Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02541383 · OUTCOME

Progression Free Survival (PFS) Post Completion of Maintenance Therapy

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 second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date).

What was measured

Progression Free Survival (PFS) post completion of maintenance therapy is defined as the duration from the date of second 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 completion of Maintenance therapy.

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

Groups in this outcome

Arm A Part 2

All patients randomized to the Observation group at rando 2 (whatever the treatment allocated at rando 1)

Arm B Part 2

All patients randomized to the Daratumumab group at rando 2 even those who didn't receive any treatment dose (whatever the treatment allocated at rando 1). Daratumumab: Daratumumab 16mg/kg every 8 weeks for 2 years

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 2444
Arm B Part 2442

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Arm A Part 246.7Not reported40.0NAThe upper limit of the Confidence Interval is not estimable due to insufficient number of participants with events.
Arm B Part 2NANot reportedNANAThe Median time to progression was not reached in this arm. Consequently, the lower and upper limit of the Confidence Interval is not available 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
    0.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.68
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
Complete source fields
analyses
  1. ci Lower Limit
    0.42
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    0.68
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY
    p Value
    <0.0001
    param Type
    Hazard Ratio (HR)
    param Value
    0.53
    statistical Method
    Log Rank
classes
  1. categories
    1. measurements
      1. comment
        The upper limit of the Confidence Interval is not estimable due to insufficient number of participants with events.
        group Id
        OG000
        lower Limit
        40.0
        upper Limit
        NA
        value
        46.7
      2. comment
        The Median time to progression was not reached in this arm. Consequently, the lower and upper limit of the Confidence Interval is not available due to insufficient number of participants with events.
        group Id
        OG001
        lower Limit
        NA
        upper Limit
        NA
        value
        NA
denoms
  1. counts
    1. group Id
      OG000
      value
      444
    2. group Id
      OG001
      value
      442
    units
    Participants
description
Progression Free Survival (PFS) post completion of maintenance therapy is defined as the duration from the date of second 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 completion of Maintenance therapy.
dispersion Type
95% Confidence Interval
groups
  1. description
    All patients randomized to the Observation group at rando 2 (whatever the treatment allocated at rando 1)
    id
    OG000
    title
    Arm A Part 2
  2. description
    All patients randomized to the Daratumumab group at rando 2 even those who didn't receive any treatment dose (whatever the treatment allocated at rando 1). Daratumumab: Daratumumab 16mg/kg every 8 weeks for 2 years
    id
    OG001
    title
    Arm B Part 2
param Type
MEDIAN
population Description
All participants randomized in the second randomization even if they did not receive any study treatment dose.
reporting Status
POSTED
time Frame
From the date of second randomization to either progressive disease or death which ever occurred first, with a median follow-up time of 35.4 months (cut-off for analysis was 26 months after the last rando 2 date).
title
Progression Free Survival (PFS) Post Completion of Maintenance Therapy
type
PRIMARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice