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NCT02963493 · OUTCOME

Duration of Response

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 date of response until the date of first documented progression or date of death from any cause, whichever came first. Longest time of response recorded as 36.2 months at study end.

What was measured

Time from first response to progression based on investigator assessment. See definitions of response and progression in ORR and PFS outcomes.

Analysis population: Patients with a best response of PR or better as determined by the investigator.

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: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.

Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease

Patients with extramedullary disease at baseline defined as myeloma disease either originating in, but extending beyond, the cortical bone or as a separate soft tissue mass

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 Set47
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease15
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease31

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set6.90Not reported4.4010.38Not reported
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease5.49Not reported2.1012.71Not reported
Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease7.46Not reported4.2410.38Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        4.40
        upper Limit
        10.38
        value
        6.90
      2. group Id
        OG001
        lower Limit
        2.10
        upper Limit
        12.71
        value
        5.49
      3. group Id
        OG002
        lower Limit
        4.24
        upper Limit
        10.38
        value
        7.46
denoms
  1. counts
    1. group Id
      OG000
      value
      47
    2. group Id
      OG001
      value
      15
    3. group Id
      OG002
      value
      31
    units
    Participants
description
Time from first response to progression based on investigator assessment. 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: IV dexamethasone may be substituted for oral dexamethasone in the US. Oral only in Europe.
    id
    OG000
    title
    Melphalan Flufenamide (Melflufen) + Dexamethasone: Full Analysis Set
  2. description
    Patients with extramedullary disease at baseline defined as myeloma disease either originating in, but extending beyond, the cortical bone or as a separate soft tissue mass
    id
    OG001
    title
    Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Extramedullary Disease
  3. 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
    OG002
    title
    Melphalan Flufenamide (Melflufen) + Dexamethasone: Patients With Triple Class Refractory Disease
param Type
MEDIAN
population Description
Patients with a best response of PR or better as determined by the investigator.
reporting Status
POSTED
time Frame
From date of response until the date of first documented progression or date of death from any cause, whichever came first. Longest time of response recorded as 36.2 months at study end.
title
Duration of Response
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice