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NCT04649060 · OUTCOME

Time to Response (TTR)

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
MEAN
Unit
months
Interval / dispersion
Standard Deviation
Time frame
From the date of randomization until the end of study (approximately 12 months).

What was measured

Time from randomization to the date of the first documented confirmed response in a patient who has responded with ≥PR.

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: Standard Deviation
GroupValueSpreadLowerUpperComment
Arm A (Melflufen+Dexamethasone+Daratumumab)1.81.0Not reportedNot reportedNot reported
Arm B (Daratumumab)1.81.1Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.0
        value
        1.8
      2. group Id
        OG001
        spread
        1.1
        value
        1.8
denoms
  1. counts
    1. group Id
      OG000
      value
      27
    2. group Id
      OG001
      value
      27
    units
    Participants
description
Time from randomization to the date of the first documented confirmed response in a patient who has responded with ≥PR.
dispersion Type
Standard Deviation
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
MEAN
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
Time to Response (TTR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice