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NCT04776018 · OUTCOME

Phase 1b, Part 1: ORR Based on International Myeloma Working Group (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
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
From the first dose of study drug until first disease progression (PD) or death, whichever occurred first (up to 12 months)

What was measured

ORR: percentage of participants who achieve complete response (CR) or partial response (PR) or better per investigator assessment by IMWG.CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow (BM). PR: \>50 percent (%) reduction of serum M-protein and reduction in 24 hours (h) urinary M-protein by \>90% or to less than (\<) 200 milligrams per 24 hour (mg/24 h); If the serum and urine M-protein were unmeasurable, \>50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, \>50% reduction in plasma cells is required in place of M-protein, provided baseline BM plasma cell percentage was \>30%. In addition to the above listed criteria, if present at baseline, a \>50% reduction in the size of soft tissue plasmacytomas is also required.

Analysis population: Response-evaluable analysis set included participants with measurable disease at baseline and at least 1 posttreatment evaluation.

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 mg9
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg3
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg6

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg0.0Not reported0.070.8Not reported
Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg0.0Not reported0.070.8Not reported
Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg0.0Not reported0.033.6Not reported
Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg0.0Not reported0.070.8Not reported
Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg16.7Not reported0.464.1Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0.0
      2. group Id
        OG001
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0.0
      3. group Id
        OG002
        lower Limit
        0.0
        upper Limit
        33.6
        value
        0.0
      4. group Id
        OG003
        lower Limit
        0.0
        upper Limit
        70.8
        value
        0.0
      5. group Id
        OG004
        lower Limit
        0.4
        upper Limit
        64.1
        value
        16.7
denoms
  1. counts
    1. group Id
      OG000
      value
      3
    2. group Id
      OG001
      value
      3
    3. group Id
      OG002
      value
      9
    4. group Id
      OG003
      value
      3
    5. group Id
      OG004
      value
      6
    units
    Participants
description
ORR: percentage of participants who achieve complete response (CR) or partial response (PR) or better per investigator assessment by IMWG.CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow (BM). PR: \>50 percent (%) reduction of serum M-protein and reduction in 24 hours (h) urinary M-protein by \>90% or to less than (\<) 200 milligrams per 24 hour (mg/24 h); If the serum and urine M-protein were unmeasurable, \>50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, \>50% reduction in plasma cells is required in place of M-protein, provided baseline BM plasma cell percentage was \>30%. In addition to the above listed criteria, if present at baseline, a \>50% reduction in the size of soft tissue plasmacytomas is also required.
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
NUMBER
population Description
Response-evaluable analysis set included participants with measurable disease at baseline and at least 1 posttreatment evaluation.
reporting Status
POSTED
time Frame
From the first dose of study drug until first disease progression (PD) or death, whichever occurred first (up to 12 months)
title
Phase 1b, Part 1: ORR Based on International Myeloma Working Group (IMWG) Criteria
type
SECONDARY
unit Of Measure
percentage of participants

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Preserved source evidence · Not medical advice