Baseline characteristics

Study to Evaluate the Combination of Bendamustine, Bortezomib and Dexamethasone (BBD) in the First-Line Treatment of Patients With Multiple Myeloma Who Are Not Candidates for High Dose Chemotherapy · Source last updated 2017-05-03

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

      18

   2. group Id

      BG001

      value

      41

   3. group Id

      BG002

      value

      59

   units

   Participants

groups

1. description

   Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy. Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4

   id

   BG000

   title

   Original BBD Regimen

2. description

   Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion. Treatment: Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16 Maintenance: Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15

   id

   BG001

   title

   Modified BBD Regimen

3. description

   Total of all reporting groups

   id

   BG002

   title

   Total

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            lower Limit

            55

            upper Limit

            81

            value

            75

         2. group Id

            BG001

            lower Limit

            45

            upper Limit

            89

            value

            75

         3. group Id

            BG002

            lower Limit

            45

            upper Limit

            89

            value

            75

   dispersion Type

   FULL_RANGE

   param Type

   MEDIAN

   title

   Age, Continuous

   unit Of Measure

   years

2. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            5

         2. group Id

            BG001

            value

            14

         3. group Id

            BG002

            value

            19

         title

         female

      2. measurements

         1. group Id

            BG000

            value

            13

         2. group Id

            BG001

            value

            26

         3. group Id

            BG002

            value

            39

         title

         male

      3. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            1

         title

         unknown

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Sex/Gender, Customized

   unit Of Measure

   Participants

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            1

      title

      American Indian/Alaskan Native

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            1

         2. group Id

            BG001

            value

            0

         3. group Id

            BG002

            value

            1

      title

      Asian

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            3

         2. group Id

            BG001

            value

            10

         3. group Id

            BG002

            value

            13

      title

      Black/African American

   4. categories

      1. measurements

         1. group Id

            BG000

            value

            14

         2. group Id

            BG001

            value

            27

         3. group Id

            BG002

            value

            41

      title

      Caucasian

   5. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            2

         3. group Id

            BG002

            value

            2

      title

      White

   6. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         2. group Id

            BG001

            value

            1

         3. group Id

            BG002

            value

            1

      title

      Unknown

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race/Ethnicity, Customized

   unit Of Measure

   Participants

4. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            18

         2. group Id

            BG001

            value

            41

         3. group Id

            BG002

            value

            59

      title

      United States

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

population Description

All patients enrolled in either the original treatment regimen or the modified treatment regimen.

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Preserved source evidence · Not medical advice