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NCT02186834 · FLOW

Participant flow

Selinexor (KPT-330) and Liposomal Doxorubicin For Relapsed and Refractory Multiple Myeloma · Source last updated 2023-01-04

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

groups
  1. description
    Dose 1: Participants were administered Lipodox 20 mg/m\^2 via IV on Day 1 of cycle. Selinexor at 40 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG000
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1
  2. description
    Dose 2: Participants were administered Lipodox 20 mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG001
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2
  3. description
    Dose 1m: Participants were administered Lipodox 20 mg/m\^2 on Day 1 of cycle. Selinexor at 60 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG002
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1m
  4. description
    Dose 2m: Participants were administered Lipodox 20mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG003
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2m
  5. description
    Dose 3m: Participants were administered Lipodox 20mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,3, 8 and 10 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG004
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 3m
  6. description
    Phase 2 Dose: Participants were administered Lipodox 20 mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG005
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- RP2D
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
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        0
      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
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Escalation
  2. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Died prior to treatment
    milestones
    1. 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
        14
      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
        13
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Treatment at RP2D
pre Assignment Details
6 of the 14 participants treated at RP2D moved on from Dose 2m arm in the dose escalation portion of study.
recruitment Details
Participants were recruited at Moffitt Cancer Center and Karmanos Cancer Center September 2014 through May 2017.
Complete source fields
groups
  1. description
    Dose 1: Participants were administered Lipodox 20 mg/m\^2 via IV on Day 1 of cycle. Selinexor at 40 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG000
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1
  2. description
    Dose 2: Participants were administered Lipodox 20 mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG001
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2
  3. description
    Dose 1m: Participants were administered Lipodox 20 mg/m\^2 on Day 1 of cycle. Selinexor at 60 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG002
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 1m
  4. description
    Dose 2m: Participants were administered Lipodox 20mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG003
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 2m
  5. description
    Dose 3m: Participants were administered Lipodox 20mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,3, 8 and 10 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG004
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- Dose 3m
  6. description
    Phase 2 Dose: Participants were administered Lipodox 20 mg/m\^2 on Day 1 of cycle. Selinexor at 80 mg was given orally on days 1,8 and 15 of the cycle. Dexamethasone at 40 mg was given orally on days 1, 8 and 15.
    id
    FG005
    title
    Selinexor, Liposomal Doxorubicin and Dexamethasone- RP2D
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
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      Death
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        7
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        0
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        6
      2. group Id
        FG001
        num Subjects
        3
      3. group Id
        FG002
        num Subjects
        0
      4. group Id
        FG003
        num Subjects
        6
      5. group Id
        FG004
        num Subjects
        4
      6. group Id
        FG005
        num Subjects
        0
      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
        0
      6. group Id
        FG005
        num Subjects
        0
      type
      NOT COMPLETED
    title
    Dose Escalation
  2. 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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      Died prior to treatment
    milestones
    1. 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
        14
      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
        13
      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
        0
      5. group Id
        FG004
        num Subjects
        0
      6. group Id
        FG005
        num Subjects
        1
      type
      NOT COMPLETED
    title
    Treatment at RP2D
pre Assignment Details
6 of the 14 participants treated at RP2D moved on from Dose 2m arm in the dose escalation portion of study.
recruitment Details
Participants were recruited at Moffitt Cancer Center and Karmanos Cancer Center September 2014 through May 2017.

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

Preserved source evidence · Not medical advice