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NCT00450814 · FLOW

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Vaccine Therapy With or Without Cyclophosphamide in Treating Patients With Recurrent or Refractory Multiple Myeloma · Source last updated 2019-12-16

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

groups
  1. description
    Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG000
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 1
  2. description
    Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG001
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 2
  3. description
    Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG002
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 3
  4. description
    Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG003
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
  5. description
    Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG004
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
  6. description
    Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG005
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
  7. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    FG006
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1
  8. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    FG007
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
  9. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    FG008
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
  10. description
    Cohort A patients (relapsed or refractory multiple myeloma who have exhausted all therapeutic options) receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
    id
    FG009
    title
    Phase II (Acetaminophen + Benadryl + MV-NIS) Cohort A
  11. description
    Cohort B patients (relapsing from VGPR or CR and have not \> received myeloma directed therapy for at least 12 weeks) receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
    id
    FG010
    title
    Phase II (Acetaminophen + Benadryl + MV-NIS) Cohort B
periods
  1. drop Withdraws
    1. reasons
      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
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Failed to complete the initial therapy
    2. reasons
      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
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Patient withdrawal prior to treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        12
      11. group Id
        FG010
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        4
      type
      COMPLETED
    3. 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
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Phase I: INITIALLY CLOSED ON 12/17/2009 AND STAGE 2 BEGUN; HOWEVER, DUE TO NEW MANUFACTURING CAPABILITIES, STAGE 1 RE-OPENED ON October 13, 2011, FOR DOSE LEVELS 5 AND 6. Phase II: Accrual to Cohort A closed due to failed interim analysis. Cohort B closed due to lack of accrual.
Complete source fields
groups
  1. description
    Patients receive 1x10\^6 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG000
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 1
  2. description
    Patients receive 1x10\^7 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG001
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 2
  3. description
    Patients receive 1x10\^8 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG002
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 3
  4. description
    Patients receive 1x10\^9 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG003
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 4
  5. description
    Patients receive 1x10\^10 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG004
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 5
  6. description
    Patients receive 1x10\^11 MV-NIS (TCID50) IV over 1 hour on day 1.
    id
    FG005
    title
    Phase I: Stage 1 (MV-NIS Alone) Dose Level 6
  7. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then (Stage 1 MTD/100=10\^7) MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    FG006
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 1
  8. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 3 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    FG007
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 2
  9. description
    Patients receive 10 mg/kg cyclophosphamide IV over 30 minutes and then 9 x 10\^7 MV-NIS (TCID50) IV over 1 hour 2 days later. (Temporarily closed to accrual on 10/13/11)
    id
    FG008
    title
    Phase I: Stage 2 (MV-NIS and Cyclophosphamide) Dose Level 3
  10. description
    Cohort A patients (relapsed or refractory multiple myeloma who have exhausted all therapeutic options) receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
    id
    FG009
    title
    Phase II (Acetaminophen + Benadryl + MV-NIS) Cohort A
  11. description
    Cohort B patients (relapsing from VGPR or CR and have not \> received myeloma directed therapy for at least 12 weeks) receive 650 mg Acetaminophen and 50 mg Benadryl orally 30 minutes prior to MV-NIS then receive MV-NIS IV over 1 hour on day 1.
    id
    FG010
    title
    Phase II (Acetaminophen + Benadryl + MV-NIS) Cohort B
periods
  1. drop Withdraws
    1. reasons
      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
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        0
      11. group Id
        FG010
        num Subjects
        0
      type
      Failed to complete the initial therapy
    2. reasons
      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
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      Patient withdrawal prior to treatment
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        4
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        7
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        12
      11. group Id
        FG010
        num Subjects
        4
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        3
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        3
      4. group Id
        FG003
        num Subjects
        3
      5. group Id
        FG004
        num Subjects
        3
      6. group Id
        FG005
        num Subjects
        6
      7. group Id
        FG006
        num Subjects
        3
      8. group Id
        FG007
        num Subjects
        3
      9. group Id
        FG008
        num Subjects
        2
      10. group Id
        FG009
        num Subjects
        11
      11. group Id
        FG010
        num Subjects
        4
      type
      COMPLETED
    3. 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
        1
      5. group Id
        FG004
        num Subjects
        1
      6. group Id
        FG005
        num Subjects
        1
      7. group Id
        FG006
        num Subjects
        0
      8. group Id
        FG007
        num Subjects
        0
      9. group Id
        FG008
        num Subjects
        0
      10. group Id
        FG009
        num Subjects
        1
      11. group Id
        FG010
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
Phase I: INITIALLY CLOSED ON 12/17/2009 AND STAGE 2 BEGUN; HOWEVER, DUE TO NEW MANUFACTURING CAPABILITIES, STAGE 1 RE-OPENED ON October 13, 2011, FOR DOSE LEVELS 5 AND 6. Phase II: Accrual to Cohort A closed due to failed interim analysis. Cohort B closed due to lack of accrual.

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

Preserved source evidence · Not medical advice