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NCT04140162 · FLOW

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Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment for Newly Diagnosed Multiple Myeloma (MM) With Upfront Daratumumab-based Therapy · Source last updated 2026-07-28

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

groups
  1. description
    * Induction regimen with Dara-Rd in all study subjects, weeks 1-24 * Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36 * Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88 * Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses). Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab. Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
    id
    FG000
    title
    Dara-Rd Followed by Dara-RVd
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Noncompliance
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        56
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        46
      comment
      Participants that are positive move on to consolidation
      type
      MRD +
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      comment
      Participants that are negative move on to maintenance
      type
      MRD -
    4. achievements
      1. group Id
        FG000
        num Subjects
        51
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Induction
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      off tx after MRD2, patient chose to go to ASCT off protocol
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Subject moved out of state
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Alternative Therapy
    milestones
    1. achievements
      1. comment
        MRD- subjects move directly to Maintenance
        group Id
        FG000
        num Subjects
        46
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      MRD2+ and Received ACST
    3. achievements
      1. group Id
        FG000
        num Subjects
        28
      type
      MRD2+ But no ACST
    4. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      MRD-
    5. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Consolidation
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Noncompliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other complicating conditions
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Continue to hold myeloma therapy given high-copay
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      discontinuation of health insurance
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Moving to transplant
    milestones
    1. achievements
      1. comment
        1 subject completed Induction but did not progress to Consolidation due to disease progression. 2 subjects started Consolidation but did not progress to Maintenance due to disease progression. 1 subject completed Consolidation and moved to Maintenance due to lack of support network required for ASCT procedure, then came off treatment for ASCT as primary therapy.
        group Id
        FG000
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Maintenance
pre Assignment Details
1 subject enrolled, but did not start treatment due to physician discretion.
recruitment Details
15 patients are still active in the Maintenance cohort. Completion data will be updated once all patients have completed treatment
Complete source fields
groups
  1. description
    * Induction regimen with Dara-Rd in all study subjects, weeks 1-24 * Consolidation regimen with Dara-RVd in post-induction MRD+ population, weeks 25-36 * Maintenance regimen with Daratumumab and Lenalidomide (Dara-R) in all study subjects, weeks 37-88 * Maintenance regimen with lenalidomide (R) until progression or intolerance Daratumumab: Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses). Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36) Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88) The sites will then transition existing patient to SQ daratumumab. New patients will be started on SQ 1800mg daratumumab. Induction- Cycles 1-2 (days 1, 8,15, 22), Cycles 3-6 (Weeks 9-24- two weeks (days 1, 15 ) Consolidation- Every 4 weeks on day 1 Maintenance- Every 8 weeks on day 1 Lenalidomide: Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24). Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36). Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression. Bortezomib: Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36) Dexamethasone: Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
    id
    FG000
    title
    Dara-Rd Followed by Dara-RVd
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Noncompliance
    3. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        56
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        46
      comment
      Participants that are positive move on to consolidation
      type
      MRD +
    3. achievements
      1. group Id
        FG000
        num Subjects
        5
      comment
      Participants that are negative move on to maintenance
      type
      MRD -
    4. achievements
      1. group Id
        FG000
        num Subjects
        51
      type
      COMPLETED
    5. achievements
      1. group Id
        FG000
        num Subjects
        5
      type
      NOT COMPLETED
    title
    Induction
  2. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      off tx after MRD2, patient chose to go to ASCT off protocol
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Subject moved out of state
    3. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Alternative Therapy
    milestones
    1. achievements
      1. comment
        MRD- subjects move directly to Maintenance
        group Id
        FG000
        num Subjects
        46
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      type
      MRD2+ and Received ACST
    3. achievements
      1. group Id
        FG000
        num Subjects
        28
      type
      MRD2+ But no ACST
    4. achievements
      1. group Id
        FG000
        num Subjects
        11
      type
      MRD-
    5. achievements
      1. group Id
        FG000
        num Subjects
        43
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        3
      type
      NOT COMPLETED
    title
    Consolidation
  3. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Physician Decision
    2. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Withdrawal by Subject
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Noncompliance
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Adverse Event
    5. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Death
    6. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Other complicating conditions
    7. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Continue to hold myeloma therapy given high-copay
    8. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      discontinuation of health insurance
    9. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Moving to transplant
    milestones
    1. achievements
      1. comment
        1 subject completed Induction but did not progress to Consolidation due to disease progression. 2 subjects started Consolidation but did not progress to Maintenance due to disease progression. 1 subject completed Consolidation and moved to Maintenance due to lack of support network required for ASCT procedure, then came off treatment for ASCT as primary therapy.
        group Id
        FG000
        num Subjects
        44
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        30
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        14
      type
      NOT COMPLETED
    title
    Maintenance
pre Assignment Details
1 subject enrolled, but did not start treatment due to physician discretion.
recruitment Details
15 patients are still active in the Maintenance cohort. Completion data will be updated once all patients have completed treatment

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Preserved source evidence · Independent clinical review pending · Not medical advice