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NCT03639610 · OUTCOME

Progression-free 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 assessed from the initiation of therapy until documented disease progression or initiation of new therapy (maximum duration 127.1 weeks).

What was measured

Progression-free survival (PFS) was defined as the time from the date of first study drug (the earliest of melflufen and dexamethasone start date) initiation to the date of first documentation of confirmed PD or death due to any cause, whichever occurred first. Participants were deemed 'progressed' in case of i) unconfirmed progressive disease (PD) as the final response assessment, ii) death after at least one response assessment or PD based on at least two consecutive response assessments at any time, or iii) death before the first response assessment. The distribution of PFS was summarized using the Kaplan-Meier (K-M) method. The median PFS was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median PFS was constructed using the method of Brookmeyer (Brookmeyer, 1982).

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 mg8.61Not reported4.3014.52Not reported
Cohort 1b, Melflufen 30 mg7.66Not reported6.24NAData not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events
Cohort 2a, Melflufen 20 mg3.43Not reported0.95NAData not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.30
        upper Limit
        14.52
        value
        8.61
      2. comment
        Data not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events
        group Id
        OG001
        lower Limit
        6.24
        upper Limit
        NA
        value
        7.66
      3. comment
        Data not estimable. At the final data cut the upper limit CI was not reached at the previous data cut due to too few events
        group Id
        OG002
        lower Limit
        0.95
        upper Limit
        NA
        value
        3.43
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Progression-free survival (PFS) was defined as the time from the date of first study drug (the earliest of melflufen and dexamethasone start date) initiation to the date of first documentation of confirmed PD or death due to any cause, whichever occurred first. Participants were deemed 'progressed' in case of i) unconfirmed progressive disease (PD) as the final response assessment, ii) death after at least one response assessment or PD based on at least two consecutive response assessments at any time, or iii) death before the first response assessment. The distribution of PFS was summarized using the Kaplan-Meier (K-M) method. The median PFS was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median PFS was constructed using the method of Brookmeyer (Brookmeyer, 1982).
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 assessed from the initiation of therapy until documented disease progression or initiation of new therapy (maximum duration 127.1 weeks).
title
Progression-free Survival
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice