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NCT01592370 · OUTCOME

Duration of Response in the Nivolumab + Daratumumab Cohort

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
approximately up to 4 years

Analysis population: All randomized participants in the nivo dara cohort

Groups in this outcome

Cohort A-1

ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects \> 75 years old

Cohort A-2

ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1

Cohort B-1

ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1\*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1

Cohort B-2

D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1\*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1

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

Analysis denominator · Participants

GroupSource count
Cohort A-16
Cohort A-27
Cohort B-143
Cohort B-222

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Cohort A-1NANot reported6.47NAinusufficient number of participants with a response to calculable by KM methodology
Cohort A-2NANot reported9.30NAinusufficient number of participants with a response to calculable by KM methodology
Cohort B-16.70Not reported3.7114.29Not reported
Cohort B-212.98Not reported2.20NAinusufficient number of participants with a response to calculable by KM methodology
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        inusufficient number of participants with a response to calculable by KM methodology
        group Id
        OG000
        lower Limit
        6.47
        upper Limit
        NA
        value
        NA
      2. comment
        inusufficient number of participants with a response to calculable by KM methodology
        group Id
        OG001
        lower Limit
        9.30
        upper Limit
        NA
        value
        NA
      3. group Id
        OG002
        lower Limit
        3.71
        upper Limit
        14.29
        value
        6.70
      4. comment
        inusufficient number of participants with a response to calculable by KM methodology
        group Id
        OG003
        lower Limit
        2.20
        upper Limit
        NA
        value
        12.98
denoms
  1. counts
    1. group Id
      OG000
      value
      6
    2. group Id
      OG001
      value
      7
    3. group Id
      OG002
      value
      43
    4. group Id
      OG003
      value
      22
    units
    Participants
dispersion Type
95% Confidence Interval
groups
  1. description
    ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1 Pomalidomide: 4 mg po daily (Days 1-21) of each 28-day cycle Dexamethasone: Weeks without daratumumab dosing 40 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects 75 years old 20 mg po per day (Days 1, 8, 15, 22) of each 28-day cycle for subjects \> 75 years old
    id
    OG000
    title
    Cohort A-1
  2. description
    ND-Pd Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2-6: 240 mg iv Days 1, 15 Cycle 7 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1
    id
    OG001
    title
    Cohort A-2
  3. description
    ND Regimen Each cycle is 28 days Nivolumab: Cycle 1: 240 mg iv Day 15 Cycle 2 \& beyond: 480 mg iv Day 1 Daratumumab: Cycle 1\*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1
    id
    OG002
    title
    Cohort B-1
  4. description
    D Monotherapy Regimen Each cycle is 28 days Daratumumab: Cycle 1\*-2: 16 mg/kg iv Days 1, 8, 15, 22 Cycle 3-6: 16 mg/kg iv Days 1, 15 Cycle 7 \& beyond: 16 mg/kg iv Day 1
    id
    OG003
    title
    Cohort B-2
param Type
MEDIAN
population Description
All randomized participants in the nivo dara cohort
reporting Status
POSTED
time Frame
approximately up to 4 years
title
Duration of Response in the Nivolumab + Daratumumab Cohort
type
SECONDARY
unit Of Measure
Months

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

Preserved source evidence · Not medical advice