NCT01592370 · OUTCOME

Objective Response Rate 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: NUMBER
Unit: Percentage
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

Group	Source count
Cohort A-1	6
Cohort A-2	7
Cohort B-1	43
Cohort B-2	22

Reported measurements

Source class 1

Values in Percentage · Interval/dispersion: 95% Confidence Interval
Group	Value	Spread	Lower	Upper	Comment
Cohort A-1	66.7	Not reported	22.3	95.7	Not reported
Cohort A-2	71.4	Not reported	29.0	93.3	Not reported
Cohort B-1	51.2	Not reported	35.5	66.7	Not reported
Cohort B-2	36.4	Not reported	17.2	59.3	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
lower Limit
22.3
upper Limit
95.7
value
66.7
group Id
OG001
lower Limit
29.0
upper Limit
93.3
value
71.4
group Id
OG002
lower Limit
35.5
upper Limit
66.7
value
51.2
group Id
OG003
lower Limit
17.2
upper Limit
59.3
value
36.4

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
7
group Id
OG002
value
43
group Id
OG003
value
22
units
Participants

dispersion Type

95% Confidence Interval

groups

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
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
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
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

NUMBER

population Description

All randomized participants in the nivo dara cohort

reporting Status

POSTED

time Frame

approximately up to 4 years

title

Objective Response Rate in the Nivolumab + Daratumumab Cohort

type

SECONDARY

unit Of Measure

Percentage

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

Preserved source evidence · Not medical advice