Participant flow

A Study to Evaluate 3 Dose Schedules of Daratumumab in Participants With Smoldering Multiple Myeloma · Source last updated 2026-04-23

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

groups

1. description

   Participants received daratumumab 16 milligrams per kilogram (mg/kg) as intravenous (IV) infusion once every week (Q1W) (Days 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, every other week (Q2W) (Days 1, 15, 29 and 43) in Cycle 2 and 3, every 4 weeks (Q4W) (Days 1 and 29) in Cycle 4 to 7, and on Day 1 from Cycle 8 to 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion every 8 weeks (Q8W), after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg subcutaneous (SC) Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).

   id

   FG000

   title

   Arm A (Long Intense)

2. description

   Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and Q8W after Cycle 20. Each treatment cycle was of 8 weeks. After Cycle 20, per investigator's discretion, participants either entered into extension phase or completed end of treatment visit 4 weeks after last dose. In extension phase, participants continued to receive daratumumab 16 mg/kg as IV infusion Q8W after end of Cycle 20 up to 91.6 months, and then completed end of treatment visit 4 weeks after last dose. After protocol amendment 5, participants in extension phase optionally switched to daratumumab 1800 mg SC Q8W per investigator's discretion. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal/study end, whichever occurred first (up to 7.89 years).

   id

   FG001

   title

   Arm B (Intermediate)

3. description

   Participants received daratumumab 16 mg/kg as IV infusion Q1W (Day 1, 8, 15, 22, 29, 36, 43 and 50) in Cycle 1 alone. Treatment cycle was of 8 weeks. After Cycle 1, participants completed the end of treatment visit 4 weeks after last dose and were followed up for safety until death, lost to follow up, consent withdrawal, or study end, whichever occurred first (up to 7.89 years).

   id

   FG002

   title

   Arm C (Short Intense)

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         9

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      type

      Other

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         5

      3. group Id

         FG002

         num Subjects

         4

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         31

      3. group Id

         FG002

         num Subjects

         27

      type

      End of data collection

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         41

      3. group Id

         FG002

         num Subjects

         41

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         21

      2. group Id

         FG001

         num Subjects

         15

      3. group Id

         FG002

         num Subjects

         0

      type

      Participants Who Entered Extension Phase

   3. achievements

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         0

      type

      Participants Switched: Daratumumab IV to SC

   4. achievements

      1. group Id

         FG000

         num Subjects

         41

      2. group Id

         FG001

         num Subjects

         41

      3. group Id

         FG002

         num Subjects

         40

      type

      Treated

   5. achievements

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         41

      3. group Id

         FG002

         num Subjects

         41

      type

      NOT COMPLETED

   title

   Overall Study

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Preserved source evidence · Not medical advice