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NCT00555906 · BASELINE

Baseline characteristics

An Investigational Drug, Palbociclib (PD-0332991), Is Being Studied In Combination With Velcade And Dexamethasone In Patients With Multiple Myeloma. Patients Must Have Received Prior Treatment For Multiple Myeloma. · Source last updated 2015-03-19

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

denoms
  1. counts
    1. group Id
      BG000
      value
      9
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      32
    4. group Id
      BG003
      value
      53
    units
    Participants
groups
  1. description
    Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    BG000
    title
    Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
  2. description
    Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    BG001
    title
    Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule B)
  3. description
    Included all participants who received palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    BG002
    title
    Palbociclib + Bortezomib + Dexamethasone (Phase2:ScheduleB)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      18 to 44 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          24
      title
      45 to 64 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          26
      title
      Greater than or equal to (>=) 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          30
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all enrolled participants.
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      9
    2. group Id
      BG001
      value
      12
    3. group Id
      BG002
      value
      32
    4. group Id
      BG003
      value
      53
    units
    Participants
groups
  1. description
    Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    BG000
    title
    Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)
  2. description
    Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    BG001
    title
    Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule B)
  3. description
    Included all participants who received palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m\^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
    id
    BG002
    title
    Palbociclib + Bortezomib + Dexamethasone (Phase2:ScheduleB)
  4. description
    Total of all reporting groups
    id
    BG003
    title
    Total
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          0
        4. group Id
          BG003
          value
          3
      title
      18 to 44 years
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          7
        3. group Id
          BG002
          value
          13
        4. group Id
          BG003
          value
          24
      title
      45 to 64 years
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        2. group Id
          BG001
          value
          4
        3. group Id
          BG002
          value
          19
        4. group Id
          BG003
          value
          26
      title
      Greater than or equal to (>=) 65 years
    param Type
    NUMBER
    title
    Age, Customized
    unit Of Measure
    participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        2. group Id
          BG001
          value
          1
        3. group Id
          BG002
          value
          17
        4. group Id
          BG003
          value
          23
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          4
        2. group Id
          BG001
          value
          11
        3. group Id
          BG002
          value
          15
        4. group Id
          BG003
          value
          30
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
population Description
Full analysis set (FAS) included all enrolled participants.

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

Preserved source evidence · Not medical advice