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NCT03639610 · OUTCOME

Tmax 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
MEDIAN
Unit
minutes
Interval / dispersion
Full Range
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

Time of maximum observed concentration (Tmax)

Analysis population: Some patients were not evaluable for 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 minutes · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg38.0000Not reported35.000040.0000Not reported
Cohort 1b, Melflufen 30 mg40.0000Not reported35.000045.0000Not reported
Cohort 2a, Melflufen 20 mg37.0000Not reported36.000040.0000Not 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 minutes · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg37.0000Not reported35.000040.0000Not reported
Cohort 1b, Melflufen 30 mg40.0000Not reported38.000040.0000Not reported
Cohort 2a, Melflufen 20 mg36.0000Not reported35.000037.0000Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        35.0000
        upper Limit
        40.0000
        value
        38.0000
      2. group Id
        OG001
        lower Limit
        35.0000
        upper Limit
        45.0000
        value
        40.0000
      3. group Id
        OG002
        lower Limit
        36.0000
        upper Limit
        40.0000
        value
        37.0000
    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
        lower Limit
        35.0000
        upper Limit
        40.0000
        value
        37.0000
      2. group Id
        OG001
        lower Limit
        38.0000
        upper Limit
        40.0000
        value
        40.0000
      3. group Id
        OG002
        lower Limit
        35.0000
        upper Limit
        37.0000
        value
        36.0000
    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
Time of maximum observed concentration (Tmax)
dispersion Type
Full Range
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
MEDIAN
population Description
Some patients were not evaluable for 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
Tmax of Melphalan
type
PRIMARY
unit Of Measure
minutes

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Preserved source evidence · Not medical advice