NCT07217119 · OUTCOME
DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
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 approximately 281 weeks.
What was measured
Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] were assessed by the investigator per IMWG (2016). PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
Analysis population: Safety population
Groups in this outcome
1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab
Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
| Group | Source count |
|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 9 |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 10 |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 6 |
Reported measurements
Stringent Complete Response (sCR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 0 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 10 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 0 | Not reported | Not reported | Not reported | Not reported |
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 11 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 0 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 17 | Not reported | Not reported | Not reported | Not reported |
Very Good Partial Response (VGPR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 22 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 40 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 33 | Not reported | Not reported | Not reported | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 11 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab | 0 | Not reported | Not reported | Not reported | Not reported |
| 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab | 17 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 0
- title
- Stringent Complete Response (sCR)
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 17
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- value
- 22
- group Id
- OG001
- value
- 40
- group Id
- OG002
- value
- 33
- title
- Very Good Partial Response (VGPR)
- categories
- measurements
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 17
- title
- Partial Response (PR)
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 6
- units
- Participants
- description
- Partial Response \[PR\], Very Good Partial Response \[VGPR\], Complete Response \[CR\], and stringent Complete Response \[sCR\] were assessed by the investigator per IMWG (2016). PR defined as ≥50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by ≥90% or to \<200 mg/24 h. VGPR defined as serum and urine M-component detectable by immunofixation but not on electrophoresis OR ≥ 90% reduction in serum M-component plus urine M-component \<100 mg/24 h. CR defined as negative immunofixation of serum and urine AND disappearance of any soft tissue plasmacytomas AND \<5% plasmacytomas in the bone marrow. sCR defined as CR as above PLUS normal serum free light-chain (FLC) assay ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
- groups
- description
- Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin end of infusion (EOI), once every 3 weeks (Q3W).
- id
- OG000
- title
- 1.9 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
- description
- Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 8 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
- id
- OG001
- title
- 2.5 mg/kg Belantamab Mafodotin + 8 mg Feladilimab
- description
- Participants with RRMM received 2.5 mg/kg belantamab mafodotin IV infusion in combination with 24 mg feladilimab IV infusion, given 1 hour after belantamab mafodotin EOI Q3W.
- id
- OG002
- title
- 2.5 mg/kg Belantamab Mafodotin + 24 mg Feladilimab
- param Type
- NUMBER
- population Description
- Safety population
- reporting Status
- POSTED
- time Frame
- Up to approximately 281 weeks.
- title
- DE Phase: Percentage of Participants Achieving Stringent Complete Response (SCR), Complete Response (CR), Very Good Partial Response (VGPR) and Partial Response (PR)
- type
- SECONDARY
- unit Of Measure
- Percentage of Participants
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Preserved source evidence · Not medical advice
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