Participant flow

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.

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

   FG000

   title

   Single Arm Trial Receiving Daratumumab With Dexamethasone (DaraD)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         17

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      ICF withdrawal

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         38

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         15

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         23

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice