TriangleNCT05014412 · OUTCOME
Number of Participants With Dose Limiting Toxicities (DLTs): Part 2A
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
- Part 2A: 28 days starting from the first 116 or 152 mg dose
What was measured
Hematological: grade 4 neutropenia lasting \>5 days; febrile neutropenia; grade \>=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with grade \>=2 bleeding. Non-hematological: grade \>=4 adverse events (AEs); grade 3 CRS (except CRS events: not been maximally treated or improved to grade \<=1 within 48 hours); grade 3 AEs (except: AEs attributed to a CRS event; grade 3 nausea, vomiting and diarrhea that improve to grade \<= 2 within 72 hours after maximal medical management has been initiated, grade 3 fatigue lasting \<1 week; grade 3 AEs that recover to baseline or grade 1 within 5 days); confirmed drug-induced liver injury meeting Hy's law criteria; grade 3-4 laboratory abnormalities; other clinically important or persistent AEs; Grade 3 injection site reaction. CTCAE version 5.0: Grade 1: Mild AE, Grade 2: Moderate, Grade 3: severe, and grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE.
Analysis population: All enrolled participants in Part 2A who received the planned 2 doses of 116 mg or 152 mg of study intervention during the DLT observation period or who received at least 1 dose of 116 mg or 152 mg of study intervention and experience DLT(s) during the DLT observation period. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 and Part 2B of the study.
Groups in this outcome
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.
| Group | Source count |
|---|---|
| Part 2A: Dose Level 1 | 7 |
| Part 2A: Dose Level 2 | 7 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 2A: Dose Level 1 | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 2A: Dose Level 2 | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 7
- units
- Participants
- description
- Hematological: grade 4 neutropenia lasting \>5 days; febrile neutropenia; grade \>=3 neutropenia with infection; grade 4 thrombocytopenia; grade 3 thrombocytopenia with grade \>=2 bleeding. Non-hematological: grade \>=4 adverse events (AEs); grade 3 CRS (except CRS events: not been maximally treated or improved to grade \<=1 within 48 hours); grade 3 AEs (except: AEs attributed to a CRS event; grade 3 nausea, vomiting and diarrhea that improve to grade \<= 2 within 72 hours after maximal medical management has been initiated, grade 3 fatigue lasting \<1 week; grade 3 AEs that recover to baseline or grade 1 within 5 days); confirmed drug-induced liver injury meeting Hy's law criteria; grade 3-4 laboratory abnormalities; other clinically important or persistent AEs; Grade 3 injection site reaction. CTCAE version 5.0: Grade 1: Mild AE, Grade 2: Moderate, Grade 3: severe, and grade 4: life-threatening consequences; urgent intervention indicated. Grade 5: death related to AE.
- groups
- 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
- OG000
- 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
- OG001
- title
- Part 2A: Dose Level 2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All enrolled participants in Part 2A who received the planned 2 doses of 116 mg or 152 mg of study intervention during the DLT observation period or who received at least 1 dose of 116 mg or 152 mg of study intervention and experience DLT(s) during the DLT observation period. Here "Overall Number of Participants Analyzed" signifies the number of participants evaluable for this outcome measure. This outcome measure was not planned to be analyzed in Part 1 and Part 2B of the study.
- reporting Status
- POSTED
- time Frame
- Part 2A: 28 days starting from the first 116 or 152 mg dose
- title
- Number of Participants With Dose Limiting Toxicities (DLTs): Part 2A
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice