TriangleNCT04398745 · OUTCOME
Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Total Antibody)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Hour
- Interval / dispersion
- Full Range
- 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 (up to Day 30 in C1 and C3)
What was measured
Blood samples were collected for PK analysis of belantamab mafodotin Total Antibody. 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. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.
Analysis population: Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. 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.
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) | 346.9 | Not reported | 23.7 | 579.9 | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 505.5 | Not reported | 334.3 | 528.4 | 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) | 501.3 | Not reported | 334.8 | 697.7 | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 482.5 | Not reported | 335.4 | 505.2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23.7
- upper Limit
- 579.9
- value
- 346.9
- group Id
- OG001
- lower Limit
- 334.3
- upper Limit
- 528.4
- value
- 505.5
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- units
- Participants
- title
- Cycle 1
- categories
- measurements
- group Id
- OG000
- lower Limit
- 334.8
- upper Limit
- 697.7
- value
- 501.3
- group Id
- OG001
- lower Limit
- 335.4
- upper Limit
- 505.2
- value
- 482.5
- 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 Total Antibody. 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. For some participants, dosing in Cycle 2 or Cycle 4 was delayed, resulting in the pre-dose samples in these cycles (C2D1 or C4D1) being collected later than the protocol-defined planned days after dosing in C1D1 or C3D1. Consequently, the last PK samples for these participants were collected outside the pre-defined protocol time points, and certain Tlast values in the data table extend beyond the original protocol-defined Time Frame.
- dispersion Type
- Full Range
- 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
- MEDIAN
- population Description
- Pharmacokinetic Evaluable population. 'Cycle 1' and 'Cycle 3' include the full first and third cycles, along with the Day 1 of Cycle 2 (C2D1) and Cycle 4 (C4D1) Predose periods, respectively. 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.
- 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 (up to Day 30 in C1 and C3)
- title
- Part 1: Time of Last Observed Quantifiable Concentration (Tlast) Following Administration of Belantamab Mafodotin (Total Antibody)
- type
- PRIMARY
- unit Of Measure
- Hour
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice