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NCT04776018 · OUTCOME

Phases 1b, Part 1: Progression-free Survival (PFS) Based on IMWG Criteria

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
MEDIAN
Unit
months
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose of study drug to date of PD or death, whichever occurred first (up to 12 months)

What was measured

PFS was defined as time from the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first. PD was defined as increase of \>25% from lowest response value in any one or more of the following: a) Serum M-component and/or (the absolute increase must be \>0.5 g/dL). b) Urine M-component and/or (the absolute increase must be \>200 mg/24h). c) Only in participants without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dL. d) Bone marrow plasma cell percentage; the absolute percentage must be \>10%. e) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. f) Development of hypercalcaemia (corrected serum calcium \>11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

Analysis population: Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.

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 mg10
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg8

Reported measurements

Source class 1
Values in months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg7.9Not reported5.7NAUpper limit of 95% CI could not be estimated due to insufficient events.
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg1.0Not reported1.0NAUpper limit of 95% CI could not be estimated due to insufficient events.
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg1.2Not reported1.02.7Not reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg1.6Not reported1.2NAUpper limit of 95% CI could not be estimated due to insufficient events.
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg3.7Not reported2.45.6Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. comment
        Upper limit of 95% CI could not be estimated due to insufficient events.
        group Id
        OG000
        lower Limit
        5.7
        upper Limit
        NA
        value
        7.9
      2. comment
        Upper limit of 95% CI could not be estimated due to insufficient events.
        group Id
        OG001
        lower Limit
        1.0
        upper Limit
        NA
        value
        1.0
      3. group Id
        OG002
        lower Limit
        1.0
        upper Limit
        2.7
        value
        1.2
      4. comment
        Upper limit of 95% CI could not be estimated due to insufficient events.
        group Id
        OG003
        lower Limit
        1.2
        upper Limit
        NA
        value
        1.6
      5. group Id
        OG004
        lower Limit
        2.4
        upper Limit
        5.6
        value
        3.7
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      10
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      8
    units
    Participants
description
PFS was defined as time from the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first. PD was defined as increase of \>25% from lowest response value in any one or more of the following: a) Serum M-component and/or (the absolute increase must be \>0.5 g/dL). b) Urine M-component and/or (the absolute increase must be \>200 mg/24h). c) Only in participants without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be \>10 mg/dL. d) Bone marrow plasma cell percentage; the absolute percentage must be \>10%. e) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. f) Development of hypercalcaemia (corrected serum calcium \>11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.
dispersion Type
95% Confidence Interval
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
MEDIAN
population Description
Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.
reporting Status
POSTED
time Frame
From the first dose of study drug to date of PD or death, whichever occurred first (up to 12 months)
title
Phases 1b, Part 1: Progression-free Survival (PFS) Based on IMWG Criteria
type
SECONDARY
unit Of Measure
months

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Preserved source evidence · Not medical advice