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NCT02541383 · OUTCOME

Progression Free Survival (PFS) From First Randomization up to the End of the Study

A Study to Evaluate Daratumumab in Transplant Eligible Participants With Previously Untreated Multiple Myeloma · Source last updated 2025-04-13

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 first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study

What was measured

Progression Free Survival (PFS) is defined as the duration from the date of first randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the end of the study

Analysis population: All participants randomized in the first randomization even if they did not receive any study treatment dose.

Groups in this outcome

Arm A - Part 1 up to End of Study

All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) even those who didn't receive any treatment dose.

Arm B - Part 1 up to End of Study

All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) even those who didn't receive any treatment dose.

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 - Part 1 up to End of Study542
Arm B - Part 1 up to End of Study543

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A - Part 1 up to End of Study52.8Not reported47.558.7Not reported
Arm B - Part 1 up to End of Study83.7Not reported70.2NAThe upper limit of the Confidence Interval is not estimable due to insufficient number 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
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.72
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.61
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.52
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.72
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.61
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        47.5
        upper Limit
        58.7
        value
        52.8
      2. comment
        The upper limit of the Confidence Interval is not estimable due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        70.2
        upper Limit
        NA
        value
        83.7
denoms
  1. counts
    1. group Id
      OG000
      value
      542
    2. group Id
      OG001
      value
      543
    units
    Participants
description
Progression Free Survival (PFS) is defined as the duration from the date of first randomization to either progressive disease (according to the IMWG criteria specified in the protocol), or death, whichever occurs first (=all these considered as events) at the end of the study
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients randomized to the VTd group (Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) even those who didn't receive any treatment dose.
    id
    OG000
    title
    Arm A - Part 1 up to End of Study
  2. description
    All patients randomized to the DVTd group (Daratumumab in combination with Bortezomib (VELCADE), Thalidomide, and Dexamethasone) at rando 1 (whether they subsequently had rando 2 or not) even those who didn't receive any treatment dose.
    id
    OG001
    title
    Arm B - Part 1 up to End of Study
param Type
MEDIAN
population Description
All participants randomized in the first randomization even if they did not receive any study treatment dose.
reporting Status
POSTED
time Frame
From the date of first randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 80.1 months at the end of the study
title
Progression Free Survival (PFS) From First Randomization up to the End of the Study
type
SECONDARY
unit Of Measure
Months

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Preserved source evidence · Not medical advice