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NCT03215030 · OUTCOME

Part 2: Cmax: Maximum Observed Serum Concentration 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
GEOMETRIC_MEAN
Unit
ng/mL
Interval / dispersion
Geometric Coefficient of Variation
Time frame
Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)

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 2 (Dose Expansion): 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 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg

Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.

Part 2 (Dose Expansion): 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.

Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg

Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, 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 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg7
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg3
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg21
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg6

Reported measurements

Cycle 1 Day 1

Analysis denominator · Participants

GroupSource count
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg7
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg3
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg21
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg6
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg354083.7Not reportedNot reportedNot reported
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg433023.7Not reportedNot reportedNot reported
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg3210025.4Not reportedNot reportedNot reported
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg3570020.0Not reportedNot reportedNot reported
Cycle 2 Day 1

Analysis denominator · Participants

GroupSource count
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg6
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg3
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg16
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg4
Values in ng/mL · Interval/dispersion: Geometric Coefficient of Variation
GroupValueSpreadLowerUpperComment
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg345051.2Not reportedNot reportedNot reported
Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg387026.6Not reportedNot reportedNot reported
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg3420024.6Not reportedNot reportedNot reported
Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg3610025.6Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        83.7
        value
        3540
      2. group Id
        OG001
        spread
        23.7
        value
        4330
      3. group Id
        OG002
        spread
        25.4
        value
        32100
      4. group Id
        OG003
        spread
        20.0
        value
        35700
    denoms
    1. counts
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        21
      4. group Id
        OG003
        value
        6
      units
      Participants
    title
    Cycle 1 Day 1
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        51.2
        value
        3450
      2. group Id
        OG001
        spread
        26.6
        value
        3870
      3. group Id
        OG002
        spread
        24.6
        value
        34200
      4. group Id
        OG003
        spread
        25.6
        value
        36100
    denoms
    1. counts
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        16
      4. group Id
        OG003
        value
        4
      units
      Participants
    title
    Cycle 2 Day 1
denoms
  1. counts
    1. group Id
      OG000
      value
      7
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      21
    4. group Id
      OG003
      value
      6
    units
    Participants
dispersion Type
Geometric Coefficient of Variation
groups
  1. 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
    OG000
    title
    Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg
  2. description
    Participants received modakafusp alfa 0.4 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q3W on Day 1 of each 21-day treatment cycle until treatment discontinuation.
    id
    OG001
    title
    Part 2 (Dose Expansion): Schedule C: Modakafusp Alfa 0.4 mg/kg + Dexamethasone 40 mg
  3. 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
    OG002
    title
    Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg
  4. description
    Participants received modakafusp alfa 1.5 mg/kg infusion, IV, and dexamethasone 40 mg, orally, Q4W on Day 1 of each 28-day treatment cycle until treatment discontinuation.
    id
    OG003
    title
    Part 2 (Dose Expansion): Schedule D: Modakafusp Alfa 1.5 mg/kg + Dexamethasone 40 mg
param Type
GEOMETRIC_MEAN
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
Schedule C and D: Pre-infusion and at multiple times post-infusion on Day 1 of Cycles 1 and 2: (cycle length was 21 days for Schedule C and 28 days for Schedule D)
title
Part 2: Cmax: Maximum Observed Serum Concentration for Modakafusp Alfa
type
SECONDARY
unit Of Measure
ng/mL

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

Preserved source evidence · Not medical advice