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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.

groups
  1. description
    Participants received TAK-981 60 milligrams (mg), infusion, intravenously, twice weekly (BIW) 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
    FG000
    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
    FG001
    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 (QW) 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
    FG002
    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
    FG003
    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
    FG004
    title
    Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg
  6. description
    Participants were planned to receive TAK-981, infusion, intravenously, in combination with daratumumab and hyaluronidase-fihj, injection, subcutaneously, once weekly in 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. No participants were enrolled in this arm as this study was terminated early before start of enrolment in Phase 1b, Part 2.
    id
    FG005
    title
    Phase 1b, Part 2: TAK-981 + Daratumumab + Hyaluronidase-fihj
  7. description
    Participants were planned to receive TAK-981 recommended phase 2 dose (RP2D), infusion, intravenously, in combination with an anti-CD38 antibody (mezagitamab or daratumumab and hyaluronidase-fihj), injection, subcutaneously, for up to 24 cycles or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days. No participants were enrolled in this arm as this study was terminated early before start of enrolment in Phase 2.
    id
    FG006
    title
    Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Study terminated by sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. comment
        The study was terminated before start of enrolment in Phase 1b, Part 2. Hence, no participants were enrolled in Phase 1b Part 2.
        group Id
        FG005
        num Subjects
        0
      7. comment
        The study was terminated before start of enrolment in Phase 2. Hence, no participants were enrolled in Phase 2.
        group Id
        FG006
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This study consisted of Phase 1b and 2. Phase 1b (Dose Escalation) had two parts (Parts 1 and 2) and Phase 2 (Dose Expansion) was single part. Phase 1b- Part 2 and Phase 2 were not conducted, as study was terminated early after completion of Phase 1b Part 1 due to business reasons and therefore, no data for Phase 1b Part 2 and Phase 2 was collected and reported.
recruitment Details
Participants took part in the study at 10 investigative sites in the United States and Canada from 20 April 2021 to 09 November 2023. Participants with diagnosis of Relapsed and/or Refractory Multiple Myeloma (RRMM) were enrolled in Phase 1b Part 1 to receive TAK-981 in combination with mezagitamab.
Complete source fields
groups
  1. description
    Participants received TAK-981 60 milligrams (mg), infusion, intravenously, twice weekly (BIW) 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
    FG000
    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
    FG001
    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 (QW) 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
    FG002
    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
    FG003
    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
    FG004
    title
    Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg
  6. description
    Participants were planned to receive TAK-981, infusion, intravenously, in combination with daratumumab and hyaluronidase-fihj, injection, subcutaneously, once weekly in 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. No participants were enrolled in this arm as this study was terminated early before start of enrolment in Phase 1b, Part 2.
    id
    FG005
    title
    Phase 1b, Part 2: TAK-981 + Daratumumab + Hyaluronidase-fihj
  7. description
    Participants were planned to receive TAK-981 recommended phase 2 dose (RP2D), infusion, intravenously, in combination with an anti-CD38 antibody (mezagitamab or daratumumab and hyaluronidase-fihj), injection, subcutaneously, for up to 24 cycles or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days. No participants were enrolled in this arm as this study was terminated early before start of enrolment in Phase 2.
    id
    FG006
    title
    Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        4
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Study terminated by sponsor
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        2
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Other
    5. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        1
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      Lost to Follow-up
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. comment
        The study was terminated before start of enrolment in Phase 1b, Part 2. Hence, no participants were enrolled in Phase 1b Part 2.
        group Id
        FG005
        num Subjects
        0
      7. comment
        The study was terminated before start of enrolment in Phase 2. Hence, no participants were enrolled in Phase 2.
        group Id
        FG006
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        0
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        8
      6. group Id
        FG005
        num Subjects
        0
      7. group Id
        FG006
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
This study consisted of Phase 1b and 2. Phase 1b (Dose Escalation) had two parts (Parts 1 and 2) and Phase 2 (Dose Expansion) was single part. Phase 1b- Part 2 and Phase 2 were not conducted, as study was terminated early after completion of Phase 1b Part 1 due to business reasons and therefore, no data for Phase 1b Part 2 and Phase 2 was collected and reported.
recruitment Details
Participants took part in the study at 10 investigative sites in the United States and Canada from 20 April 2021 to 09 November 2023. Participants with diagnosis of Relapsed and/or Refractory Multiple Myeloma (RRMM) were enrolled in Phase 1b Part 1 to receive TAK-981 in combination with mezagitamab.

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Preserved source evidence · Not medical advice