Participant flow

A Study of Subcutaneous Daratumumab Versus Active Monitoring in Participants With High-Risk Smoldering Multiple Myeloma · Source last updated 2026-06-08

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

groups

1. description

   Participants in the active monitoring group did not receive any study medication but underwent disease evaluations for every 12 weeks until disease progression (PD) as those randomized to receive daratumumab.

   id

   FG000

   title

   Arm A: Active Monitoring (ACTM)

2. description

   Participants received daratumumab 1800 milligrams (mg) co-formulated with recombinant human hyaluronidase (rHuPH20) 2000 units per milliliter (U/mL) as subcutaneous (SC) injection once every week (Q1W) (Days 1, 8, 15, and 22 of each week) in Cycles 1 and 2, every 2 weeks (Q2W) (Days 1 and 15) from Cycle 3 to Cycle 6, and thereafter every 4 weeks (Day 1) from Cycle 7 to Cycle 39, for a maximum of 36 months, or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment. In addition, disease evaluations were performed every 12 weeks until PD. Each treatment cycle was 28 days. After end of treatment, participants were followed up for safety until death, lost to follow up, consent withdrawal or study end, whichever occurred first (up to 8 years).

   id

   FG001

   title

   Arm B: Daratumumab SC

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         26

      2. group Id

         FG001

         num Subjects

         15

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         12

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Lost to Follow-up

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Randomized in error

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Randomized but not treated

   6. reasons

      1. group Id

         FG000

         num Subjects

         145

      2. group Id

         FG001

         num Subjects

         163

      type

      Ongoing followup

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Principal Investigator and participant decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         196

      2. group Id

         FG001

         num Subjects

         194

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         196

      2. group Id

         FG001

         num Subjects

         193

      type

      Treated

   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

         196

      2. group Id

         FG001

         num Subjects

         194

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Results are currently reported until the primary completion date (01 May 2024). Results of remaining duration will be posted upon study completion.

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice