Skip to content
← Full study record

NCT03215030 · OUTCOME

Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa

A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma · Source last updated 2026-01-29

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

Measure
MEDIAN
Unit
hours
Interval / dispersion
Full Range
Time frame
Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)

What was measured

As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.

Analysis population: The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.

Groups in this outcome

Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg

Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg

Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg

Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg

Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg

Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg

Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg

Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg

Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg

Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.

Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg

Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.

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

Analysis denominator · Participants

GroupSource count
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg3
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg6
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg3
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg3
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg4
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg4
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg4
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg2
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg6
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg3

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg3
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg6
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg3
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg3
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg4
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg4
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg4
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg2
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg6
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg3
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg4.03Not reported3.974.15Not reported
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg3.99Not reported1.954.25Not reported
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg4.40Not reported3.926.10Not reported
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg4.27Not reported4.006.28Not reported
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg4.75Not reported3.975.60Not reported
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg4.03Not reported4.004.10Not reported
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg4.78Not reported3.876.05Not reported
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg3.07Not reported2.074.07Not reported
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg4.94Not reported4.006.02Not reported
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg4.03Not reported3.777.65Not reported
Cycle 1 Day 15

Analysis denominator · Participants

GroupSource count
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg3
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg4
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg3
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg2
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg3
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg3
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg0
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg0
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg0
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg0
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg3.93Not reported2.024.05Not reported
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg4.02Not reported3.934.20Not reported
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg4.25Not reported4.084.35Not reported
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg5.87Not reported5.785.95Not reported
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg4.28Not reported4.156.17Not reported
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg4.00Not reported4.004.10Not reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg2
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg1
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg2
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg0
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg0
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg1
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg3
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg2
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg5
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg2
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg2.97Not reported1.973.98Not reported
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg4.23Not reported4.234.23Not reported
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg3.98Not reported3.904.05Not reported
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg4.45Not reported4.454.45Not reported
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg4.00Not reported3.905.92Not reported
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg3.21Not reported2.234.18Not reported
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg4.13Not reported3.905.95Not reported
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg5.52Not reported3.987.05Not reported
Cycle 2 Day 15

Analysis denominator · Participants

GroupSource count
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg0
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg0
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg0
Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg0
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg1
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg1
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg0
Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg0
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg0
Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg0
Values in hours · Interval/dispersion: Full Range
GroupValueSpreadLowerUpperComment
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg5.65Not reported5.655.65Not reported
Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg4.00Not reported4.004.00Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        3.97
        upper Limit
        4.15
        value
        4.03
      2. group Id
        OG001
        lower Limit
        1.95
        upper Limit
        4.25
        value
        3.99
      3. group Id
        OG002
        lower Limit
        3.92
        upper Limit
        6.10
        value
        4.40
      4. group Id
        OG003
        lower Limit
        4.00
        upper Limit
        6.28
        value
        4.27
      5. group Id
        OG004
        lower Limit
        3.97
        upper Limit
        5.60
        value
        4.75
      6. group Id
        OG005
        lower Limit
        4.00
        upper Limit
        4.10
        value
        4.03
      7. group Id
        OG006
        lower Limit
        3.87
        upper Limit
        6.05
        value
        4.78
      8. group Id
        OG007
        lower Limit
        2.07
        upper Limit
        4.07
        value
        3.07
      9. group Id
        OG008
        lower Limit
        4.00
        upper Limit
        6.02
        value
        4.94
      10. group Id
        OG009
        lower Limit
        3.77
        upper Limit
        7.65
        value
        4.03
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        6
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
      5. group Id
        OG004
        value
        4
      6. group Id
        OG005
        value
        4
      7. group Id
        OG006
        value
        4
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        6
      10. group Id
        OG009
        value
        3
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        2.02
        upper Limit
        4.05
        value
        3.93
      2. group Id
        OG001
        lower Limit
        3.93
        upper Limit
        4.20
        value
        4.02
      3. group Id
        OG002
        lower Limit
        4.08
        upper Limit
        4.35
        value
        4.25
      4. group Id
        OG003
        lower Limit
        5.78
        upper Limit
        5.95
        value
        5.87
      5. group Id
        OG004
        lower Limit
        4.15
        upper Limit
        6.17
        value
        4.28
      6. group Id
        OG005
        lower Limit
        4.00
        upper Limit
        4.10
        value
        4.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        2
      5. group Id
        OG004
        value
        3
      6. group Id
        OG005
        value
        3
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      units
      Participants
    title
    Cycle 1 Day 15
  3. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        1.97
        upper Limit
        3.98
        value
        2.97
      2. group Id
        OG001
        lower Limit
        4.23
        upper Limit
        4.23
        value
        4.23
      3. group Id
        OG002
        lower Limit
        3.90
        upper Limit
        4.05
        value
        3.98
      4. group Id
        OG005
        lower Limit
        4.45
        upper Limit
        4.45
        value
        4.45
      5. group Id
        OG006
        lower Limit
        3.90
        upper Limit
        5.92
        value
        4.00
      6. group Id
        OG007
        lower Limit
        2.23
        upper Limit
        4.18
        value
        3.21
      7. group Id
        OG008
        lower Limit
        3.90
        upper Limit
        5.95
        value
        4.13
      8. group Id
        OG009
        lower Limit
        3.98
        upper Limit
        7.05
        value
        5.52
    denoms
    1. counts
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        0
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        3
      8. group Id
        OG007
        value
        2
      9. group Id
        OG008
        value
        5
      10. group Id
        OG009
        value
        2
      units
      Participants
    title
    Cycle 2 Day 1
  4. categories
    1. measurements
      1. group Id
        OG004
        lower Limit
        5.65
        upper Limit
        5.65
        value
        5.65
      2. group Id
        OG005
        lower Limit
        4.00
        upper Limit
        4.00
        value
        4.00
    denoms
    1. counts
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        0
      4. group Id
        OG003
        value
        0
      5. group Id
        OG004
        value
        1
      6. group Id
        OG005
        value
        1
      7. group Id
        OG006
        value
        0
      8. group Id
        OG007
        value
        0
      9. group Id
        OG008
        value
        0
      10. group Id
        OG009
        value
        0
      units
      Participants
    title
    Cycle 2 Day 15
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      6
    3. group Id
      OG002
      value
      3
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      4
    6. group Id
      OG005
      value
      4
    7. group Id
      OG006
      value
      4
    8. group Id
      OG007
      value
      2
    9. group Id
      OG008
      value
      6
    10. group Id
      OG009
      value
      3
    units
    Participants
description
As per planned analysis, data for this outcome measure was collected and reported dose-wise for each treatment schedule.
dispersion Type
Full Range
groups
  1. description
    Participants received modakafusp alfa 0.01 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG000
    title
    Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.01 mg/kg
  2. description
    Participants received modakafusp alfa 0.1 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG001
    title
    Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.1 mg/kg
  3. description
    Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG002
    title
    Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.4 mg/kg
  4. description
    Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q1W on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG003
    title
    Part 1 (Dose Escalation) Schedule A: Modakafusp Alfa 0.75 mg/kg
  5. description
    Participants received modakafusp alfa 0.2 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG004
    title
    Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.2 mg/kg
  6. description
    Participants received modakafusp alfa 0.3 mg/kg, infusion, IV, Q2W on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG005
    title
    Part 1 (Dose Escalation) Schedule B: Modakafusp Alfa 0.3 mg/kg
  7. description
    Participants received modakafusp alfa 0.4 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
    id
    OG006
    title
    Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.4 mg/kg
  8. description
    Participants received modakafusp alfa 0.75 mg/kg, infusion, IV, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
    id
    OG007
    title
    Part 1 (Dose Escalation) Schedule C: Modakafusp Alfa 0.75 mg/kg
  9. description
    Participants received modakafusp alfa 0.75 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG008
    title
    Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 0.75 mg/kg
  10. description
    Participants received modakafusp alfa 1.5 mg/kg infusion, IV, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG009
    title
    Part 1 (Dose Escalation) Schedule D: Modakafusp Alfa 1.5 mg/kg
param Type
MEDIAN
population Description
The PK Analysis Set included participants from the SAS who had sufficient data to calculate at least 1 PK parameter for modakafusp alfa. Overall number of participants analyzed is the number of participants with data available for analysis. Number analyzed is the number of participants with data available for analysis during the specified time-point.
reporting Status
POSTED
time Frame
Part 1:Schedule A:Day 1&15 in Cycles 1&2; Schedule B: Day1&15 in Cycles 1&2; Schedule C:Day1 in Cycles 1&2; Schedule D: Day 1 in Cycles 1&2: Pre-infusion&at multiple times post-infusion (cycle length was 28 days for Schedule A, B&D;21 days for Schedule C)
title
Part 1: Tmax: Time to Reach the Cmax for Modakafusp Alfa
type
SECONDARY
unit Of Measure
hours

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice