NCT01592370 · OUTCOME
Progression Free Survival Rate
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
- NUMBER
- Unit
- Percentage of Participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to the specified timepoints (up to 48 months)
What was measured
The percentage of participants remaining progression free at the specified timepoints (up to 48 Months)
Analysis population: All Treated Participants with available measurements
Groups in this outcome
Nivolumab Monotherapy (Expansion)
3mg/kg of nivolumab
Nivolumab + Ipilimumab
3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
Nivolumab + Lirilumab
3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
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 Monotherapy (Expansion) | 104 |
|---|
| Nivolumab + Ipilimumab | 65 |
|---|
| Nivolumab + Lirilumab | 72 |
|---|
Reported measurements
2 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab Monotherapy (Expansion) | 0 |
|---|
| Nivolumab + Ipilimumab | 0 |
|---|
| Nivolumab + Lirilumab | 72 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Lirilumab | 58.0 | Not reported | 45.3 | 68.8 | Not reported |
|---|
4 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab Monotherapy (Expansion) | 0 |
|---|
| Nivolumab + Ipilimumab | 0 |
|---|
| Nivolumab + Lirilumab | 72 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Lirilumab | 42.4 | Not reported | 30.4 | 54.0 | Not reported |
|---|
6 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab Monotherapy (Expansion) | 104 |
|---|
| Nivolumab + Ipilimumab | 65 |
|---|
| Nivolumab + Lirilumab | 72 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 50.5 | Not reported | 39.8 | 60.3 | Not reported |
|---|
| Nivolumab + Ipilimumab | 51.5 | Not reported | 38.1 | 63.4 | Not reported |
|---|
| Nivolumab + Lirilumab | 34.3 | Not reported | 23.0 | 45.8 | Not reported |
|---|
9 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab Monotherapy (Expansion) | 0 |
|---|
| Nivolumab + Ipilimumab | 0 |
|---|
| Nivolumab + Lirilumab | 72 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab + Lirilumab | 32.5 | Not reported | 21.4 | 44.0 | Not reported |
|---|
12 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab Monotherapy (Expansion) | 104 |
|---|
| Nivolumab + Ipilimumab | 65 |
|---|
| Nivolumab + Lirilumab | 0 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 34.8 | Not reported | 24.2 | 45.5 | Not reported |
|---|
| Nivolumab + Ipilimumab | 45.3 | Not reported | 32.0 | 57.7 | Not reported |
|---|
18 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab Monotherapy (Expansion) | 104 |
|---|
| Nivolumab + Ipilimumab | 65 |
|---|
| Nivolumab + Lirilumab | 0 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 31.0 | Not reported | 20.7 | 42.0 | Not reported |
|---|
| Nivolumab + Ipilimumab | 40.1 | Not reported | 26.8 | 53.1 | Not reported |
|---|
24 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab Monotherapy (Expansion) | 104 |
|---|
| Nivolumab + Ipilimumab | 65 |
|---|
| Nivolumab + Lirilumab | 0 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 20.3 | Not reported | 11.1 | 31.5 | Not reported |
|---|
| Nivolumab + Ipilimumab | 30.9 | Not reported | 18.0 | 44.9 | Not reported |
|---|
36 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab Monotherapy (Expansion) | 104 |
|---|
| Nivolumab + Ipilimumab | 0 |
|---|
| Nivolumab + Lirilumab | 0 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 15.8 | Not reported | 7.6 | 26.8 | Not reported |
|---|
48 Months
Analysis denominator · Participants
| Group | Source count |
|---|
| Nivolumab Monotherapy (Expansion) | 104 |
|---|
| Nivolumab + Ipilimumab | 0 |
|---|
| Nivolumab + Lirilumab | 0 |
|---|
Values in Percentage of Participants · Interval/dispersion: 95% Confidence Interval| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Nivolumab Monotherapy (Expansion) | 13.2 | Not reported | 5.6 | 24.1 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG002
- lower Limit
- 45.3
- upper Limit
- 68.8
- value
- 58.0
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 72
- units
- Participants
- title
- 2 Months
- categories
- measurements
- group Id
- OG002
- lower Limit
- 30.4
- upper Limit
- 54.0
- value
- 42.4
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 72
- units
- Participants
- title
- 4 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 39.8
- upper Limit
- 60.3
- value
- 50.5
- group Id
- OG001
- lower Limit
- 38.1
- upper Limit
- 63.4
- value
- 51.5
- group Id
- OG002
- lower Limit
- 23.0
- upper Limit
- 45.8
- value
- 34.3
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 65
- group Id
- OG002
- value
- 72
- units
- Participants
- title
- 6 Months
- categories
- measurements
- group Id
- OG002
- lower Limit
- 21.4
- upper Limit
- 44.0
- value
- 32.5
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 72
- units
- Participants
- title
- 9 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.2
- upper Limit
- 45.5
- value
- 34.8
- group Id
- OG001
- lower Limit
- 32.0
- upper Limit
- 57.7
- value
- 45.3
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 65
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 12 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 20.7
- upper Limit
- 42.0
- value
- 31.0
- group Id
- OG001
- lower Limit
- 26.8
- upper Limit
- 53.1
- value
- 40.1
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 65
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 18 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.1
- upper Limit
- 31.5
- value
- 20.3
- group Id
- OG001
- lower Limit
- 18.0
- upper Limit
- 44.9
- value
- 30.9
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 65
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 24 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 7.6
- upper Limit
- 26.8
- value
- 15.8
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 36 Months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 5.6
- upper Limit
- 24.1
- value
- 13.2
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- units
- Participants
- title
- 48 Months
- denoms
- counts
- group Id
- OG000
- value
- 104
- group Id
- OG001
- value
- 65
- group Id
- OG002
- value
- 72
- units
- Participants
- description
- The percentage of participants remaining progression free at the specified timepoints (up to 48 Months)
- dispersion Type
- 95% Confidence Interval
- groups
- description
- 3mg/kg of nivolumab
- id
- OG000
- title
- Nivolumab Monotherapy (Expansion)
- description
- 3 mg/kg of nivolumab and
1 mg/kg of ipilimumab Q3W for 4 doses, followed by nivolumab alone at 3 mg/kg Q2W
- id
- OG001
- title
- Nivolumab + Ipilimumab
- description
- 3 mg/kg of nivolumab Q2W + 3 mg/kg of lirilumab Q4W
- id
- OG002
- title
- Nivolumab + Lirilumab
- param Type
- NUMBER
- population Description
- All Treated Participants with available measurements
- reporting Status
- POSTED
- time Frame
- From randomization to the specified timepoints (up to 48 months)
- title
- Progression Free Survival Rate
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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