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NCT03481556 · OUTCOME

Duration of Response (DOR)

Study of Melphalan Flufenamide (Melflufen) + Dex With Bortezomib or Daratumumab in Patients With RRMM · Source last updated 2022-12-19

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
Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)

What was measured

DOR is defined for participants with confirmed objective response (PR or better, which includes PR, VGPR, CR and sCR) as the time from the first documentation of objective response to the first documentation of objective progression or to death due to any cause, whichever occurs first.

Analysis population: Only participants included in the Safety Analysis Set who achieved a response of PR or better were included in this analysis.

Groups in this outcome

A (Melflufen+Bortezomib+Dex) 30 mg

Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.

A (Melflufen+Bortezomib+Dex) 40 mg

Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.

B (Melflufen+Daratumumab+Dex) 30 mg

Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).

B (Melflufen+Daratumumab+Dex) 40 mg

Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).

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

Analysis denominator · Participants

GroupSource count
A (Melflufen+Bortezomib+Dex) 30 mg12
A (Melflufen+Bortezomib+Dex) 40 mg6
B (Melflufen+Daratumumab+Dex) 30 mg5
B (Melflufen+Daratumumab+Dex) 40 mg19

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
A (Melflufen+Bortezomib+Dex) 30 mg9.0Not reported4.9NAUpper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
A (Melflufen+Bortezomib+Dex) 40 mgNANot reportedNANAMedian and confidence interval values could not be calculated as the fraction of participants experiencing events was too low.
B (Melflufen+Daratumumab+Dex) 30 mg24.2Not reported10.60NAUpper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
B (Melflufen+Daratumumab+Dex) 40 mg9.9Not reported7.214.8Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
        group Id
        OG000
        lower Limit
        4.9
        upper Limit
        NA
        value
        9.0
      2. comment
        Median and confidence interval values could not be calculated as the fraction of participants experiencing events was too low.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
      3. comment
        Upper confidence interval value could not be calculated as the fraction of participants experiencing events was too low.
        group Id
        OG002
        lower Limit
        10.60
        upper Limit
        NA
        value
        24.2
      4. group Id
        OG003
        lower Limit
        7.2
        upper Limit
        14.8
        value
        9.9
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      5
    4. group Id
      OG003
      value
      19
    units
    Participants
description
DOR is defined for participants with confirmed objective response (PR or better, which includes PR, VGPR, CR and sCR) as the time from the first documentation of objective response to the first documentation of objective progression or to death due to any cause, whichever occurs first.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
    id
    OG000
    title
    A (Melflufen+Bortezomib+Dex) 30 mg
  2. description
    Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with SQ bortezomib at a dose of 1.3mg/m\^2 on Days 1, 4, 8, and 11 and dexamethasone PO at a dose of 20 mg (12 mg if the participants is ≥ 75 years of age) on Days 1, 4, 8, and 11 and 40 mg (20 mg if the participants is ≥ 75 years of age) on Day 15 and 22 of each 28-day cycle.
    id
    OG001
    title
    A (Melflufen+Bortezomib+Dex) 40 mg
  3. description
    Participants were administered IV melflufen at a dose of 30 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
    id
    OG002
    title
    B (Melflufen+Daratumumab+Dex) 30 mg
  4. description
    Participants were administered IV melflufen at a dose of 40 mg on Day 1 of each 28-day cycle in combination with IV daratumumab at a dose of 16 mg/kg weekly for 8 doses, every other week for 8 doses and then once every 4 weeks. Participants were also administered dexamethasone orally (PO) at a dose of 40 mg weekly (20 mg weekly if the participants is ≥ 75 years of age).
    id
    OG003
    title
    B (Melflufen+Daratumumab+Dex) 40 mg
param Type
MEDIAN
population Description
Only participants included in the Safety Analysis Set who achieved a response of PR or better were included in this analysis.
reporting Status
POSTED
time Frame
Until disease progression, death or initiation of subsequent therapy (a maximum of 194.3 weeks)
title
Duration of Response (DOR)
type
SECONDARY
unit Of Measure
months

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

Preserved source evidence · Not medical advice