NCT03848845 · OUTCOME
Part 1 - C-EOI for Total mAb
Study Evaluating Safety, Tolerability and Clinical Activity of GSK2857916 in Combination With Pembrolizumab in Subjects With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2024-04-09
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- ug/mL
- Interval / dispersion
- Full Range
- Time frame
- EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, Cycle 5, Cycle 8, and Cycle 11
What was measured
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
Analysis population: Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
Groups in this outcome
Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation
Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.
Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
Participants were administered 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.
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 |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 4 |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 7 |
|---|
Reported measurements
Cycle 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 4 |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 7 |
|---|
Values in ug/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 40.15 | Not reported | 36.3 | 44.4 | Not reported |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 65.30 | Not reported | 44.6 | 73.5 | Not reported |
|---|
Cycle 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 4 |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 4 |
|---|
Values in ug/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 53.90 | Not reported | 39.1 | 66.3 | Not reported |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 64.65 | Not reported | 16.1 | 90.1 | Not reported |
|---|
Cycle 5
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 4 |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 3 |
|---|
Values in ug/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 54.65 | Not reported | 46.5 | 78.2 | Not reported |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 73.90 | Not reported | 42.6 | 101.0 | Not reported |
|---|
Cycle 8
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 1 |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 2 |
|---|
Values in ug/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 63.70 | Not reported | 63.70 | 63.70 | Not reported |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 39.75 | Not reported | 12.9 | 66.6 | Not reported |
|---|
Cycle 11
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 1 |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 1 |
|---|
Values in ug/mL · Interval/dispersion: Full Range| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 65.40 | Not reported | 65.40 | 65.40 | Not reported |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 54.80 | Not reported | 54.80 | 54.80 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 36.3
- upper Limit
- 44.4
- value
- 40.15
- group Id
- OG001
- lower Limit
- 44.6
- upper Limit
- 73.5
- value
- 65.30
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 39.1
- upper Limit
- 66.3
- value
- 53.90
- group Id
- OG001
- lower Limit
- 16.1
- upper Limit
- 90.1
- value
- 64.65
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- Cycle 2
- categories
- measurements
- group Id
- OG000
- lower Limit
- 46.5
- upper Limit
- 78.2
- value
- 54.65
- group Id
- OG001
- lower Limit
- 42.6
- upper Limit
- 101.0
- value
- 73.90
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 3
- units
- Participants
- title
- Cycle 5
- categories
- measurements
- group Id
- OG000
- lower Limit
- 63.70
- upper Limit
- 63.70
- value
- 63.70
- group Id
- OG001
- lower Limit
- 12.9
- upper Limit
- 66.6
- value
- 39.75
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Cycle 8
- categories
- measurements
- group Id
- OG000
- lower Limit
- 65.40
- upper Limit
- 65.40
- value
- 65.40
- group Id
- OG001
- lower Limit
- 54.80
- upper Limit
- 54.80
- value
- 54.80
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Cycle 11
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. PK parameter was determined using standard non-compartmental methods.
- dispersion Type
- Full Range
- groups
- description
- Participants were administered 2.5 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.
- id
- OG000
- title
- Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation
- description
- Participants were administered 3.4 mg/kg of belantamab mafodotin in combination with 200 mg of pembrolizumab via intravenous (IV) infusion on Day 1 of each 21-day Cycle up to until disease progression, intolerable toxicity, informed consent withdrawal , or for a maximum of 35 cycles.
- id
- OG001
- title
- Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation
- param Type
- MEDIAN
- population Description
- Pharmacokinetic Population. Only those participants with data available at specified time points have been analyzed.
- reporting Status
- POSTED
- time Frame
- EOI post belantamab mafodotin dose on Day 1 of Cycle 1, Cycle 2, Cycle 5, Cycle 8, and Cycle 11
- title
- Part 1 - C-EOI for Total mAb
- type
- SECONDARY
- unit Of Measure
- ug/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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