Baseline characteristics

Study of Ibrutinib in Combination With Bortezomib and Dexamethasone in Subjects With Relapsed/Relapsed and Refractory Multiple Myeloma · Source last updated 2020-03-16

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

      74

   units

   Participants

groups

1. description

   Ibrutinib (I): I 840 mg orally, once daily continuously starting day 1 of Cycle (C) 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation Bortezomib (B): C 1-8: (21-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 4, 8, and 11 of each C C 9-12: (42-day C): B 1.3 mg/m\^2 sub-cutaneously on days 1, 8, 22 and 29 of each C Dexamethasone(D): C 1-8: (21-day C): D 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each C C 9-12: (42-day C): D 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each C C 13+ (28-day C): D 40 mg orally once weekly Dose adjustment of D to 10 mg on days specified during C 1-12 and 20 mg weekly during C 13+ is recommended for subjects \>75 years of age. Following implementation of Protocol Amendment 4, D administration was reduced to Days 1, 4, 8 and 11 during each 21-day C (C 1-8) and on Days 1, 8, 22 and 29 on each 42-day C (C 9-12) and unchanged thereafter.

   id

   BG000

   title

   Ibrutinib+ Bortezomib+ Dexamethasone

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            29

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            45

         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

            spread

            10.14

            value

            65.9

   dispersion Type

   STANDARD_DEVIATION

   param Type

   MEAN

   title

   Age, Continuous

   unit Of Measure

   years

3. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            39

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            35

         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

            2

         title

         Hispanic or Latino

      2. measurements

         1. group Id

            BG000

            value

            68

         title

         Not Hispanic or Latino

      3. measurements

         1. group Id

            BG000

            value

            4

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Ethnicity (NIH/OMB)

   unit Of Measure

   Participants

5. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         American Indian or Alaska Native

      2. measurements

         1. group Id

            BG000

            value

            0

         title

         Asian

      3. measurements

         1. group Id

            BG000

            value

            0

         title

         Native Hawaiian or Other Pacific Islander

      4. measurements

         1. group Id

            BG000

            value

            0

         title

         Black or African American

      5. measurements

         1. group Id

            BG000

            value

            71

         title

         White

      6. measurements

         1. group Id

            BG000

            value

            0

         title

         More than one race

      7. measurements

         1. group Id

            BG000

            value

            3

         title

         Unknown or Not Reported

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Race (NIH/OMB)

   unit Of Measure

   Participants

6. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            11

      title

      Greece

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            13

      title

      Turkey

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            23

      title

      Czechia

   4. categories

      1. measurements

         1. group Id

            BG000

            value

            10

      title

      Italy

   5. categories

      1. measurements

         1. group Id

            BG000

            value

            1

      title

      Germany

   6. categories

      1. measurements

         1. group Id

            BG000

            value

            16

      title

      Spain

   param Type

   NUMBER

   title

   Region of Enrollment

   unit Of Measure

   participants

population Description

All participant received: see description on Arm/Group description.

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Preserved source evidence · Not medical advice