TriangleNCT03828292 · OUTCOME
Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- ug/mL
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11
What was measured
Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
Analysis population: Pharmacokinetic population.
Groups in this outcome
Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
| Group | Source count |
|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 4 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | NA | NA | Not reported | Not reported | Due to shorter half-life of cys-mcMMAF, the concentration values were below the Lower Limit of Quantification (LLOQ). Hence, Ctrough values were not determined. |
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | NA | NA | Not reported | Not reported | Due to shorter half-life of cys-mcMMAF, the concentration values were below the Lower Limit of Quantification (LLOQ). Hence, Ctrough values were not determined. |
Complete source fields
- classes
- categories
- measurements
- comment
- Due to shorter half-life of cys-mcMMAF, the concentration values were below the Lower Limit of Quantification (LLOQ). Hence, Ctrough values were not determined.
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Due to shorter half-life of cys-mcMMAF, the concentration values were below the Lower Limit of Quantification (LLOQ). Hence, Ctrough values were not determined.
- group Id
- OG001
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- units
- Participants
- description
- Blood samples were collected for PK analysis. PK parameter was determined using standard non-compartmental methods.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose via intravenous (IV) infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
- id
- OG000
- title
- Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg)
- description
- Participants with RRMM received belantamab mafodotin as dose of 3.4 mg/kg via IV infusion on Day 1 of every 21-day cycle (Q3W) maximum up to disease progression.
- id
- OG001
- title
- Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic population.
- reporting Status
- POSTED
- time Frame
- Cycle 1, Cycle 2, Cycle 5, Cycle 8 and Cycle 11
- title
- Part 1: Ctrough Following Repeat Dose Administration of Belantamab Mafodotin (Cys-mcMMAF)
- type
- SECONDARY
- unit Of Measure
- ug/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice