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NCT03639610 · OUTCOME

Best Confirmed 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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Patients were assessed for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).

What was measured

Best confirmed response required 2 consecutive assessments with the same response result made at any time. In case at the second consecutive assessment (made at any time) the response is higher than the previous one, then confirmed response (linked to the first assessment visit) will be the first one (e.g., PR - VGPR consecutive pair will lead to a PR confirmed response at the first visit). In case the second consecutive response is lower than the first one, then confirmed response (linked to the first assessment visit) will be the second one (e.g. CR-VGPR consecutive pair will lead to a VGPR confirmed response at the first visit).

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

Stringent complete response (sCR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg0Not reportedNot reportedNot reportedNot reported
Cohort 1b, Melflufen 30 mg0Not reportedNot reportedNot reportedNot reported
Cohort 2a, Melflufen 20 mg0Not reportedNot reportedNot reportedNot reported
Complete response (CR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg0Not reportedNot reportedNot reportedNot reported
Cohort 1b, Melflufen 30 mg2Not reportedNot reportedNot reportedNot reported
Cohort 2a, Melflufen 20 mg0Not reportedNot reportedNot reportedNot reported
Very good partial response (VGPR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg3Not reportedNot reportedNot reportedNot reported
Cohort 1b, Melflufen 30 mg1Not reportedNot reportedNot reportedNot reported
Cohort 2a, Melflufen 20 mg0Not reportedNot reportedNot reportedNot reported
Partial response (PR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg7Not reportedNot reportedNot reportedNot reported
Cohort 1b, Melflufen 30 mg4Not reportedNot reportedNot reportedNot reported
Cohort 2a, Melflufen 20 mg1Not reportedNot reportedNot reportedNot reported
Minimal response (MR)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg1Not reportedNot reportedNot reportedNot reported
Cohort 1b, Melflufen 30 mg1Not reportedNot reportedNot reportedNot reported
Cohort 2a, Melflufen 20 mg0Not reportedNot reportedNot reportedNot reported
Stable disease (SD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg5Not reportedNot reportedNot reportedNot reported
Cohort 1b, Melflufen 30 mg2Not reportedNot reportedNot reportedNot reported
Cohort 2a, Melflufen 20 mg0Not reportedNot reportedNot reportedNot reported
Progressive disease (PD)
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg2Not reportedNot reportedNot reportedNot reported
Cohort 1b, Melflufen 30 mg0Not reportedNot reportedNot reportedNot reported
Cohort 2a, Melflufen 20 mg3Not reportedNot reportedNot reportedNot reported
Non-evaluable
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Cohort 1a, Melflufen 40 mg3Not reportedNot reportedNot reportedNot reported
Cohort 1b, Melflufen 30 mg0Not reportedNot reportedNot reportedNot reported
Cohort 2a, Melflufen 20 mg0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Stringent complete response (sCR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Complete response (CR)
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Very good partial response (VGPR)
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        1
    title
    Partial response (PR)
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        0
    title
    Minimal response (MR)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        0
    title
    Stable disease (SD)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        3
    title
    Progressive disease (PD)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
    title
    Non-evaluable
denoms
  1. counts
    1. group Id
      OG000
      value
      21
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      4
    units
    Participants
description
Best confirmed response required 2 consecutive assessments with the same response result made at any time. In case at the second consecutive assessment (made at any time) the response is higher than the previous one, then confirmed response (linked to the first assessment visit) will be the first one (e.g., PR - VGPR consecutive pair will lead to a PR confirmed response at the first visit). In case the second consecutive response is lower than the first one, then confirmed response (linked to the first assessment visit) will be the second one (e.g. CR-VGPR consecutive pair will lead to a VGPR confirmed response at the first visit).
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
COUNT_OF_PARTICIPANTS
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 for response after each cycle. After discontinuation of therapy, patients continued to be assessed until documented progression (confirmed on 2 consecutive assessments) or initiation of subsequent therapy (max duration 127.1 weeks).
title
Best Confirmed Response
type
SECONDARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice