TriangleNCT04398745 · OUTCOME
Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration 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
- hour*microgram/millitre(h*ug/mL)
- Interval / dispersion
- Geometric Coefficient of Variation
- Time frame
- Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.
What was measured
Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
Analysis population: Pharmacokinetic Evaluable population included all participants in the safety analysis set who had at least 80% non-missing expected plasma PK data during the Cycle 1 profile (i.e., all Cycle 1 timepoints and Cycle 2 Day 1 pre-dose). 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively.
Groups in this outcome
Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
| Group | Source count |
|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 8 |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 8 |
Reported measurements
Cycle 1
| Group | Source count |
|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 8 |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 8 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 4021.3 | 54.3 | Not reported | Not reported | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 3704.7 | 32.4 | Not reported | Not reported | Not reported |
Cycle 3
| Group | Source count |
|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 3 |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 5 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 6729.9 | 32.1 | Not reported | Not reported | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 4127.8 | 30.4 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 54.3
- value
- 4021.3
- group Id
- OG001
- spread
- 32.4
- value
- 3704.7
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- spread
- 32.1
- value
- 6729.9
- group Id
- OG001
- spread
- 30.4
- value
- 4127.8
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- units
- Participants
- title
- Cycle 3
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- Blood samples were collected for PK analysis of belantamab mafodotin ADC. As pre-specified in protocol, only specified treatment arms were planned to be analyzed for this outcome measure. As first dose of belantamab mafodotin was administered on Day 1, cycle length correlates to Day 1 plus 21 days i.e., Day 22 in timeframe. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints.
- dispersion Type
- Geometric Coefficient of Variation
- groups
- description
- Participants with Relapsed/Refractory Multiple Myeloma (RRMM) who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and normal/mildly impaired renal function received intravenous (IV) infusion of 2.5 milligram (mg)/kilogram (kg) belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to adverse event (AE), lost to follow-up, death, whichever occurs first.
- id
- OG000
- title
- Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function)
- description
- Participants with RRMM who have had at least 3 lines of prior treatment (or at least 2 lines of prior treatment if ineligible for autologous stem cell transplantation) and severe renal impairment renal function received IV infusion of 2.5 mg/kg belantamab mafodotin for 30 minutes on Day 1 of every 21-day Cycle until disease progression, withdrawal of consent, withdrawal due to AE, lost to follow-up, death, whichever occurs first.
- id
- OG001
- title
- Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function)
- param Type
- GEOMETRIC_MEAN
- population Description
- Pharmacokinetic Evaluable population included all participants in the safety analysis set who had at least 80% non-missing expected plasma PK data during the Cycle 1 profile (i.e., all Cycle 1 timepoints and Cycle 2 Day 1 pre-dose). 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively.
- reporting Status
- POSTED
- time Frame
- Pre-dose, end of infusion (EOI), start of infusion (SOI)+2hour (h), SOI+4h, SOI+8h and SOI+24h on Cycle(C) 1 Day(D) 1 and C3D1; Anytime on C1 D4, D8, D15, D22; Anytime on C3 D4, D8, D15, D22; Pre-dose on C2D1 and C4D1.
- title
- Part 1: Area Under the Concentration-time Curve to Last Quantifiable Timepoint (AUC(0-tlast)) Following Administration of Belantamab Mafodotin (Antibody-drug Conjugate (ADC))
- type
- PRIMARY
- unit Of Measure
- hour*microgram/millitre(h*ug/mL)
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Preserved source evidence · Not medical advice