Participant flow

A Study of Subcutaneous Versus (vs.) Intravenous Administration of Daratumumab in Participants With Relapsed or Refractory Multiple Myeloma · Source last updated 2025-04-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

groups

1. description

   Participants received daratumumab intravenous infusion (Dara IV) 16 milligrams per kilogram (mg/kg) once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.

   id

   FG000

   title

   Daratumumab IV

2. description

   Participants received daratumumab 1800 mg subcutaneous injection (Dara SC) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 Units per milliliter (U/mL), once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks thereafter until disease progression, unacceptable toxicity, withdrawal of consent, the investigator decides to stop treatment, or the start of subsequent anticancer therapy. The duration for each cycle was 28 days.

   id

   FG001

   title

   Daratumumab SC

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         129

      2. group Id

         FG001

         num Subjects

         124

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         4

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         10

      2. group Id

         FG001

         num Subjects

         10

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         118

      2. group Id

         FG001

         num Subjects

         125

      type

      Other

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         259

      2. group Id

         FG001

         num Subjects

         263

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         258

      2. group Id

         FG001

         num Subjects

         260

      type

      Treated (Safety Analysis Set)

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         259

      2. group Id

         FG001

         num Subjects

         263

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice