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NCT01592370 · OUTCOME

Progression Free Survival

An Investigational Immuno-Therapy Study to Determine the Safety and Effectiveness of Nivolumab and Daratumumab in Patients With Multiple Myeloma · Source last updated 2025-10-22

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 date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)

What was measured

Progression free survival (PFS) is defined as the time between date of randomization and date of progression or death, whichever occurs first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not progress or die were censored on the date of their last efficacy assessment.

Analysis population: All Treated Participants with available measurements

Groups in this outcome

Nivolumab Monotherapy (Expansion)

3mg/kg of nivolumab

Nivolumab + Ipilimumab

3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W

Nivolumab + Lirilumab

3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W

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

Analysis denominator · Participants

GroupSource count
Nivolumab Monotherapy (Expansion)104
Nivolumab + Ipilimumab65
Nivolumab + Lirilumab72

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Nivolumab Monotherapy (Expansion)6.24Not reported3.489.79Not reported
Nivolumab + Ipilimumab6.93Not reported2.7919.15Not reported
Nivolumab + Lirilumab3.02Not reported1.845.52Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.48
        upper Limit
        9.79
        value
        6.24
      2. group Id
        OG001
        lower Limit
        2.79
        upper Limit
        19.15
        value
        6.93
      3. group Id
        OG002
        lower Limit
        1.84
        upper Limit
        5.52
        value
        3.02
denoms
  1. counts
    1. group Id
      OG000
      value
      104
    2. group Id
      OG001
      value
      65
    3. group Id
      OG002
      value
      72
    units
    Participants
description
Progression free survival (PFS) is defined as the time between date of randomization and date of progression or death, whichever occurs first. Participants who died without a reported prior progression were considered to have progressed on the date of their death. Subjects who did not progress or die were censored on the date of their last efficacy assessment.
dispersion Type
95% Confidence Interval
groups
  1. description
    3mg/kg of nivolumab
    id
    OG000
    title
    Nivolumab Monotherapy (Expansion)
  2. description
    3 mg/kg of nivolumab and 1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
    id
    OG001
    title
    Nivolumab + Ipilimumab
  3. description
    3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
    id
    OG002
    title
    Nivolumab + Lirilumab
param Type
MEDIAN
population Description
All Treated Participants with available measurements
reporting Status
POSTED
time Frame
From date of randomization to date of progression or death, whichever occurs first (up to approximately 24 months)
title
Progression Free Survival
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice