Participant flow

A Study to Evaluate the Efficacy and Safety of Daratumumab in Combination With Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared to CyBorD Alone in Newly Diagnosed Systemic Amyloid Light-chain (AL) Amyloidosis · Source last updated 2025-11-26

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

groups

1. description

   Participants received the combination therapy during Run-in phase starting with 20 milligrams (mg) dexamethasone as premedication followed by daratumumab 1800 mg on Day 1 Cycle 1, then cyclophosphamide 300 milligram per meter square (mg/m\^2) orally or intravenous (IV) maximum weekly dose 500 mg, followed by bortezomib 1.3 mg/m\^2 subcutaneous (SC) injection once every week and dexamethasone remaining 20 mg post daratumumab dosing for up to 1 cycle (28 Days) to assess the safety before randomizing participants in CyBorD or daratumumab plus CyBorD arms. However, participants also continued daratumumab plus CyBorD for up to 6 cycles and then daratumumab monotherapy for up to 24 months from the start of treatment. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).

   id

   FG000

   title

   Run-In: Daratumumab Plus CyBorD

2. description

   Participants received dexamethasone (40 mg weekly dose)starting from cycle 1 day1 in every 28-day cycle followed by cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg and then bortezomib 1.3 mg/m\^2 SC injection once weekly up to 7.33 months. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).

   id

   FG001

   title

   CyBorD

3. description

   Participants received combination therapy for six cycles of 28 days each, daratumumab 1800 mg SC weekly starting from cycles 1 day 1 and cycle 2, every 2 weeks in cycles 3 through 6, dexamethasone 40 mg weekly (on days of daratumumab dosing, dexamethasone was split, 20 mg as premedication and 20 mg as post daratumumab dosing), cyclophosphamide 300 mg/m\^2 orally or IV maximum weekly dose 500 mg, bortezomib 1.3 mg/m\^2 SC injection once weekly. After 6 cycles, participants continued to receive daratumumab SC monotherapy until disease progression, start of subsequent therapy or up to 26.71 months from the first dose of study treatment. All cycles were of 28 days. After completion of treatment phase participants entered into the post treatment observation phase and were continued with disease evaluations every 8 weeks post last dose up to disease progression (up to 6.5 years). Participants then entered into long term follow up phase and were followed up for survival every 16 weeks (up to 7.1 years).

   id

   FG002

   title

   Daratumumab Plus CyBorD

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      2. group Id

         FG001

         num Subjects

         65

      3. group Id

         FG002

         num Subjects

         47

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         6

      3. group Id

         FG002

         num Subjects

         0

      type

      Lost to Follow-up

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         23

      3. group Id

         FG002

         num Subjects

         8

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         99

      3. group Id

         FG002

         num Subjects

         140

      type

      Sponsor's Decision

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         193

      3. group Id

         FG002

         num Subjects

         195

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         188

      3. group Id

         FG002

         num Subjects

         193

      type

      Treated

   3. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         193

      3. group Id

         FG002

         num Subjects

         195

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with newly diagnosed Amyloid Light-chain (AL) amyloidosis with measurable disease and at least one organ involvement, and Mayo cardiac stage I - IIIA, who had not received prior therapy for AL amyloidosis or multiple myeloma were enrolled.

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Preserved source evidence · Not medical advice