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NCT05090566 · FLOW

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MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma · Source last updated 2026-04-24

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

groups
  1. description
    Participants with relapsed/refractory multiple myeloma (RRMM) received elranatamab 4 milligram (mg) subcutaneously (SC) on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally twice a day (BID).
    id
    FG000
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1
  2. description
    Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
    id
    FG001
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2
  3. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
    id
    FG002
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3
  4. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally once daily (QD).
    id
    FG003
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A
  5. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.
    id
    FG004
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A
  6. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and 44 mg on Cycle 0 Day 8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2.
    id
    FG005
    title
    SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        5
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        4
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        12
      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
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Outcome measures data are reported at Primary Completion Date, and data is disclosed for only those outcome measures whose analysis were final. Remaining outcome measures' data would be reported upon their complete analyses at study completion date. Safety summaries reported are until October 2025 (approximately up to 48 months).
recruitment Details
A total of 46 participants were enrolled in this study. Study had two sub-studies: sub-study A (SSA) and sub-study B (SSB). Phase 1b and Phase 2 were planned for SSA, while Phase 1b for SSB. Phase 2 of SSA was not conducted, based on sponsor's decision. Hence there is no data reported for Phase 2 in any section of the results' record.
Complete source fields
groups
  1. description
    Participants with relapsed/refractory multiple myeloma (RRMM) received elranatamab 4 milligram (mg) subcutaneously (SC) on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 4 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally twice a day (BID).
    id
    FG000
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 1
  2. description
    Participants with RRMM received elranatamab 4 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 8 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 12 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
    id
    FG001
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 2
  3. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally BID.
    id
    FG002
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3
  4. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 32 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally once daily (QD).
    id
    FG003
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 3A
  5. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and thereafter 76 mg weekly during each cycle (1 cycle = 4 weeks) and Nirogacestat 100 mg orally QD.
    id
    FG004
    title
    SSA, Phase 1b: Elranatamab + Nirogacestat, Dose Level 4A
  6. description
    Participants with RRMM received elranatamab 12 mg SC on Cycle 0 Day 1 (7 days prior to Cycle 1 Day 1) and 32 mg on Cycle 0 Day 4 (3 days prior to Cycle 1 Day 1) \[priming dose\] and 44 mg on Cycle 0 Day 8 and thereafter 44 mg weekly during each cycle (1 cycle = 4 weeks) and Lenalidomide 15 mg QD for 21 days and Dexamethasone 20 mg weekly on Cycle 1 and 2.
    id
    FG005
    title
    SSB, Phase 1b: Elranatamab + Lenalidomide + Dexamethasone, Dose Level 1
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        1
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        5
      type
      Death
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        2
      4. group Id
        FG003
        num Subjects
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        3
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        0
      2. group Id
        FG001
        num Subjects
        2
      3. group Id
        FG002
        num Subjects
        5
      4. group Id
        FG003
        num Subjects
        9
      5. group Id
        FG004
        num Subjects
        5
      6. group Id
        FG005
        num Subjects
        4
      type
      Ongoing
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        12
      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
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        2
      2. group Id
        FG001
        num Subjects
        6
      3. group Id
        FG002
        num Subjects
        10
      4. group Id
        FG003
        num Subjects
        10
      5. group Id
        FG004
        num Subjects
        6
      6. group Id
        FG005
        num Subjects
        12
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Outcome measures data are reported at Primary Completion Date, and data is disclosed for only those outcome measures whose analysis were final. Remaining outcome measures' data would be reported upon their complete analyses at study completion date. Safety summaries reported are until October 2025 (approximately up to 48 months).
recruitment Details
A total of 46 participants were enrolled in this study. Study had two sub-studies: sub-study A (SSA) and sub-study B (SSB). Phase 1b and Phase 2 were planned for SSA, while Phase 1b for SSB. Phase 2 of SSA was not conducted, based on sponsor's decision. Hence there is no data reported for Phase 2 in any section of the results' record.

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

Preserved source evidence · Not medical advice