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NCT04649060 · OUTCOME

Progression Free Survival (PFS)

Study of Melflufen (Melphalan Flufenamide) in Combination With Daratumumab in Relapsed-Refractory Multiple Myeloma · Source last updated 2023-06-08

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 the date of randomization until the end of study (approximately 12 months).

What was measured

Time from the date of randomization to the date of first documentation of confirmed progressive disease (PD) or death due to any cause, whichever occurred first.

Analysis population: Analysis was performed using the Full Analysis Set (FAS).

Groups in this outcome

Arm A (Melflufen+Dexamethasone+Daratumumab)

Treatment was given in 28-day cycles in an outpatient treatment setting. * Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle * Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years) * Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7

Arm B (Daratumumab)

Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7

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

Analysis denominator · Participants

GroupSource count
Arm A (Melflufen+Dexamethasone+Daratumumab)27
Arm B (Daratumumab)27

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A (Melflufen+Dexamethasone+Daratumumab)NANot reportedNANAThe median PFS was not reached in Arm A. There were insufficient numbers of participants with events.
Arm B (Daratumumab)4.86Not reported3.38NAThe upper confidence limit was not available due to insufficient numbers of participants with events.

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.052
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.650
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0032
    param Type
    Hazard Ratio (HR)
    param Value
    0.184
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.052
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.650
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    =0.0032
    param Type
    Hazard Ratio (HR)
    param Value
    0.184
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The median PFS was not reached in Arm A. There were insufficient numbers of participants with events.
        group Id
        OG000
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      2. comment
        The upper confidence limit was not available due to insufficient numbers of participants with events.
        group Id
        OG001
        lower Limit
        3.38
        upper Limit
        NA
        value
        4.86
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      27
    units
    Participants
description
Time from the date of randomization to the date of first documentation of confirmed progressive disease (PD) or death due to any cause, whichever occurred first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Treatment was given in 28-day cycles in an outpatient treatment setting. * Melflufen 30 mg intravenous (i.v.) infusion on Day 1 of each cycle * Dexamethasone 40 mg per oral (p.o.) weekly (20 mg p.o. weekly if ≥75 years) * Daratumumab 1800 mg subcutaneously (s.c.) on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
    id
    OG000
    title
    Arm A (Melflufen+Dexamethasone+Daratumumab)
  2. description
    Treatment was given in 28-day cycles in an outpatient treatment setting. • Daratumumab 1800 mg s.c. on Days 1, 8, 15, and 22 in Cycles 1 and 2, on Days 1 and 15 in Cycles 3 to 6, and on Day 1 from Cycle 7
    id
    OG001
    title
    Arm B (Daratumumab)
param Type
MEDIAN
population Description
Analysis was performed using the Full Analysis Set (FAS).
reporting Status
POSTED
time Frame
From the date of randomization until the end of study (approximately 12 months).
title
Progression Free Survival (PFS)
type
PRIMARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice