NCT03828292 · OUTCOME
Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
An Open-label, Dose Escalation Study in Japanese Participants With Relapsed/Refractory Multiple Myeloma Who Have Failed Prior Anti Myeloma Treatments · Source last updated 2025-08-19
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 3, Cycle 6, Cycle 9 and Cycle 12
What was measured
Blood samples were collected for PK analysis. 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 - 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 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 - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 4 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 4 |
|---|
Reported measurements
CYCLE 1
Analysis denominator · Participants
| 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 |
|---|
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 30.28 | 24.32 | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 39.42 | 14.15 | Not reported | Not reported | Not reported |
|---|
CYCLE 2
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 3 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 2 |
|---|
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 32.52 | 14.13 | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 31.44 | 58.71 | Not reported | Not reported | Not reported |
|---|
CYCLE 3
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 2 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 1 |
|---|
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 23.25 | 20.83 | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 32.20 | Not reported | Not reported | Not reported | Not reported |
|---|
CYCLE 6
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 1 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 2 |
|---|
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 23.60 | Not reported | Not reported | Not reported | Not reported |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 29.22 | 24.69 | Not reported | Not reported | Not reported |
|---|
CYCLE 9
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 1 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 0 |
|---|
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 24.50 | Not reported | Not reported | Not reported | Not reported |
|---|
CYCLE 12
Analysis denominator · Participants
| Group | Source count |
|---|
| Main Study - Part 1: Belantamab Mafodotin 2.5 Milligram/ Kilogram (mg/kg) | 0 |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 1 |
|---|
Values in ug/mL · Interval/dispersion: Geometric Coefficient of Variation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Main Study - Part 1: Belantamab Mafodotin 3.4 mg/kg | 34.50 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 24.32
- value
- 30.28
- group Id
- OG001
- spread
- 14.15
- value
- 39.42
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 4
- units
- Participants
- title
- CYCLE 1
- categories
- measurements
- group Id
- OG000
- spread
- 14.13
- value
- 32.52
- group Id
- OG001
- spread
- 58.71
- value
- 31.44
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- CYCLE 2
- categories
- measurements
- group Id
- OG000
- spread
- 20.83
- value
- 23.25
- group Id
- OG001
- value
- 32.20
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- CYCLE 3
- categories
- measurements
- group Id
- OG000
- value
- 23.60
- group Id
- OG001
- spread
- 24.69
- value
- 29.22
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 2
- units
- Participants
- title
- CYCLE 6
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- units
- Participants
- title
- CYCLE 9
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- units
- Participants
- title
- CYCLE 12
- 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. Only those participants with data available at specified time points have been analyzed.
- reporting Status
- POSTED
- time Frame
- Cycle 1, Cycle 2, Cycle 3, Cycle 6, Cycle 9 and Cycle 12
- title
- Part 1: Concentration at the End of Infusion (C-EOI) Following Repeat Dose Administration of Belantamab Mafodotin (ADC)
- type
- SECONDARY
- unit Of Measure
- ug/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
Triangle