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NCT04776018 · OUTCOME

Phase 1b, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) Based on NCI CTCAE Version 5.0

A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) · Source last updated 2024-10-02

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Cycle 1 (Cycle length = 28 Days)

What was measured

DLTs were evaluated according to NCI CTCAE version 5.0. Grade 5 AE. Hematologic toxicity: Nonfebrile Grade 4 neutropenia/Grade greater than or equal to (\>=) 3 febrile neutropenia; Significant Grade 3 thrombocytopenia; Grade 4 anemia or thrombocytopenia. Nonhematologic Grade 3 or higher toxicities; Grade 2 nonhematologic toxicities leading to dose reduction/discontinuation. Delay in Cycle 2 by greater than (\>) 14 days or missed \>1 planned doses of TAK-981/monoclonal antibody (mAb) in Cycle 1 due to TEAEs.

Analysis population: DLT-evaluable analysis set included participants who received at least 75 precent (%) of planned TAK-981 doses, all mAb doses, and have completed Cycle 1 procedures, or experienced a DLT in Cycle 1 in the phase 1 portion of the trial.

Groups in this outcome

Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg

Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.

Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg

Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.

Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg

Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.

Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg

Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.

Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg

Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 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
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg8
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg7

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg0Not reportedNot reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg0Not reportedNot reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg1Not reportedNot reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg1Not reportedNot reportedNot reportedNot reported
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
      3. group Id
        OG002
        value
        1
      4. group Id
        OG003
        value
        1
      5. group Id
        OG004
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      8
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      7
    units
    Participants
description
DLTs were evaluated according to NCI CTCAE version 5.0. Grade 5 AE. Hematologic toxicity: Nonfebrile Grade 4 neutropenia/Grade greater than or equal to (\>=) 3 febrile neutropenia; Significant Grade 3 thrombocytopenia; Grade 4 anemia or thrombocytopenia. Nonhematologic Grade 3 or higher toxicities; Grade 2 nonhematologic toxicities leading to dose reduction/discontinuation. Delay in Cycle 2 by greater than (\>) 14 days or missed \>1 planned doses of TAK-981/monoclonal antibody (mAb) in Cycle 1 due to TEAEs.
groups
  1. description
    Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG000
    title
    Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg
  2. description
    Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG001
    title
    Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg
  3. description
    Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG002
    title
    Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg
  4. description
    Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG003
    title
    Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg
  5. description
    Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
    id
    OG004
    title
    Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg
param Type
COUNT_OF_PARTICIPANTS
population Description
DLT-evaluable analysis set included participants who received at least 75 precent (%) of planned TAK-981 doses, all mAb doses, and have completed Cycle 1 procedures, or experienced a DLT in Cycle 1 in the phase 1 portion of the trial.
reporting Status
POSTED
time Frame
Cycle 1 (Cycle length = 28 Days)
title
Phase 1b, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) Based on NCI CTCAE Version 5.0
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice