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NCT03639610 · OUTCOME

Time to Response

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
months
Interval / dispersion
Full Range
Time frame
From initiation of therapy until documented disease response (maximum duration 127.1 weeks).

What was measured

Time from first dose of therapy to first documented confirmed response of partial response (PR) or better.

Analysis population: This analysis included patients who achieved a best confirmed response of PR or better.

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 mg10
Cohort 1b, Melflufen 30 mg7
Cohort 2a, Melflufen 20 mg1

Reported measurements

Source class 1
Values in months · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg2.45Not reported1.011.3Not reported
Cohort 1b, Melflufen 30 mg1.18Not reported0.97.6Not reported
Cohort 2a, Melflufen 20 mg2.83Not reported2.832.83Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.0
        upper Limit
        11.3
        value
        2.45
      2. group Id
        OG001
        lower Limit
        0.9
        upper Limit
        7.6
        value
        1.18
      3. group Id
        OG002
        lower Limit
        2.83
        upper Limit
        2.83
        value
        2.83
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Time from first dose of therapy to first documented confirmed response of partial response (PR) or better.
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
This analysis included patients who achieved a best confirmed response of PR or better.
reporting Status
POSTED
time Frame
From initiation of therapy until documented disease response (maximum duration 127.1 weeks).
title
Time to Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice