NCT01592370 · OUTCOME
Number of Participants With Clinical Laboratory Abnormalities by Worst Toxicity Grade in the Nivolumab + Daratumumab Cohort - Thyroid
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 with at Least One On-Treatment TSH Measurement
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 | 38 |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 19 |
|---|
Reported measurements
TSH>ULN
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 | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH > ULN WITH TSH <= ULN AT BASELINE
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 | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN (A)
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
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 | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
WITH FT3/FT4 TEST MISSING
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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH < LLN
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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH < LLN WITH TSH >= LLN AT BASELINE
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 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN
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 |
|---|
TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
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 | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Nivolumab + Daratumumab_Cohort B2 | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
TSH < LLN WITH FT3/FT4 TEST MISSING
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 | 1 | 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
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 3
- title
- TSH>ULN
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 7
- group Id
- OG003
- value
- 2
- title
- TSH > ULN WITH TSH <= ULN AT BASELINE
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- TSH > ULN WITH AT LEAST ONE FT3/FT4 TEST VALUE < LLN (A)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 5
- group Id
- OG003
- value
- 2
- title
- TSH > ULN WITH ALL OTHER FT3/FT4 TEST VALUES >= LLN
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- title
- WITH FT3/FT4 TEST MISSING
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 2
- title
- TSH < LLN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 1
- title
- TSH < LLN WITH TSH >= LLN AT BASELINE
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- TSH < LLN WITH AT LEAST ONE FT3/FT4 TEST VALUE > ULN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 2
- title
- TSH < LLN WITH ALL OTHER FT3/FT4 TEST VALUES <= ULN
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- title
- TSH < LLN WITH FT3/FT4 TEST MISSING
- denoms
- counts
- group Id
- OG000
- value
- 6
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 38
- group Id
- OG003
- value
- 19
- 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 with at Least One On-Treatment TSH Measurement
- 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 - Thyroid
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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