Skip to content
← Full study record

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

GroupSource count
Magrolimab+Daratumumab10
Magrolimab+Pomalidomide+Dexamethasone10
Magrolimab+Carfilzomib+Dexamethasone10

Reported measurements

Predose: Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Magrolimab+Daratumumab10
Magrolimab+Pomalidomide+Dexamethasone10
Magrolimab+Carfilzomib+Dexamethasone10
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Magrolimab+DaratumumabNANANot reportedNot reportedMean and standard deviation were not calculable as the values were below the limit of quantitation
Magrolimab+Pomalidomide+DexamethasoneNANANot reportedNot reportedMean and standard deviation were not calculable as the values were below the limit of quantitation
Magrolimab+Carfilzomib+DexamethasoneNANANot reportedNot reportedMean and standard deviation were not calculable as the values were below the limit of quantitation
Predose: Cycle 1 Day 22

Analysis denominator · Participants

GroupSource count
Magrolimab+Daratumumab8
Magrolimab+Pomalidomide+Dexamethasone8
Magrolimab+Carfilzomib+Dexamethasone7
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Magrolimab+Daratumumab435000245000Not reportedNot reportedNot reported
Magrolimab+Pomalidomide+Dexamethasone303000182000Not reportedNot reportedNot reported
Magrolimab+Carfilzomib+Dexamethasone421000115000Not reportedNot reportedNot reported
Predose: Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Magrolimab+Daratumumab7
Magrolimab+Pomalidomide+Dexamethasone5
Magrolimab+Carfilzomib+Dexamethasone8
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Magrolimab+Daratumumab621000233000Not reportedNot reportedNot reported
Magrolimab+Pomalidomide+Dexamethasone713000293000Not reportedNot reportedNot reported
Magrolimab+Carfilzomib+Dexamethasone675000274000Not reportedNot reportedNot reported
Predose: Cycle 3 Day 1

Analysis denominator · Participants

GroupSource count
Magrolimab+Daratumumab4
Magrolimab+Pomalidomide+Dexamethasone6
Magrolimab+Carfilzomib+Dexamethasone8
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Magrolimab+Daratumumab853000399000Not reportedNot reportedNot reported
Magrolimab+Pomalidomide+Dexamethasone739000365000Not reportedNot reportedNot reported
Magrolimab+Carfilzomib+Dexamethasone847000238000Not reportedNot reportedNot reported
Predose: Cycle 4 Day 1

Analysis denominator · Participants

GroupSource count
Magrolimab+Daratumumab2
Magrolimab+Pomalidomide+Dexamethasone1
Magrolimab+Carfilzomib+Dexamethasone2
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Magrolimab+Daratumumab69400082700Not reportedNot reportedNot reported
Magrolimab+Pomalidomide+Dexamethasone5540NANot reportedNot reportedStandard deviation was not calculable due to less than 3 participants available for analysis.
Magrolimab+Carfilzomib+Dexamethasone459000161000Not reportedNot reportedNot reported
Predose: Cycle 5 Day 1

Analysis denominator · Participants

GroupSource count
Magrolimab+Daratumumab3
Magrolimab+Pomalidomide+Dexamethasone5
Magrolimab+Carfilzomib+Dexamethasone5
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Magrolimab+Daratumumab517000186000Not reportedNot reportedNot reported
Magrolimab+Pomalidomide+Dexamethasone373000142000Not reportedNot reportedNot reported
Magrolimab+Carfilzomib+Dexamethasone44800090700Not reportedNot reportedNot reported
Predose: Cycle 7 Day 1

Analysis denominator · Participants

GroupSource count
Magrolimab+Daratumumab1
Magrolimab+Pomalidomide+Dexamethasone3
Magrolimab+Carfilzomib+Dexamethasone4
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Magrolimab+Daratumumab332000NANot reportedNot reportedStandard deviation was not calculable due to less than 3 participants available for analysis.
Magrolimab+Pomalidomide+Dexamethasone307000153000Not reportedNot reportedNot reported
Magrolimab+Carfilzomib+Dexamethasone376000140000Not reportedNot reportedNot reported
Predose: Cycle 10 Day 1

Analysis denominator · Participants

GroupSource count
Magrolimab+Daratumumab1
Magrolimab+Pomalidomide+Dexamethasone0
Magrolimab+Carfilzomib+Dexamethasone2
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Magrolimab+Daratumumab336000NANot reportedNot reportedStandard deviation was not calculable due to less than 3 participants available for analysis.
Magrolimab+Carfilzomib+Dexamethasone361000345000Not reportedNot reportedNot reported
Predose: Cycle 13 Day 1

Analysis denominator · Participants

GroupSource count
Magrolimab+Daratumumab1
Magrolimab+Pomalidomide+Dexamethasone0
Magrolimab+Carfilzomib+Dexamethasone1
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Magrolimab+Daratumumab295000NANot reportedNot reportedStandard deviation was not calculable due to less than 3 participants available for analysis.
Magrolimab+Carfilzomib+Dexamethasone624000NANot reportedNot reportedStandard 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

GroupSource count
Magrolimab+Daratumumab9
Magrolimab+Pomalidomide+Dexamethasone6
Magrolimab+Carfilzomib+Dexamethasone2
Values in ng/mL · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Magrolimab+Daratumumab445000337000Not reportedNot reportedNot reported
Magrolimab+Pomalidomide+Dexamethasone179000131000Not reportedNot reportedNot reported
Magrolimab+Carfilzomib+Dexamethasone8600034000Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Mean and standard deviation were not calculable as the values were below the limit of quantitation
        group Id
        OG000
        spread
        NA
        value
        NA
      2. comment
        Mean and standard deviation were not calculable as the values were below the limit of quantitation
        group Id
        OG001
        spread
        NA
        value
        NA
      3. 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
    1. counts
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        10
      units
      Participants
    title
    Predose: Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        245000
        value
        435000
      2. group Id
        OG001
        spread
        182000
        value
        303000
      3. group Id
        OG002
        spread
        115000
        value
        421000
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        7
      units
      Participants
    title
    Predose: Cycle 1 Day 22
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        233000
        value
        621000
      2. group Id
        OG001
        spread
        293000
        value
        713000
      3. group Id
        OG002
        spread
        274000
        value
        675000
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    Predose: Cycle 2 Day 1
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        399000
        value
        853000
      2. group Id
        OG001
        spread
        365000
        value
        739000
      3. group Id
        OG002
        spread
        238000
        value
        847000
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    Predose: Cycle 3 Day 1
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        82700
        value
        694000
      2. comment
        Standard deviation was not calculable due to less than 3 participants available for analysis.
        group Id
        OG001
        spread
        NA
        value
        5540
      3. group Id
        OG002
        spread
        161000
        value
        459000
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Predose: Cycle 4 Day 1
  6. categories
    1. measurements
      1. group Id
        OG000
        spread
        186000
        value
        517000
      2. group Id
        OG001
        spread
        142000
        value
        373000
      3. group Id
        OG002
        spread
        90700
        value
        448000
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        5
      3. group Id
        OG002
        value
        5
      units
      Participants
    title
    Predose: Cycle 5 Day 1
  7. categories
    1. measurements
      1. comment
        Standard deviation was not calculable due to less than 3 participants available for analysis.
        group Id
        OG000
        spread
        NA
        value
        332000
      2. group Id
        OG001
        spread
        153000
        value
        307000
      3. group Id
        OG002
        spread
        140000
        value
        376000
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
      units
      Participants
    title
    Predose: Cycle 7 Day 1
  8. categories
    1. measurements
      1. comment
        Standard deviation was not calculable due to less than 3 participants available for analysis.
        group Id
        OG000
        spread
        NA
        value
        336000
      2. group Id
        OG002
        spread
        345000
        value
        361000
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Predose: Cycle 10 Day 1
  9. categories
    1. measurements
      1. comment
        Standard deviation was not calculable due to less than 3 participants available for analysis.
        group Id
        OG000
        spread
        NA
        value
        295000
      2. comment
        Standard deviation was not calculable due to less than 3 participants available for analysis.
        group Id
        OG002
        spread
        NA
        value
        624000
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    Predose: Cycle 13 Day 1
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        337000
        value
        445000
      2. group Id
        OG001
        spread
        131000
        value
        179000
      3. group Id
        OG002
        spread
        34000
        value
        86000
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        2
      units
      Participants
    title
    Anytime: Last sample collection day: Up to Day 358
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    3. 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
  1. 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
  2. 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
  3. 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