NCT04162210 · OUTCOME
Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) · Source last updated 2026-07-01
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 approximately 263 weeks
What was measured
BCVA score was assessed individually for each eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change from baseline categories are presented for right and left eyes. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from baseline \<0.12 logMAR score; a possible worsened vision was defined as a change from baseline \>=0.12 to \<0.3 logMAR score; a definite worsened vision was defined as a change from baseline \>=0.3 logMAR score. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
Analysis population: Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.
Groups in this outcome
Belantamab Mafodotin
Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
Pomalidomide Plus Dexamethasone
Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
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 |
|---|
| Belantamab Mafodotin | 217 |
|---|
| Pomalidomide Plus Dexamethasone | 102 |
|---|
Reported measurements
Left Eye
Analysis denominator · Participants
| Group | Source count |
|---|
| Belantamab Mafodotin | 203 |
|---|
| Pomalidomide Plus Dexamethasone | 62 |
|---|
>=3 line decrease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 78 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
>=2 but < 3 line decrease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
>=1 but < 2 line decrease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 28 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
<1 line decrease or any increase
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 68 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
Right Eye
Analysis denominator · Participants
| Group | Source count |
|---|
| Belantamab Mafodotin | 203 |
|---|
| Pomalidomide Plus Dexamethasone | 62 |
|---|
>=3 line decrease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 84 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
>=2 but < 3 line decrease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 26 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 4 | Not reported | Not reported | Not reported | Not reported |
|---|
>=1 but < 2 line decrease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 29 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 8 | Not reported | Not reported | Not reported | Not reported |
|---|
<1 line decrease or any increase
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 64 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 45 | Not reported | Not reported | Not reported | Not reported |
|---|
Worst Eye
Analysis denominator · Participants
| Group | Source count |
|---|
| Belantamab Mafodotin | 203 |
|---|
| Pomalidomide Plus Dexamethasone | 62 |
|---|
>=3 line decrease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 98 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
>=2 but < 3 line decrease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
>=1 but < 2 line decrease
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
<1 line decrease or any increase
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Belantamab Mafodotin | 50 | Not reported | Not reported | Not reported | Not reported |
|---|
| Pomalidomide Plus Dexamethasone | 33 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 78
- group Id
- OG001
- value
- 5
- title
- >=3 line decrease
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 6
- title
- >=2 but < 3 line decrease
- measurements
- group Id
- OG000
- value
- 28
- group Id
- OG001
- value
- 10
- title
- >=1 but < 2 line decrease
- measurements
- group Id
- OG000
- value
- 68
- group Id
- OG001
- value
- 41
- title
- <1 line decrease or any increase
- denoms
- counts
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 62
- units
- Participants
- title
- Left Eye
- categories
- measurements
- group Id
- OG000
- value
- 84
- group Id
- OG001
- value
- 5
- title
- >=3 line decrease
- measurements
- group Id
- OG000
- value
- 26
- group Id
- OG001
- value
- 4
- title
- >=2 but < 3 line decrease
- measurements
- group Id
- OG000
- value
- 29
- group Id
- OG001
- value
- 8
- title
- >=1 but < 2 line decrease
- measurements
- group Id
- OG000
- value
- 64
- group Id
- OG001
- value
- 45
- title
- <1 line decrease or any increase
- denoms
- counts
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 62
- units
- Participants
- title
- Right Eye
- categories
- measurements
- group Id
- OG000
- value
- 98
- group Id
- OG001
- value
- 7
- title
- >=3 line decrease
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 7
- title
- >=2 but < 3 line decrease
- measurements
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 15
- title
- >=1 but < 2 line decrease
- measurements
- group Id
- OG000
- value
- 50
- group Id
- OG001
- value
- 33
- title
- <1 line decrease or any increase
- denoms
- counts
- group Id
- OG000
- value
- 203
- group Id
- OG001
- value
- 62
- units
- Participants
- title
- Worst Eye
- denoms
- counts
- group Id
- OG000
- value
- 217
- group Id
- OG001
- value
- 102
- units
- Participants
- description
- BCVA score was assessed individually for each eye. BCVA score was calculated based on the Logarithm of the Minimum Angle of Resolution (logMAR score). Any worst-case change from baseline categories are presented for right and left eyes. BCVA test scores were categorized as no change/improved vision, possible worsened vision and definite worsened vision. No change/improved vision was defined as a change from baseline \<0.12 logMAR score; a possible worsened vision was defined as a change from baseline \>=0.12 to \<0.3 logMAR score; a definite worsened vision was defined as a change from baseline \>=0.3 logMAR score. Baseline (Day 1) was defined as latest pre-dose assessment with non-missing value, including unscheduled visits. Change from Baseline was calculated by subtracting Baseline value from the post-dose visit value.
- groups
- description
- Participants with relapsed/refractory multiple myeloma (RRMM) received 30 minutes intravenous infusion of 2.5 milligram/kilogram (mg/kg) belantamab mafodotin on day 1 of each 21-day cycle
- id
- OG000
- title
- Belantamab Mafodotin
- description
- Participants with RRMM received 4 mg pomalidomide capsule daily on Days 1 to 21 of each 28-day cycle, along with 40 mg or at lower 20 mg (for participants \>75 years of age) dose of dexamethasone tablet once weekly (Days 1, 8, 15 and 22)
- id
- OG001
- title
- Pomalidomide Plus Dexamethasone
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety Population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified categories.
- reporting Status
- POSTED
- time Frame
- Baseline (Day 1) and up to approximately 263 weeks
- title
- Number of Participants With Maximum Worst-case Change From Baseline in Best Corrected Visual Acuity Test (BCVA) Scores
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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