NCT01592370 · OUTCOME

Number of Participants That Experienced Drug-related Grade 3-4 SAEs 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: COUNT_OF_PARTICIPANTS
Unit: Participants
Interval / dispersion: Not reported
Time frame: approximately up to 4 years

Analysis population: All treated participants in the nivo dara cohort

Groups in this outcome

Nivolumab + Daratumumab_Cohort A1

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

Nivolumab + Daratumumab_Cohort A2

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

Nivolumab + Daratumumab_Cohort B1

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

Nivolumab + Daratumumab_Cohort B2

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
Nivolumab + Daratumumab_Cohort A1	6
Nivolumab + Daratumumab_Cohort A2	5
Nivolumab + Daratumumab_Cohort B1	41
Nivolumab + Daratumumab_Cohort B2	22

Reported measurements

Source class 1

Values in Participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Nivolumab + Daratumumab_Cohort A1	2	Not reported	Not reported	Not reported	Not reported
Nivolumab + Daratumumab_Cohort A2	4	Not reported	Not reported	Not reported	Not reported
Nivolumab + Daratumumab_Cohort B1	10	Not reported	Not reported	Not reported	Not reported
Nivolumab + Daratumumab_Cohort B2	6	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
group Id
OG002
value
10
group Id
OG003
value
6

denoms

counts
group Id
OG000
value
6
group Id
OG001
value
5
group Id
OG002
value
41
group Id
OG003
value
22
units
Participants

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
Nivolumab + Daratumumab_Cohort A1
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
Nivolumab + Daratumumab_Cohort A2
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
Nivolumab + Daratumumab_Cohort B1
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
Nivolumab + Daratumumab_Cohort B2

param Type

COUNT_OF_PARTICIPANTS

population Description

All treated participants in the nivo dara cohort

reporting Status

POSTED

time Frame

approximately up to 4 years

title

Number of Participants That Experienced Drug-related Grade 3-4 SAEs in the Nivolumab + Daratumumab Cohort

type

PRIMARY

unit Of Measure

Participants

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

Preserved source evidence · Not medical advice