TriangleNCT05064358 · OUTCOME
Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- Not reported
- Time frame
- Up to 29.5 months
What was measured
The KVA scale is based on the evaluation of corneal changes using slit lamp examination. This scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
Analysis population: Safety Population included all randomized participants who received at least 1 dose of study treatment. As outlined in the protocol, the objective was to examine the corneal events in Arms B to D, compared to Arm A; hence, Arm E was not included.
Groups in this outcome
Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
| Group | Source count |
|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 39 |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 40 |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 39 |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 40 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W) | 64 | Not reported | Not reported | Not reported | Not reported |
| Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W | 40 | Not reported | Not reported | Not reported | Not reported |
| Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W) | 44 | Not reported | Not reported | Not reported | Not reported |
| Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W | 38 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 44
- group Id
- OG003
- value
- 38
- denoms
- counts
- group Id
- OG000
- value
- 39
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 39
- group Id
- OG003
- value
- 40
- units
- Participants
- description
- The KVA scale is based on the evaluation of corneal changes using slit lamp examination. This scale provides a standardized approach for evaluating the relationship between corneal health and visual acuity. KVA scale is defined as Grade 0: No keratopathy, normal visual acuity with no corneal abnormalities; Grade 1: Mild changes to the cornea with no significant loss in visual acuity; Grade 2: Moderate corneal changes with noticeable visual acuity reduction; Grade 3: Severe corneal changes with substantial visual acuity impairment; Grade 4: Very severe corneal changes leading to significant vision loss. Higher grade indicates greater severity of corneal events.
- groups
- description
- Participants with Relapsed or Refractory Multiple Myeloma (RRMM) received belantamab mafodotin as 2.5 milligram (mg)/kilogram (kg) dose on Day 1 of every 3 weeks (Q3W) as a 30-60 minute intravenous (IV) infusion until confirmed disease progression, unacceptable toxicity or death.
- id
- OG000
- title
- Arm A: Belantamab Mafodotin 2.5 Milligram (mg)/Kilogram (kg) Every 3 Weeks (Q3W)
- description
- Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q3W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
- id
- OG001
- title
- Arm B: Belantamab Mafodotin 1.9 mg/kg Q3W
- description
- Participants with RRMM received belantamab mafodotin as 2.5 mg/kg dose on Day 1 of every 6 weeks (Q6W) as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
- id
- OG002
- title
- Arm C: Belantamab Mafodotin 2.5 mg/kg Every 6 Weeks (Q6W)
- description
- Participants with RRMM received belantamab mafodotin as 1.9 mg/kg dose on Day 1 of Q6W as a 30-60 minute IV infusion until confirmed disease progression, unacceptable toxicity or death.
- id
- OG003
- title
- Arm D: Belantamab Mafodotin 1.9 mg/kg Q6W
- param Type
- NUMBER
- population Description
- Safety Population included all randomized participants who received at least 1 dose of study treatment. As outlined in the protocol, the objective was to examine the corneal events in Arms B to D, compared to Arm A; hence, Arm E was not included.
- reporting Status
- POSTED
- time Frame
- Up to 29.5 months
- title
- Percentage of Participants With Grade ≥2 Corneal Events Assessed by Keratopathy Visual Acuity (KVA) Scale
- type
- PRIMARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice