NCT01592370 · OUTCOME
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology
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
Hemoglobin
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 | 21 |
|---|
Grade 0
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 20 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Platelet count
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 | 21 |
|---|
Grade 0
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 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 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Leukocytes
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 | 21 |
|---|
Grade 0
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 | 0 | 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 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Lymphocytes (Absolute)
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 | 21 |
|---|
Grade 0
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 1
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
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 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Absolute Neutrophil Count
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 |
|---|
Grade 0
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 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 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 2
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 3
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Grade 4
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Daratumumab_Cohort A1 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort A2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B1 | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 1
- title
- Grade 0
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 13
- title
- Grade 1
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 20
- group Id
- OG003
- value
- 5
- title
- Grade 2
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 21
- units
- Participants
- title
- Hemoglobin
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 19
- group Id
- OG003
- value
- 8
- title
- Grade 0
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 9
- title
- Grade 1
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- title
- Grade 2
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 1
- title
- Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 21
- units
- Participants
- title
- Platelet count
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 5
- title
- Grade 0
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 9
- title
- Grade 1
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 5
- title
- Grade 2
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 2
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 21
- units
- Participants
- title
- Leukocytes
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 3
- title
- Grade 0
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 5
- title
- Grade 1
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 7
- title
- Grade 2
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 15
- group Id
- OG003
- value
- 5
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- title
- Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 21
- units
- Participants
- title
- Lymphocytes (Absolute)
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 10
- title
- Grade 0
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 6
- title
- Grade 1
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 6
- title
- Grade 2
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 9
- group Id
- OG003
- value
- 0
- title
- Grade 3
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 0
- title
- Grade 4
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 41
- group Id
- OG003
- value
- 22
- units
- Participants
- title
- Absolute Neutrophil Count
- 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 With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Hematology
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
Triangle