TriangleNCT04177823 · OUTCOME
Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC[0-t]) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- GEOMETRIC_MEAN
- Unit
- Hours*microgram per milliliter (h*ug/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)
What was measured
Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. AUC\[0-t\] was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.
Analysis population: Pharmacokinetic (PK) population, was defined as those participants in the "All treated" population from whom at least one PK sample was obtained, analyzed, and was measurable.
Groups in this outcome
Belantamab Mafodotin
Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
| Group | Source count |
|---|---|
| Belantamab Mafodotin | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Belantamab Mafodotin | 2819.39 | 30.32 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 30.32
- value
- 2819.39
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- Blood samples were collected at indicated time points for pharmacokinetic analysis of belantamab mafodotin. PK parameters were analyzed using standard non-compartmental analysis. AUC\[0-t\] was calculated using the linear trapezoidal rule for each incremental trapezoid and the log trapezoidal rule for each decremental trapezoid.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with relapsed/refractory multiple myeloma (RRMM) were administered with 2.5 milligram per kilogram (mg/kg) belantamab mafodotin intravenous (IV) infusion over 30-60 minutes on day 1 of each 21-days cycle. Participants were treated until disease progression, intolerable toxicity, end of study or informed consent withdrawal.
- id
- OG000
- title
- Belantamab Mafodotin
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic (PK) population, was defined as those participants in the "All treated" population from whom at least one PK sample was obtained, analyzed, and was measurable.
- reporting Status
- POSTED
- time Frame
- Pre-dose (within 30 minutes prior to start of infusion), end of infusion (EOI), 2, 4, 8 and 24 hours post start of infusion (HPS) on day 1, anytime on day 2, 4, 8, 15 and 22 of cycle 1 (each cycle is of 21 days)
- title
- Area Under the Plasma Concentration-time Curve From Time Zero to Time of the Last Quantifiable Concentration (AUC[0-t]) of Belantamab Mafodotin Antibody-drug Conjugate (ADC)
- type
- SECONDARY
- unit Of Measure
- Hours*microgram per milliliter (h*ug/mL)
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice