TriangleNCT04398745 · OUTCOME
Part 1 and Part 2: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- Baseline (Day 1) and up to approx. 236 weeks
What was measured
Urine samples were collected to assess occult blood and protein in urine by dipstick method. Data is presented as "No Change/Decreased" and "Any Increase" that includes Increase to TRACE, Increase to 1+, Increase to 2+ and Increase to 3+ indicating proportional concentrations in the urine sample. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
Analysis population: Safety population. 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 categories. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
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.
Part 1: Belantamab Mafodotin 2.5 mg/kg (Other 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 other 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.
Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
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 end stage renal disease (ESRD) (not on hemodialysis) 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.
Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
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 ESRD (on hemodialysis) 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) | 5 |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 8 |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function) | 2 |
| Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis) | 5 |
| Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis) | 2 |
Reported measurements
Occult Blood
| Group | Source count |
|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 0 |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 1 |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function) | 0 |
| Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis) | 0 |
| Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis) | 0 |
No Change/Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis) | 0 | Not reported | Not reported | Not reported | Not reported |
Any Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis) | 0 | Not reported | Not reported | Not reported | Not reported |
Protein
| Group | Source count |
|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 5 |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 8 |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function) | 2 |
| Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis) | 5 |
| Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis) | 2 |
No Change/Decreased
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 5 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis) | 4 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis) | 2 | Not reported | Not reported | Not reported | Not reported |
Any Increase
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Normal/Mildly Impaired Renal Function) | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Severely Impaired Renal Function) | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Belantamab Mafodotin 2.5 mg/kg (Other Renal Function) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- No Change/Decreased
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- title
- Any Increase
- denoms
- counts
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- units
- Participants
- title
- Occult Blood
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 4
- group Id
- OG004
- value
- 2
- title
- No Change/Decreased
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- group Id
- OG004
- value
- 0
- title
- Any Increase
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 2
- units
- Participants
- title
- Protein
- denoms
- counts
- group Id
- OG000
- value
- 5
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 5
- group Id
- OG004
- value
- 2
- units
- Participants
- description
- Urine samples were collected to assess occult blood and protein in urine by dipstick method. Data is presented as "No Change/Decreased" and "Any Increase" that includes Increase to TRACE, Increase to 1+, Increase to 2+ and Increase to 3+ indicating proportional concentrations in the urine sample. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Worst Case Post-Baseline includes all scheduled and unscheduled visits post baseline.
- 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)
- 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 other 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
- OG002
- title
- Part 1: Belantamab Mafodotin 2.5 mg/kg (Other 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 end stage renal disease (ESRD) (not on hemodialysis) 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
- OG003
- title
- Part 2: Belantamab Mafodotin 2.5 mg/kg End Stage Renal Disease (Not on Dialysis)
- 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 ESRD (on hemodialysis) 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
- OG004
- title
- Part 2: Belantamab Mafodotin 2.5 mg/kg ESRD (On Dialysis)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety population. 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 categories. The "0" participants analyzed represents that data was not collected or available for analysis at that particular time point for the respective Arms/Groups.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to approx. 236 weeks
- title
- Part 1 and Part 2: Number of Participants With Worst Case Urinalysis Results Post-Baseline Relative to Baseline
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice