NCT01592370 · OUTCOME
Time to MRD Negativity Status 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
- Months
- Interval / dispersion
- Standard Deviation
- Time frame
- approximately up to 4 years
What was measured
Time to MRD Negativity status in specific NGS and NGF sensitivity levels
Analysis population: All Randomized MRD Evaluable Subjects Achieving MRD Negativity
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 | 1 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 6 |
|---|
| Cohort B-2 | 4 |
|---|
Reported measurements
NGS sensitivity level=10e-4
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 1 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 6 |
|---|
| Cohort B-2 | 1 |
|---|
Values in Months · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A-1 | 3.02 | NA | Not reported | Not reported | SD not calculable with 1 participant |
|---|
| Cohort B-1 | 3.60 | 2.409 | Not reported | Not reported | Not reported |
|---|
| Cohort B-2 | 2.83 | NA | Not reported | Not reported | SD not calculable with 1 participant |
|---|
NGS sensitivity level=10e-5
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 1 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 6 |
|---|
| Cohort B-2 | 0 |
|---|
Values in Months · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A-1 | 3.02 | NA | Not reported | Not reported | SD not calculable with 1 participant |
|---|
| Cohort B-1 | 5.45 | 4.788 | Not reported | Not reported | Not reported |
|---|
NGS sensitivity level=10e-6
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 1 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 0 |
|---|
| Cohort B-2 | 0 |
|---|
Values in Months · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort A-1 | 30.85 | NA | Not reported | Not reported | SD not calculable with 1 participant |
|---|
NGF sensitivity level=10e-4
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 0 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 4 |
|---|
| Cohort B-2 | 4 |
|---|
Values in Months · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort B-1 | 2.94 | 0.230 | Not reported | Not reported | Not reported |
|---|
| Cohort B-2 | 4.20 | 2.766 | Not reported | Not reported | Not reported |
|---|
NGF sensitivity level=10e-5
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 0 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 3 |
|---|
| Cohort B-2 | 0 |
|---|
Values in Months · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort B-1 | 6.97 | 6.776 | Not reported | Not reported | Not reported |
|---|
NGF sensitivity level=10e-6
Analysis denominator · Participants
| Group | Source count |
|---|
| Cohort A-1 | 0 |
|---|
| Cohort A-2 | 0 |
|---|
| Cohort B-1 | 2 |
|---|
| Cohort B-2 | 0 |
|---|
Values in Months · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cohort B-1 | 12.30 | 3.508 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- SD not calculable with 1 participant
- group Id
- OG000
- spread
- NA
- value
- 3.02
- group Id
- OG002
- spread
- 2.409
- value
- 3.60
- comment
- SD not calculable with 1 participant
- group Id
- OG003
- spread
- NA
- value
- 2.83
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 1
- units
- Participants
- title
- NGS sensitivity level=10e-4
- categories
- measurements
- comment
- SD not calculable with 1 participant
- group Id
- OG000
- spread
- NA
- value
- 3.02
- group Id
- OG002
- spread
- 4.788
- value
- 5.45
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- NGS sensitivity level=10e-5
- categories
- measurements
- comment
- SD not calculable with 1 participant
- group Id
- OG000
- spread
- NA
- value
- 30.85
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- NGS sensitivity level=10e-6
- categories
- measurements
- group Id
- OG002
- spread
- 0.230
- value
- 2.94
- group Id
- OG003
- spread
- 2.766
- value
- 4.20
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 4
- units
- Participants
- title
- NGF sensitivity level=10e-4
- categories
- measurements
- group Id
- OG002
- spread
- 6.776
- value
- 6.97
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- NGF sensitivity level=10e-5
- categories
- measurements
- group Id
- OG002
- spread
- 3.508
- value
- 12.30
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- units
- Participants
- title
- NGF sensitivity level=10e-6
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 6
- group Id
- OG003
- value
- 4
- units
- Participants
- description
- Time to MRD Negativity status in specific NGS and NGF sensitivity levels
- 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 Randomized MRD Evaluable Subjects Achieving MRD Negativity
- reporting Status
- POSTED
- time Frame
- approximately up to 4 years
- title
- Time to MRD Negativity Status in the Nivolumab + Daratumumab Cohort
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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