Baseline characteristics

Efficacy of Daratumumab in Patients With Relapsed/Refractory Myeloma With Renal Impairment · Source last updated 2024-03-29

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

      38

   units

   Participants

groups

1. description

   Daratumumab: Daratumumab was given at a dose of 16 mg/kg administered as an intravenous (IV) infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Dexamethasone was administered according to the standard recommended dose of 40 mg (20 mg for patients\>75 years of age) orally once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle. Subjects received pre-infusion medications before infusions to mitigate potential infused-related reactions (IRRs). Dexamethasone: Dexamethasone was administered at 40 mg (20 mg for patients \>75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.

   id

   BG000

   title

   Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)

measures

1. classes

   1. categories

      1. measurements

         1. group Id

            BG000

            value

            0

         title

         <=18 years

      2. measurements

         1. group Id

            BG000

            value

            10

         title

         Between 18 and 65 years

      3. measurements

         1. group Id

            BG000

            value

            28

         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

            11.2

            value

            69.6

   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

            29

         title

         Female

      2. measurements

         1. group Id

            BG000

            value

            9

         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

            32

      title

      Greek

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            4

      title

      Other European

   3. categories

      1. measurements

         1. group Id

            BG000

            value

            2

      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

            34

      title

      Greece

   2. categories

      1. measurements

         1. group Id

            BG000

            value

            4

      title

      Italy

   param Type

   COUNT_OF_PARTICIPANTS

   title

   Region of Enrollment

   unit Of Measure

   Participants

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

Preserved source evidence · Not medical advice