.098
        value
        181.2500
    denoms
    1. counts
      1. group Id
        OG000
        value
        13
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        4
      units
      Participants
    title
    Cycle 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        178.246
        value
        539.4444
      2. group Id
        OG001
        spread
        177.340
        value
        469.5000
      3. group Id
        OG002
        spread
        57.663
        value
        194.0000
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        3
      units
      Participants
    title
    Cycle 2
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Maximum observed concentration (Cmax)
dispersion Type
Standard Deviation
groups
  1. description
    Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 40 mg.
    id
    OG000
    title
    Cohort 1a, Melflufen 40 mg
  2. description
    Patients with moderate renal impairment (eGFR ≥30 to \<45 mL/min/1.73m²) and a starting dose of melflufen of 30 mg.
    id
    OG001
    title
    Cohort 1b, Melflufen 30 mg
  3. description
    Patients with severe renal impairment (eGFR ≥15 to \<30 mL/min/1.73m²) and a starting dose of melflufen of 20 mg.
    id
    OG002
    title
    Cohort 2a, Melflufen 20 mg
param Type
MEAN
population Description
Some patients were not evaluable for pharmacokinetics (PK) and were excluded from Cycle 1 and/or Cycle 2.
reporting Status
POSTED
time Frame
Samples were drawn 5-10 minutes after the end of infusion, 2-3 hours after the end of infusion, and 5-7 hours after the end of infusion.
title
Cmax of Melphalan
type
PRIMARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice