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NCT02963493 · OUTCOME

Time to Progression

A Study of Melphalan Flufenamide (Melflufen) Plus Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma · Source last updated 2022-11-22

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
From start of treatment to first evidence of disease progression or date of death from any cause, whichever came first. Longest time to progression recorded was 37.2 months at study end.

What was measured

Duration from start of treatment to first evidence of disease progression as assessed by the investigator. See definitions of response and progression in ORR and PFS outcomes.

Analysis population: This outcome measure was prespecified to be analyzed/reported for the Mel + Dex: FAS Arm/Group and Mel + Dex: Patients With TCR Disease. This outcome measure was analyzed/reported for patients in the full analysis set as well as in the sub-group of patients with triple class refractory disease. This outcome measure was not analyzed/reported separately for the sub-group of patients with Extramedullary Disease. No data available to report for EMD patients.

Groups in this outcome

Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set

Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle. Melphalan flufenamide (Melflufen) Dexamethasone

Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease

Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set157
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease119

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set4.4Not reported3.715.32Not reported
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease4.11Not reported3.324.86Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.71
        upper Limit
        5.32
        value
        4.4
      2. group Id
        OG001
        lower Limit
        3.32
        upper Limit
        4.86
        value
        4.11
denoms
  1. counts
    1. group Id
      OG000
      value
      157
    2. group Id
      OG001
      value
      119
    units
    Participants
description
Duration from start of treatment to first evidence of disease progression as assessed by the investigator. See definitions of response and progression in ORR and PFS outcomes.
dispersion Type
95% Confidence Interval
groups
  1. description
    Melphalan flufenamide (melflufen) 40 mg Day 1 and dexamethasone 40 mg (reduced dose for patients 75 years or older) on Days 1, 8, 15 and 22 of each 28-day cycle. Melphalan flufenamide (Melflufen) Dexamethasone
    id
    OG000
    title
    Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set
  2. description
    Triple class refractory population defined as refractory to or intolerant of at least one immunomodulatory drug, at least one proteasome inhibitor, and at least one anti-CD38 monoclonal antibody
    id
    OG001
    title
    Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease
param Type
MEDIAN
population Description
This outcome measure was prespecified to be analyzed/reported for the Mel + Dex: FAS Arm/Group and Mel + Dex: Patients With TCR Disease. This outcome measure was analyzed/reported for patients in the full analysis set as well as in the sub-group of patients with triple class refractory disease. This outcome measure was not analyzed/reported separately for the sub-group of patients with Extramedullary Disease. No data available to report for EMD patients.
reporting Status
POSTED
time Frame
From start of treatment to first evidence of disease progression or date of death from any cause, whichever came first. Longest time to progression recorded was 37.2 months at study end.
title
Time to Progression
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice