TriangleNCT05014412 · OUTCOME
Number of Participants With Adverse Events of Special Interest (AESI)- CRS and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) [All Causalities and Treatment Related]: Parts 1 and 2
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
- Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)
What was measured
CRS and ICANS were assessed according to ASTCT criteria. ASTCT for ICANS: Grade 1 \[immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition) score 7-9, awakens spontaneously\]; Grade 2 \[ICE score 3-6, awakens to voice\]; Grade 3 \[ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on EEG that resolve with intervention, focal/local oedema on neuroimaging\]; Grade 4 \[ICE 0 (unarousable and unable to perform ICE), Unarousable or requires vigorous or repetitive tactile stimuli to arouse. Stupor or coma, Life-threatening prolonged seizure (\>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, Diffuse cerebral oedema on neuroimaging; decerebrate or decorticate posturing; or cranial nerve VI (abducens nerve) palsy; or papilledema; or Cushing's triad\].
Analysis population: Safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
Groups in this outcome
Part 1
Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 6 cycles. Thereafter, participants with PR or better response persisting for \>= 2 months on QW received 76 mg every Q2W and/or 116 mg or 152 mg Q4W from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Part 2A: Dose Level 1
Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Part 2A: Dose Level 2
Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
Part 2B
Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
| Group | Source count |
|---|---|
| Part 1 | 33 |
| Part 2A: Dose Level 1 | 12 |
| Part 2A: Dose Level 2 | 11 |
| Part 2B | 29 |
Reported measurements
All cause: CRS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 20 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 14 | Not reported | Not reported | Not reported | Not reported |
All cause: ICANS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 0 | Not reported | Not reported | Not reported | Not reported |
Treatment related: CRS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 20 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 10 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 13 | Not reported | Not reported | Not reported | Not reported |
Treatment related: ICANS
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Part 2B | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 14
- title
- All cause: CRS
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- title
- All cause: ICANS
- categories
- measurements
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 10
- group Id
- OG003
- value
- 13
- title
- Treatment related: CRS
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 0
- title
- Treatment related: ICANS
- denoms
- counts
- group Id
- OG000
- value
- 33
- group Id
- OG001
- value
- 12
- group Id
- OG002
- value
- 11
- group Id
- OG003
- value
- 29
- units
- Participants
- description
- CRS and ICANS were assessed according to ASTCT criteria. ASTCT for ICANS: Grade 1 \[immune effector cell-associated encephalopathy (ICE, overall score range 0-10, higher score = better condition) score 7-9, awakens spontaneously\]; Grade 2 \[ICE score 3-6, awakens to voice\]; Grade 3 \[ICE score 0-2, awakens only to tactile stimulus, any clinical seizure that resolves rapidly or non-convulsive seizures on EEG that resolve with intervention, focal/local oedema on neuroimaging\]; Grade 4 \[ICE 0 (unarousable and unable to perform ICE), Unarousable or requires vigorous or repetitive tactile stimuli to arouse. Stupor or coma, Life-threatening prolonged seizure (\>5 min); or repetitive clinical or electrical seizures without return to baseline in between, deep focal motor weakness such as hemiparesis or paraparesis, Diffuse cerebral oedema on neuroimaging; decerebrate or decorticate posturing; or cranial nerve VI (abducens nerve) palsy; or papilledema; or Cushing's triad\].
- groups
- description
- Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 6 cycles. Thereafter, participants with PR or better response persisting for \>= 2 months on QW received 76 mg every Q2W and/or 116 mg or 152 mg Q4W from C7 and onwards. One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
- id
- OG000
- title
- Part 1
- description
- Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 1 received 116 mg Q2W for C2 to C6 and 116 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
- id
- OG001
- title
- Part 2A: Dose Level 1
- description
- Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, in dose level 2 participants received 152 mg Q2W for C2 to C6 and 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>= 2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
- id
- OG002
- title
- Part 2A: Dose Level 2
- description
- Participants received elranatamab 4 mg on C1D1 and 20 mg on C1D4 and then 76 mg QW for 1 cycle. Thereafter, participants were received 116 or 152 mg Q2W for C2 to 6 and 116 mg or 152 mg Q4W from C7 and onwards (participants with PR or better response persisting for \>=2 months on Q2W). One cycle =28 days. Treatment continued until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
- id
- OG003
- title
- Part 2B
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Safety analysis set included all enrolled participants who received at least 1 dose of study intervention.
- reporting Status
- POSTED
- time Frame
- Day 1 of dosing up to 90 days post last dose (maximum treatment duration 25 cycles, follow up to 790 days)
- title
- Number of Participants With Adverse Events of Special Interest (AESI)- CRS and Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS) [All Causalities and Treatment Related]: Parts 1 and 2
- type
- SECONDARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice