NCT04892446 · OUTCOME
Serum Concentration of Magrolimab
Study of Magrolimab Combinations in Patients With Relapsed/Refractory Multiple Myeloma · Source last updated 2025-05-02
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/mL
- Interval / dispersion
- Standard Deviation
- Time frame
- Arm 1, 2, 3: Predose: Days 1 and 22 of Cycle 1, Day 1 of Cycles 2, 3, 4, 5, 7, and on last sample collection day (anytime; up to Day 358); Arm 1 and 3: Predose: Day 1 of Cycles 10 and 13
What was measured
Arm 1: Magrolimab+Daratumumab; Arm 2: Magrolimab+Pomalidomide+Dexamethasone; Arm 3: Magrolimab+Carfilzomib+Dexamethasone.
Analysis population: The Pharmacokinetic Analysis Set included all participants who received ≥ 1 dose of magrolimab and had ≥ 1 measurable posttreatment serum concentration of magrolimab. Participants with available data 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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 10 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 10 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 10 |
|---|
Reported measurements
Predose: Cycle 1 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 10 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 10 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 10 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Magrolimab+Daratumumab | NA | NA | Not reported | Not reported | Mean and standard deviation were not calculable as the values were below the limit of quantitation |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | NA | NA | Not reported | Not reported | Mean and standard deviation were not calculable as the values were below the limit of quantitation |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | NA | NA | Not reported | Not reported | Mean and standard deviation were not calculable as the values were below the limit of quantitation |
|---|
Predose: Cycle 1 Day 22
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 8 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 8 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 7 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Magrolimab+Daratumumab | 435000 | 245000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 303000 | 182000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 421000 | 115000 | Not reported | Not reported | Not reported |
|---|
Predose: Cycle 2 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 7 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 5 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 8 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Magrolimab+Daratumumab | 621000 | 233000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 713000 | 293000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 675000 | 274000 | Not reported | Not reported | Not reported |
|---|
Predose: Cycle 3 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 4 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 6 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 8 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Magrolimab+Daratumumab | 853000 | 399000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 739000 | 365000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 847000 | 238000 | Not reported | Not reported | Not reported |
|---|
Predose: Cycle 4 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 2 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 1 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 2 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Magrolimab+Daratumumab | 694000 | 82700 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 5540 | NA | Not reported | Not reported | Standard deviation was not calculable due to less than 3 participants available for analysis. |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 459000 | 161000 | Not reported | Not reported | Not reported |
|---|
Predose: Cycle 5 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 3 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 5 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 5 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Magrolimab+Daratumumab | 517000 | 186000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 373000 | 142000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 448000 | 90700 | Not reported | Not reported | Not reported |
|---|
Predose: Cycle 7 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 1 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 3 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 4 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Magrolimab+Daratumumab | 332000 | NA | Not reported | Not reported | Standard deviation was not calculable due to less than 3 participants available for analysis. |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 307000 | 153000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 376000 | 140000 | Not reported | Not reported | Not reported |
|---|
Predose: Cycle 10 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 1 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 0 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 2 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Magrolimab+Daratumumab | 336000 | NA | Not reported | Not reported | Standard deviation was not calculable due to less than 3 participants available for analysis. |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 361000 | 345000 | Not reported | Not reported | Not reported |
|---|
Predose: Cycle 13 Day 1
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 1 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 0 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 1 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Magrolimab+Daratumumab | 295000 | NA | Not reported | Not reported | Standard deviation was not calculable due to less than 3 participants available for analysis. |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 624000 | NA | Not reported | Not reported | Standard deviation was not calculable due to less than 3 participants available for analysis. |
|---|
Anytime: Last sample collection day: Up to Day 358
Analysis denominator · Participants
| Group | Source count |
|---|
| Magrolimab+Daratumumab | 9 |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 6 |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 2 |
|---|
Values in ng/mL · Interval/dispersion: Standard Deviation| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Magrolimab+Daratumumab | 445000 | 337000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Pomalidomide+Dexamethasone | 179000 | 131000 | Not reported | Not reported | Not reported |
|---|
| Magrolimab+Carfilzomib+Dexamethasone | 86000 | 34000 | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- comment
- Mean and standard deviation were not calculable as the values were below the limit of quantitation
- group Id
- OG000
- spread
- NA
- value
- NA
- comment
- Mean and standard deviation were not calculable as the values were below the limit of quantitation
- group Id
- OG001
- spread
- NA
- value
- NA
- comment
- Mean and standard deviation were not calculable as the values were below the limit of quantitation
- group Id
- OG002
- spread
- NA
- value
- NA
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 10
- units
- Participants
- title
- Predose: Cycle 1 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 245000
- value
- 435000
- group Id
- OG001
- spread
- 182000
- value
- 303000
- group Id
- OG002
- spread
- 115000
- value
- 421000
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 8
- group Id
- OG002
- value
- 7
- units
- Participants
- title
- Predose: Cycle 1 Day 22
- categories
- measurements
- group Id
- OG000
- spread
- 233000
- value
- 621000
- group Id
- OG001
- spread
- 293000
- value
- 713000
- group Id
- OG002
- spread
- 274000
- value
- 675000
- denoms
- counts
- group Id
- OG000
- value
- 7
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 8
- units
- Participants
- title
- Predose: Cycle 2 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 399000
- value
- 853000
- group Id
- OG001
- spread
- 365000
- value
- 739000
- group Id
- OG002
- spread
- 238000
- value
- 847000
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 8
- units
- Participants
- title
- Predose: Cycle 3 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 82700
- value
- 694000
- comment
- Standard deviation was not calculable due to less than 3 participants available for analysis.
- group Id
- OG001
- spread
- NA
- value
- 5540
- group Id
- OG002
- spread
- 161000
- value
- 459000
- denoms
- counts
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Predose: Cycle 4 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 186000
- value
- 517000
- group Id
- OG001
- spread
- 142000
- value
- 373000
- group Id
- OG002
- spread
- 90700
- value
- 448000
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 5
- units
- Participants
- title
- Predose: Cycle 5 Day 1
- categories
- measurements
- comment
- Standard deviation was not calculable due to less than 3 participants available for analysis.
- group Id
- OG000
- spread
- NA
- value
- 332000
- group Id
- OG001
- spread
- 153000
- value
- 307000
- group Id
- OG002
- spread
- 140000
- value
- 376000
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 4
- units
- Participants
- title
- Predose: Cycle 7 Day 1
- categories
- measurements
- comment
- Standard deviation was not calculable due to less than 3 participants available for analysis.
- group Id
- OG000
- spread
- NA
- value
- 336000
- group Id
- OG002
- spread
- 345000
- value
- 361000
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Predose: Cycle 10 Day 1
- categories
- measurements
- comment
- Standard deviation was not calculable due to less than 3 participants available for analysis.
- group Id
- OG000
- spread
- NA
- value
- 295000
- comment
- Standard deviation was not calculable due to less than 3 participants available for analysis.
- group Id
- OG002
- spread
- NA
- value
- 624000
- denoms
- counts
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- units
- Participants
- title
- Predose: Cycle 13 Day 1
- categories
- measurements
- group Id
- OG000
- spread
- 337000
- value
- 445000
- group Id
- OG001
- spread
- 131000
- value
- 179000
- group Id
- OG002
- spread
- 34000
- value
- 86000
- denoms
- counts
- group Id
- OG000
- value
- 9
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 2
- units
- Participants
- title
- Anytime: Last sample collection day: Up to Day 358
- denoms
- counts
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 10
- group Id
- OG002
- value
- 10
- units
- Participants
- description
- Arm 1: Magrolimab+Daratumumab; Arm 2: Magrolimab+Pomalidomide+Dexamethasone; Arm 3: Magrolimab+Carfilzomib+Dexamethasone.
- dispersion Type
- Standard Deviation
- 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
- MEAN
- population Description
- The Pharmacokinetic Analysis Set included all participants who received ≥ 1 dose of magrolimab and had ≥ 1 measurable posttreatment serum concentration of magrolimab. Participants with available data 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
- Arm 1, 2, 3: Predose: Days 1 and 22 of Cycle 1, Day 1 of Cycles 2, 3, 4, 5, 7, and on last sample collection day (anytime; up to Day 358); Arm 1 and 3: Predose: Day 1 of Cycles 10 and 13
- title
- Serum Concentration of Magrolimab
- type
- SECONDARY
- unit Of Measure
- ng/mL
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice