NCT03848845 · OUTCOME
Part 1 - Ctrough 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
- Cycle 1, Cycle 4, Cycle 7, Cycle 10, and Cycle 13
What was measured
Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. 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 | 5 |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 4 |
|---|
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 | 3 |
|---|
| 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 | 5.420 | Not reported | 3.85 | 7.87 | Not reported |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 13.350 | Not reported | 1.83 | 13.50 | Not reported |
|---|
Cycle 4
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 5 |
|---|
| 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 | 8.91 | Not reported | 0 | 30.8 | Not reported |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 18.80 | Not reported | 18.1 | 19.5 | Not reported |
|---|
Cycle 7
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 | 26.90 | Not reported | 26.9 | 26.9 | Not reported |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 45.05 | Not reported | 23.9 | 66.2 | Not reported |
|---|
Cycle 10
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 | 18.40 | Not reported | 18.4 | 18.4 | Not reported |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 21.70 | Not reported | 21.7 | 21.7 | Not reported |
|---|
Cycle 13
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study Phase- Part 1: Belantamab Mafodotin 2.5 mg/kg + Pembrolizumab 200 mg Escalation | 2 |
|---|
| Part 1: Belantamab Mafodotin 3.4 mg/kg + Pembrolizumab 200 mg Escalation | 0 |
|---|
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 | 18.05 | Not reported | 18.0 | 18.1 | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 3.85
- upper Limit
- 7.87
- value
- 5.420
- group Id
- OG001
- lower Limit
- 1.83
- upper Limit
- 13.50
- value
- 13.350
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 30.8
- value
- 8.91
- group Id
- OG001
- lower Limit
- 18.1
- upper Limit
- 19.5
- value
- 18.80
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Cycle 4
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26.9
- upper Limit
- 26.9
- value
- 26.90
- group Id
- OG001
- lower Limit
- 23.9
- upper Limit
- 66.2
- value
- 45.05
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- Cycle 7
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.4
- upper Limit
- 18.4
- value
- 18.40
- group Id
- OG001
- lower Limit
- 21.7
- upper Limit
- 21.7
- value
- 21.70
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- Cycle 10
- categories
- measurements
- group Id
- OG000
- lower Limit
- 18.0
- upper Limit
- 18.1
- value
- 18.05
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- Cycle 13
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Blood samples were collected for PK analysis of belantamab mafodotin when administered intravenously in combination with pembrolizumab. Ctrough was calculated as the observed concentration at the end of a dosing interval, immediately before next study drug administration on Day 1 of each Cycle. 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
- Cycle 1, Cycle 4, Cycle 7, Cycle 10, and Cycle 13
- title
- Part 1 - Ctrough for Total mAb
- type
- SECONDARY
- unit Of Measure
- ug/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
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