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NCT07217184 · OUTCOME

DE Phase: Plasma Concentration of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)

Sub-study of Belantamab Mafodotin (GSK2857916) in Combination With Isatuximab in Participants With RRMM · Source last updated 2026-06-25

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEAN
Unit
Picogram / millilitre (pg/mL)
Interval / dispersion
Standard Deviation
Time frame
Predose, end of infusion (EOI), and 2-hour and 24-hour postdose on Cycle 1 Day 1; predose on Cycle 1 Days 8, 15 and 22, anytime samples on C1D8 and C1D22 ; predose and EOI on Day 1 of Cycles 2, 4, 6, 9 and 12; and end of treatment (~194 weeks).

What was measured

Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).

Analysis population: PK population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. The "0" participants analyzed represents that data was not collected for analysis at that particular time point for the respective Arms/Groups.

Groups in this outcome

1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab

Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.

1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.

1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab

Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab10
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10

Reported measurements

CYCLE 1 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab9
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab9
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab137.78413.333Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab36.78110.333Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.000.000Not reportedNot reportedNot reported
CYCLE 1 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab9
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab9
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab602.56589.458Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab433.89564.095Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab772.90758.482Not reportedNot reportedNot reported
CYCLE 1 DAY 1, 2 HOURS

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab9
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab10
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab660.78592.060Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab381.34497.727Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab689.70541.778Not reportedNot reportedNot reported
CYCLE 1 DAY 1, 24 HOURS

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab9
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab9
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab796.67277.976Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab809.50550.083Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab1075.561111.764Not reportedNot reportedNot reported
CYCLE 1 DAY 8, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab6
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab9
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab137.6259.834Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab124.5352.716Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab198.8088.967Not reportedNot reportedNot reported
CYCLE 1 DAY 8, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab1
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab125.00NANot reportedNot reportedSD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
CYCLE 1 DAY 15, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab7
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab8
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0.000.000Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.000.000Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab13.9825.948Not reportedNot reportedNot reported
CYCLE 1 DAY 22, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab6
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab8
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0.000.000Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.000.000Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.000.000Not reportedNot reportedNot reported
CYCLE 1 DAY 22, ANYTIME SAMPLE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab1
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.00NANot reportedNot reportedSD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
CYCLE 2 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab8
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab7
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0.000.000Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.000.000Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.000.000Not reportedNot reportedNot reported
CYCLE 2 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab8
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab7
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab480.13494.302Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab372.25239.605Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab319.86153.035Not reportedNot reportedNot reported
CYCLE 4 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab3
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab2
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab6
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0.000.000Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.000.000Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.000.000Not reportedNot reportedNot reported
CYCLE 4 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab3
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab2
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab6
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab1128.671622.007Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab548.00550.129Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab393.83408.512Not reportedNot reportedNot reported
CYCLE 6 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab3
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab1
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab4
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0.000.000Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.00NANot reportedNot reportedSD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.000.000Not reportedNot reportedNot reported
CYCLE 6 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab3
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab1
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab4
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab677.67773.029Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab194.00NANot reportedNot reportedSD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab231.00100.416Not reportedNot reportedNot reported
CYCLE 9 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab2
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab2
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0.000.000Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.000.000Not reportedNot reportedNot reported
CYCLE 9 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab2
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab2
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab242.95229.173Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab277.00190.919Not reportedNot reportedNot reported
CYCLE 12 DAY 1, PRE-DOSE

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab1
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0.00NANot reportedNot reportedSD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
CYCLE 12 DAY 1, END OF INFUSION

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab0
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab0
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab1
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab258.00NANot reportedNot reportedSD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
END OF TREATMENT (~194 weeks)

Analysis denominator · Participants

GroupSource count
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab8
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab8
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab6
Values in Picogram / millilitre (pg/mL) · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab19.7937.174Not reportedNot reportedNot reported
1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab43.50123.037Not reportedNot reportedNot reported
1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab19.6748.173Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        413.333
        value
        137.78
      2. group Id
        OG001
        spread
        110.333
        value
        36.78
      3. group Id
        OG002
        spread
        0.000
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        10
      units
      Participants
    title
    CYCLE 1 DAY 1, PRE-DOSE
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        589.458
        value
        602.56
      2. group Id
        OG001
        spread
        564.095
        value
        433.89
      3. group Id
        OG002
        spread
        758.482
        value
        772.90
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        9
      3. group Id
        OG002
        value
        10
      units
      Participants
    title
    CYCLE 1 DAY 1, END OF INFUSION
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        592.060
        value
        660.78
      2. group Id
        OG001
        spread
        497.727
        value
        381.34
      3. group Id
        OG002
        spread
        541.778
        value
        689.70
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        10
      3. group Id
        OG002
        value
        10
      units
      Participants
    title
    CYCLE 1 DAY 1, 2 HOURS
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        277.976
        value
        796.67
      2. group Id
        OG001
        spread
        550.083
        value
        809.50
      3. group Id
        OG002
        spread
        1111.764
        value
        1075.56
    denoms
    1. counts
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        9
      units
      Participants
    title
    CYCLE 1 DAY 1, 24 HOURS
  5. categories
    1. measurements
      1. group Id
        OG000
        spread
        59.834
        value
        137.62
      2. group Id
        OG001
        spread
        52.716
        value
        124.53
      3. group Id
        OG002
        spread
        88.967
        value
        198.80
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        9
      units
      Participants
    title
    CYCLE 1 DAY 8, PRE-DOSE
  6. categories
    1. measurements
      1. comment
        SD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
        group Id
        OG000
        spread
        NA
        value
        125.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      units
      Participants
    title
    CYCLE 1 DAY 8, ANYTIME SAMPLE
  7. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.000
        value
        0.00
      2. group Id
        OG001
        spread
        0.000
        value
        0.00
      3. group Id
        OG002
        spread
        25.948
        value
        13.98
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    CYCLE 1 DAY 15, PRE-DOSE
  8. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.000
        value
        0.00
      2. group Id
        OG001
        spread
        0.000
        value
        0.00
      3. group Id
        OG002
        spread
        0.000
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        8
      units
      Participants
    title
    CYCLE 1 DAY 22, PRE-DOSE
  9. categories
    1. measurements
      1. comment
        SD is not applicable as only a single participant was analyzed. Mean value presented here is the actual concentration for this single participant.
        group Id
        OG002
        spread
        NA
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      units
      Participants
    title
    CYCLE 1 DAY 22, ANYTIME SAMPLE
  10. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.000
        value
        0.00
      2. group Id
        OG001
        spread
        0.000
        value
        0.00
      3. group Id
        OG002
        spread
        0.000
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        7
      units
      Participants
    title
    CYCLE 2 DAY 1, PRE-DOSE
  11. categories
    1. measurements
      1. group Id
        OG000
        spread
        494.302
        value
        480.13
      2. group Id
        OG001
        spread
        239.605
        value
        372.25
      3. group Id
        OG002
        spread
        153.035
        value
        319.86
    denoms
    1. counts
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        8
      3. group Id
        OG002
        value
        7
      units
      Participants
    title
    CYCLE 2 DAY 1, END OF INFUSION
  12. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.000
        value
        0.00
      2. group Id
        OG001
        spread
        0.000
        value
        0.00
      3. group Id
        OG002
        spread
        0.000
        value
        0.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      units
      Participants
    title
    CYCLE 4 DAY 1, PRE-DOSE
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    2. group Id
      OG001
      value
      10
    3. group Id
      OG002
      value
      10
    units
    Participants
description
Blood samples were collected for PK analysis of belantamab mafodotin cys- monomethyl auristatin-F (cys-mcMMAF).
dispersion Type
Standard Deviation
groups
  1. description
    Participants with Relapsed/Refractory Multiple Myeloma (RRMM) received 1.9 milligram (mg)/kilogram (kg) of belantamab mafodotin intravenous (IV) infusion once every 4 weeks (Q4W) infused over 30- 60 minutes on day 1 of each 28-day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin end of infusion (EOI), administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W), and thereafter on day 1, 8, 15 and 22 of each 28-day cycle.
    id
    OG000
    title
    1.9 Milligram (mg)/Kilogram (kg) Belantamab Mafodotin (Q4W) + Isatuximab
  2. description
    Participants with RRMM received 1.4 mg/kg of belantamab mafodotin IV infusion, once every 8 weeks (Q8W) infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG001
    title
    1.4 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
  3. description
    Participants with RRMM received 1.9 mg/kg of belantamab mafodotin IV infusion, Q8W infused over 30- 60 minutes on day 1 of each 56 day cycle in combination with 10 mg/kg isatuximab, given 1 hour after belantamab mafodotin EOI administered as an IV infusion once weekly (Q1W) for 5 doses, then every 2 weeks (Q2W) and thereafter on days 1, 8, 15, and 22 of each 28-day cycle.
    id
    OG002
    title
    1.9 mg/kg Belantamab Mafodotin (Q8W) + Isatuximab
param Type
MEAN
population Description
PK population. Only those participants who were measured and analyzed (i.e., contributed data reported in the table) were included in the Overall Number of Participants Analyzed field. 'Number Analyzed' signifies participants evaluable for the specified timepoints. The "0" participants analyzed represents that data was not collected for analysis at that particular time point for the respective Arms/Groups.
reporting Status
POSTED
time Frame
Predose, end of infusion (EOI), and 2-hour and 24-hour postdose on Cycle 1 Day 1; predose on Cycle 1 Days 8, 15 and 22, anytime samples on C1D8 and C1D22 ; predose and EOI on Day 1 of Cycles 2, 4, 6, 9 and 12; and end of treatment (~194 weeks).
title
DE Phase: Plasma Concentration of Belantamab Mafodotin Cys- Monomethyl Auristatin-F (Cys-mcMMAF)
type
SECONDARY
unit Of Measure
Picogram / millilitre (pg/mL)

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