Skip to content
Triangle logo TriangleGet started
← Full study record

NCT03639610 · OUTCOME

Overall Survival

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
95% Confidence Interval
Time frame
Patients were followed for overall survival until death or until the last patient in the study had documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (maximum of 39.2 months).

What was measured

Overall survival was defined as the time in months from initiation of therapy to death due to any cause. Patients still alive at the end of the study, or lost to follow up, were censored at last day known alive.

Analysis population: This analysis was performed in the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.

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

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg9.76Not reported5.0615.38Not reported
Cohort 1b, Melflufen 30 mgNANot reported6.83NAData not estimable. Death due to any cause occurred in 3 patients (as reported at both data cuts). The median and upper limit were not reached due to too few events
Cohort 2a, Melflufen 20 mgNANot reported3.15NAData not estimable. Death due to any cause occurred in 1 patient; the patient had a survival time of 3.15 months.The median and upper limit were not reached due to too few events
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.06
        upper Limit
        15.38
        value
        9.76
      2. comment
        Data not estimable. Death due to any cause occurred in 3 patients (as reported at both data cuts). The median and upper limit were not reached due to too few events
        group Id
        OG001
        lower Limit
        6.83
        upper Limit
        NA
        value
        NA
      3. comment
        Data not estimable. Death due to any cause occurred in 1 patient; the patient had a survival time of 3.15 months.The median and upper limit were not reached due to too few events
        group Id
        OG002
        lower Limit
        3.15
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Overall survival was defined as the time in months from initiation of therapy to death due to any cause. Patients still alive at the end of the study, or lost to follow up, were censored at last day known alive.
dispersion Type
95% Confidence Interval
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 was performed in the Safety Analysis Set, which is defined as all patients who received at least 1 or partial dose of melflufen or dexamethasone.
reporting Status
POSTED
time Frame
Patients were followed for overall survival until death or until the last patient in the study had documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (maximum of 39.2 months).
title
Overall Survival
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice