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NCT01592370 · OUTCOME

AUC (0-T) 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
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
approximately up to 4 years

What was measured

Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration

Analysis population: All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0

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-10
Cohort A-20
Cohort B-10
Cohort B-20

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    3. group Id
      OG002
      value
      0
    4. group Id
      OG003
      value
      0
    units
    Participants
description
Area under the plasma concentration-time curve from time zero to the last time of the last quantifiable concentration
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
population Description
All treated participants - Please note that blood sampling collection for PK endpoints was limited to end-of-infusion samples and pre-dose samples only. Because there was no blood sampling throughout a dosing interval, values for this PK endpoint can't be determined as we do not have the raw nivolumab concentration-time data necessary to do so. Hence, number of participants analyzed is set at 0
reporting Status
POSTED
time Frame
approximately up to 4 years
title
AUC (0-T) in the Nivolumab + Daratumumab Cohort
type
SECONDARY

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

Preserved source evidence · Not medical advice