TriangleNCT04892446 · OUTCOME
Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0
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 1.3 years plus 70 days
What was measured
Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and included the date of last dose of study drug plus 70 days for participants who permanently discontinued study drug, or the day before initiation of new anticancer therapy including stem cell transplant (SCT) (whichever was earlier). If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Percentages are rounded off.
Analysis population: Participants in the Safety Analysis Set were analyzed. As all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms.
Groups in this outcome
Magrolimab+Daratumumab
Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received daratumumab 1800 mg SC or 16 mg/kg IV on Days 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycle 2; and Days 1, 15 (every 2 weeks) until Cycle 6 (total of 8 doses) followed by Day 1 (every 4 weeks) for subsequent cycles. (Cycle 1=35 days, All other Cycles=28 days).
Magrolimab+Pomalidomide+Dexamethasone
Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received pomalidomide orally 4 mg on Days 1 to 21 (daily) of Cycle 1 and onward and dexamethasone orally 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycle 2 and onward. (Cycle 1=35 days, All other Cycles=28 days).
Magrolimab+Carfilzomib+Dexamethasone
Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received carfilzomib IV 20 mg/m\^2 on Days 8, 15, 22 of Cycle 1; Days 1, 8, 15 of Cycle 2 and onward (if the carfilzomib starting dose of 20 mg/m\^2 was tolerated after Cycle 1, Day 8, the dose was escalated to 70 mg/m\^2 on Cycle 1, Day 15 and thereafter) and dexamethasone orally or IV 40 mg on Days 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days).
| Group | Source count |
|---|---|
| Magrolimab+Daratumumab | 14 |
| Magrolimab+Pomalidomide+Dexamethasone | 10 |
| Magrolimab+Carfilzomib+Dexamethasone | 11 |
Reported measurements
Hematology: Any Grade 1 or Higher
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Magrolimab+Daratumumab | 92.9 | Not reported | Not reported | Not reported | Not reported |
| Magrolimab+Pomalidomide+Dexamethasone | 100 | Not reported | Not reported | Not reported | Not reported |
| Magrolimab+Carfilzomib+Dexamethasone | 100 | Not reported | Not reported | Not reported | Not reported |
Chemistry: Any Grade 1 or Higher
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Magrolimab+Daratumumab | 92.9 | Not reported | Not reported | Not reported | Not reported |
| Magrolimab+Pomalidomide+Dexamethasone | 100 | Not reported | Not reported | Not reported | Not reported |
| Magrolimab+Carfilzomib+Dexamethasone | 100 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 92.9
- group Id
- OG001
- value
- 100
- group Id
- OG002
- value
- 100
- title
- Hematology: Any Grade 1 or Higher
- categories
- measurements
- group Id
- OG000
- value
- 92.9
- group Id
- OG001
- value
- 100
- group Id
- OG002
- value
- 100
- title
- Chemistry: Any Grade 1 or Higher
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 11
- units
- Participants
- description
- Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline time point, up to and included the date of last dose of study drug plus 70 days for participants who permanently discontinued study drug, or the day before initiation of new anticancer therapy including stem cell transplant (SCT) (whichever was earlier). If the relevant baseline laboratory value was missing, any abnormality of at least Grade 1 observed within the time frame specified above was considered treatment emergent. Percentages are rounded off.
- groups
- description
- Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received daratumumab 1800 mg SC or 16 mg/kg IV on Days 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycle 2; and Days 1, 15 (every 2 weeks) until Cycle 6 (total of 8 doses) followed by Day 1 (every 4 weeks) for subsequent cycles. (Cycle 1=35 days, All other Cycles=28 days).
- id
- OG000
- title
- Magrolimab+Daratumumab
- description
- Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received pomalidomide orally 4 mg on Days 1 to 21 (daily) of Cycle 1 and onward and dexamethasone orally 40 mg on Days 1, 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycle 2 and onward. (Cycle 1=35 days, All other Cycles=28 days).
- id
- OG001
- title
- Magrolimab+Pomalidomide+Dexamethasone
- description
- Participants in Safety Run-in and Dose-expansion period with relapsed/refractory multiple myeloma who have had 3 or more prior therapies including an IMiD and a PI received magrolimab IV 1 mg/kg on Day 1 and 30 mg/kg on Days 8, 15, 22, 29 of Cycle 1; 30 mg/kg every week on Days 1, 8, 15, 22 of Cycle 2; 30 mg/kg on Days 1, 15 from Cycle 3 onwards. Participants also received carfilzomib IV 20 mg/m\^2 on Days 8, 15, 22 of Cycle 1; Days 1, 8, 15 of Cycle 2 and onward (if the carfilzomib starting dose of 20 mg/m\^2 was tolerated after Cycle 1, Day 8, the dose was escalated to 70 mg/m\^2 on Cycle 1, Day 15 and thereafter) and dexamethasone orally or IV 40 mg on Days 8, 15, 22, 29 of Cycle 1; Days 1, 8, 15, 22 of Cycles 2 to 9 and then Days 1, 8, 15 from Cycle 10 and onward. (Cycle 1=35 days, All other Cycles=28 days).
- id
- OG002
- title
- Magrolimab+Carfilzomib+Dexamethasone
- param Type
- NUMBER
- population Description
- Participants in the Safety Analysis Set were analyzed. As all participants were dosed with same dose of magrolimab, per prespecified analysis, data for Safety Run-in and corresponding Dose-expansion cohorts were combined for all 3 arms.
- reporting Status
- POSTED
- time Frame
- Up to 1.3 years plus 70 days
- title
- Percentage of Participants Experiencing Treatment-emergent Laboratory Abnormalities According to the NCI CTCAE Version 5.0
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice