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NCT03117361 · BASELINE

Baseline characteristics

Trial of Plitidepsin (Aplidin®) in Combination With Bortezomib and Dexamethasone in Multiple Myeloma Patients Double Refractory to Bortezomib and Lenalidomide · Source last updated 2020-12-02

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
      10
    units
    Participants
groups
  1. description
    Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.
    id
    BG000
    title
    Experimental
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          43
          upper Limit
          72
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Italy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        PS 0
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        PS 1
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        PS 2
    description
    ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours PS 3 Capable of only limited selfcare confined to bed or chair more than 50% of waking hours PS 4 Completely disabled cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG PS
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Secretory IgA
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Secretory IgG
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Secretory Kappa light-chain disease
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Secretory Lambda light-chain disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Multiple myeloma type at diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        IIA
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        IIIA
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        IIIB
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Missing
    description
    4 patients had missing data in stage and sub-classification Stage I: All of the following: Hemoglobin\>10 g/dl,Serum calcium\<10.5 mg/dL, normal bone structure,IgG\<5 g/dL; IgA\<3 g/dL, Urine light chain M-component\<4 g/24h Stage II:Fitting neither Stage I nor Stage III Stage III: One or more of the following: Hemoglobin\<8.5 g/dL, Serum calcium\>12 mg/dL,Advanced lytic bone lesions,IgG\>7 g/dL; IgA\> 5 g/dL,Urine light chain M-component\>12 g/24h Subclassification: A, serum creatinine\<2.0 mg/dL;B, serum creatinine\>2.0 mg/dL
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Durie-Salmon stage and subclassification at diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        ISS I
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        ISS II
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        ISS III
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Not done
    description
    ISS, International Staging System ISS stage I was defined as serum β2-microglobulin level less than 3.5 mg/L and serum albumin level ≥ 3.5 g/dL. ISS stage II included all patients with neither stage I nor stage III disease. ISS stage III was defined as serum β2-microglobulin level ≥ 5.5 mg/L, irrespective of serum albumin level
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS stage at diagnosis
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Stage II
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Stage III
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Non available genetic results
    description
    R-ISS, Revised International Staging System Stage I: Serum β2 microglobulin\<3.5 mg/l; Serum albumin≥3.5 g/dl;Standard-risk chromosomal abnormalities (CA);Normal LDH Stage II: Not R-ISS stage I or III Stage III: Serum β2 microglobulin≥5.5 mg/L and either High-risk CA by FISH OR High LDH
    param Type
    COUNT_OF_PARTICIPANTS
    title
    R-ISS stage at study entry
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        High risk
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Standard risk
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Non available genetic results
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic at study entry
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        Primary Refractory
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Relapsed and refractory
    description
    Total refractory MM included 2 categories of refractory: * Primary Refractory: disease that was non-responsive in patients who had never achieved a MR or better, with any therapy. It included patients who never achieved MR or better, in whom there was no significant change in M-protein and no evidence of clinical progression, as well as primary, refractory PD where patients met criteria for true PD. * Relapsed and refractory: disease that was non-responsive while on salvage therapy, or progressed within 60 days of the last therapy in patients who had achieved MR or better at some point
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease status with respect to last prior therapy
    unit Of Measure
    Participants
Complete source fields
denoms
  1. counts
    1. group Id
      BG000
      value
      10
    units
    Participants
groups
  1. description
    Plitidepsin was to be administered as a 3-hour (h) intravenous (i.v.) infusion at a dose of 5 mg/m2, on Day (D) 1 and 15, every four weeks (q4wk); BTZ was to be administered as a subcutaneous (s.c.) injection at a dose of 1.3 mg/m2 on D1, 4, 8 and 11, q4wk and DXM was to be taken orally at a dose of 40 mg/day on D1, 8, 15 and 22, q4wk. A cycle was defined as 28 days, plus any additional days required for dosing delays due to any reason. Treatment cycles were repeated q4wk.
    id
    BG000
    title
    Experimental
measures
  1. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          0
        title
        <=18 years
      2. measurements
        1. group Id
          BG000
          value
          8
        title
        Between 18 and 65 years
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        >=65 years
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Age, Categorical
    unit Of Measure
    Participants
  2. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          lower Limit
          43
          upper Limit
          72
          value
          59
    dispersion Type
    FULL_RANGE
    param Type
    MEDIAN
    title
    Age, Continuous
    unit Of Measure
    years
  3. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        Female
      2. measurements
        1. group Id
          BG000
          value
          5
        title
        Male
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Sex: Female, Male
    unit Of Measure
    Participants
  4. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
      title
      White
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Other
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Race/Ethnicity, Customized
    unit Of Measure
    Participants
  5. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          4
      title
      Italy
    2. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      France
    3. categories
      1. measurements
        1. group Id
          BG000
          value
          3
      title
      Spain
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Region of Enrollment
    unit Of Measure
    Participants
  6. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          5
        title
        PS 0
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        PS 1
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        PS 2
    description
    ECOG PS, Eastern Cooperative Oncology Group performance status PS 0 Fully active able to carry on all pre-disease performance without restriction PS 1 Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature PS 2 Ambulatory and capable of all selfcare but unable to carry out any work activities up and about more than 50% of waking hours PS 3 Capable of only limited selfcare confined to bed or chair more than 50% of waking hours PS 4 Completely disabled cannot carry on any selfcare; totally confined to bed or chair PS 5 Dead
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ECOG PS
    unit Of Measure
    Participants
  7. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        Secretory IgA
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Secretory IgG
      3. measurements
        1. group Id
          BG000
          value
          2
        title
        Secretory Kappa light-chain disease
      4. measurements
        1. group Id
          BG000
          value
          2
        title
        Secretory Lambda light-chain disease
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Multiple myeloma type at diagnosis
    unit Of Measure
    Participants
  8. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        IIA
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        IIIA
      3. measurements
        1. group Id
          BG000
          value
          1
        title
        IIIB
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Missing
    description
    4 patients had missing data in stage and sub-classification Stage I: All of the following: Hemoglobin\>10 g/dl,Serum calcium\<10.5 mg/dL, normal bone structure,IgG\<5 g/dL; IgA\<3 g/dL, Urine light chain M-component\<4 g/24h Stage II:Fitting neither Stage I nor Stage III Stage III: One or more of the following: Hemoglobin\<8.5 g/dL, Serum calcium\>12 mg/dL,Advanced lytic bone lesions,IgG\>7 g/dL; IgA\> 5 g/dL,Urine light chain M-component\>12 g/24h Subclassification: A, serum creatinine\<2.0 mg/dL;B, serum creatinine\>2.0 mg/dL
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Durie-Salmon stage and subclassification at diagnosis
    unit Of Measure
    Participants
  9. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          1
        title
        ISS I
      2. measurements
        1. group Id
          BG000
          value
          1
        title
        ISS II
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        ISS III
      4. measurements
        1. group Id
          BG000
          value
          4
        title
        Not done
    description
    ISS, International Staging System ISS stage I was defined as serum β2-microglobulin level less than 3.5 mg/L and serum albumin level ≥ 3.5 g/dL. ISS stage II included all patients with neither stage I nor stage III disease. ISS stage III was defined as serum β2-microglobulin level ≥ 5.5 mg/L, irrespective of serum albumin level
    param Type
    COUNT_OF_PARTICIPANTS
    title
    ISS stage at diagnosis
    unit Of Measure
    Participants
  10. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          3
        title
        Stage II
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Stage III
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Non available genetic results
    description
    R-ISS, Revised International Staging System Stage I: Serum β2 microglobulin\<3.5 mg/l; Serum albumin≥3.5 g/dl;Standard-risk chromosomal abnormalities (CA);Normal LDH Stage II: Not R-ISS stage I or III Stage III: Serum β2 microglobulin≥5.5 mg/L and either High-risk CA by FISH OR High LDH
    param Type
    COUNT_OF_PARTICIPANTS
    title
    R-ISS stage at study entry
    unit Of Measure
    Participants
  11. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          2
        title
        High risk
      2. measurements
        1. group Id
          BG000
          value
          4
        title
        Standard risk
      3. measurements
        1. group Id
          BG000
          value
          4
        title
        Non available genetic results
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Cytogenetic at study entry
    unit Of Measure
    Participants
  12. classes
    1. categories
      1. measurements
        1. group Id
          BG000
          value
          7
        title
        Primary Refractory
      2. measurements
        1. group Id
          BG000
          value
          3
        title
        Relapsed and refractory
    description
    Total refractory MM included 2 categories of refractory: * Primary Refractory: disease that was non-responsive in patients who had never achieved a MR or better, with any therapy. It included patients who never achieved MR or better, in whom there was no significant change in M-protein and no evidence of clinical progression, as well as primary, refractory PD where patients met criteria for true PD. * Relapsed and refractory: disease that was non-responsive while on salvage therapy, or progressed within 60 days of the last therapy in patients who had achieved MR or better at some point
    param Type
    COUNT_OF_PARTICIPANTS
    title
    Disease status with respect to last prior therapy
    unit Of Measure
    Participants

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Preserved source evidence · Not medical advice