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NCT03639610 · OUTCOME

Duration of 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
95% Confidence Interval
Time frame
Patients were assessed for response from the first measure of a confirmed response (PR or better) until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).

What was measured

Duration of response (DOR) is defined as the time from the first evidence of confirmed assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) to first confirmed disease progression, or to death due to any cause. The distribution of DOR was summarized using the Kaplan-Meier (K-M) method. The median DOR was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median DOR was constructed using the method of Brookmeyer (Brookmeyer, 1982).

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: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg8.31Not reported5.8223.49Not reported
Cohort 1b, Melflufen 30 mg13.83Not reported4.63NAData 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 mgNANot reportedNANAData not estimable due to an insufficient number of patients. Only one patient had a best response of confirmed PR or better
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        5.82
        upper Limit
        23.49
        value
        8.31
      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
        4.63
        upper Limit
        NA
        value
        13.83
      3. comment
        Data not estimable due to an insufficient number of patients. Only one patient had a best response of confirmed PR or better
        group Id
        OG002
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      1
    units
    Participants
description
Duration of response (DOR) is defined as the time from the first evidence of confirmed assessment of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) to first confirmed disease progression, or to death due to any cause. The distribution of DOR was summarized using the Kaplan-Meier (K-M) method. The median DOR was estimated from the 50th percentile of the corresponding K-M estimates. The 95% confidence interval for median DOR 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 included patients who achieved a best confirmed response of PR or better.
reporting Status
POSTED
time Frame
Patients were assessed for response from the first measure of a confirmed response (PR or better) until confirmed progression, death, or initiation of subsequent therapy (maximum duration 127.1 weeks).
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice