NCT01592370 · OUTCOME
End of Infusion Nivolumab Concentration Levels 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
- MEAN
- Unit
- ug/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days
What was measured
Serum concentration achieved at the end of study drug infusion
Analysis population: All treated participants in the nivo dara cohort - pharmacokinetic subset
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 | 5 |
|---|
| Cohort B-1 | 41 |
|---|
| Cohort B-2 | 0 |
|---|
Reported measurements
Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 5 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 32 |
|---|
| Cohort B-2 | 0 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A-1 | 57.28 | 6.78 | Not reported | Not reported | Not reported |
|---|
| Cohort B-1 | 69.59 | 18.79 | Not reported | Not reported | Not reported |
|---|
Cycle 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 0 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 21 |
|---|
| Cohort B-2 | 0 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort B-1 | 175.73 | 88.94 | Not reported | Not reported | Not reported |
|---|
Cycle 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 5 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 6 |
|---|
| Cohort B-2 | 0 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A-1 | 105.14 | 31.41 | Not reported | Not reported | Not reported |
|---|
| Cohort B-1 | 193.38 | 69.74 | Not reported | Not reported | Not reported |
|---|
Cycle 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 0 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 21 |
|---|
| Cohort B-2 | 0 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort B-1 | 208.14 | 58.38 | Not reported | Not reported | Not reported |
|---|
Cycle 7
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 4 |
|---|
| Cohort A-2 | 1 |
|---|
| Cohort B-1 | 3 |
|---|
| Cohort B-2 | 0 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A-1 | 227.75 | 26.79 | Not reported | Not reported | Not reported |
|---|
| Cohort A-2 | 206.00 | NA | Not reported | Not reported | Not calculable with only 1 participant |
|---|
| Cohort B-1 | 193.00 | 70.06 | Not reported | Not reported | Not reported |
|---|
Cycle 11
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 0 |
|---|
| Cohort A-2 | 1 |
|---|
| Cohort B-1 | 3 |
|---|
| Cohort B-2 | 0 |
|---|
Values in ug/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A-2 | 206.00 | NA | Not reported | Not reported | Not calculable with only 1 participant |
|---|
| Cohort B-1 | 212.00 | 38.20 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 6.78
- value
- 57.28
- group Id
- OG002
- spread
- 18.79
- value
- 69.59
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 32
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG002
- spread
- 88.94
- value
- 175.73
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Cycle 2
- categories
- measurements
- group Id
- OG000
- spread
- 31.41
- value
- 105.14
- group Id
- OG002
- spread
- 69.74
- value
- 193.38
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Cycle 3
- categories
- measurements
- group Id
- OG002
- spread
- 58.38
- value
- 208.14
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 21
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Cycle 5
- categories
- measurements
- group Id
- OG000
- spread
- 26.79
- value
- 227.75
- comment
- Not calculable with only 1 participant
- group Id
- OG001
- spread
- NA
- value
- 206.00
- group Id
- OG002
- spread
- 70.06
- value
- 193.00
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Cycle 7
- categories
- measurements
- comment
- Not calculable with only 1 participant
- group Id
- OG001
- spread
- NA
- value
- 206.00
- group Id
- OG002
- spread
- 38.20
- value
- 212.00
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- Cycle 11
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 0
- units
- Participants
- description
- Serum concentration achieved at the end of study drug infusion
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- All treated participants in the nivo dara cohort - pharmacokinetic subset
- reporting Status
- POSTED
- time Frame
- Measurements collected at cycles 1, 2, 3, 5, 7, and 11; each cycle is 28 days
- title
- End of Infusion Nivolumab Concentration Levels in the Nivolumab + Daratumumab Cohort
- type
- SECONDARY
- unit Of Measure
- ug/mL
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle