Participant flow

Study of Oral Ixazomib Maintenance Therapy After Initial Therapy in Participants With Newly Diagnosed Multiple Myeloma Not Treated With Stem Cell Transplantation (SCT) · Source last updated 2025-03-21

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

groups

1. description

   Participants received ixazomib 3 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 1 through 4, during which if the participants tolerated the initial dose, the dose was escalated to ixazomib 4 mg, capsules, orally, once on Days 1, 8, and 15 for Cycles 5 through 26, or until documented progressive disease (PD) or intolerable toxicity, whichever occurred first (cycle length=28 days).

   id

   FG000

   title

   Ixazomib

2. description

   Participants received ixazomib placebo-matching capsules, orally, once on Days 1, 8, and 15 of each cycle until Protocol Amendment 08 was implemented (cycle length=28 days).

   id

   FG001

   title

   Placebo

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Discontinued to Switch to Ixazomib

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      Reason not Specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         4

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      comment

      Placebo Safety Population included all participants who received at least 1 dose of placebo.

      type

      Placebo Safety Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         4

      type

      NOT COMPLETED

   title

   Treatment Prior to Amendment 08

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         16

      2. group Id

         FG001

         num Subjects

         0

      type

      Reason not Specified

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Lost to Follow-up

   milestones

   1. achievements

      1. comment

         6 participants (initially receiving ixazomib, before Protocol Amendment 08 was implemented) continued to receive ixazomib after implementation of Amendment 08 and 2 participants who received placebo before Amendment 08 switched to ixazomib after the implementation.

         group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         0

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         33

      2. group Id

         FG001

         num Subjects

         0

      comment

      Efficacy Population included all participants who received ixazomib treatment for the duration of their study participation. Participants who were randomized to the placebo arm and crossed over to the ixazomib arm upon implementation of Amendment 08 were not included.

      type

      Efficacy Population

   3. achievements

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         0

      comment

      Ixazomib Safety Population included all participants who received at least 1 dose of ixazomib.

      type

      Ixazomib Safety Population

   4. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         35

      2. group Id

         FG001

         num Subjects

         0

      type

      NOT COMPLETED

   title

   Treatment Post Amendment 08

pre Assignment Details

Of the 31 participants who newly enrolled in this study, 10 (4 randomized to placebo and 6 to ixazomib) were enrolled before the implementation of Protocol Amendment 08, and 21 under the amendment, with all 21 receiving ixazomib as the study design was changed to a single-arm study. After Amendment 08, 2 of the 4 participants who were initially randomized to placebo crossed over to the ixazomib arm. As per planned analysis, these 4 participants were not included in the Efficacy Population.

recruitment Details

A total of 37 participants (31 enrolled in this study and 6 rolled over from study C16021\[NCT02312258\]) with a diagnosis of newly diagnosed multiple myeloma (NDMM) not treated with stem cell transplantation (SCT) took part in the study at investigative sites in China from 24 January 2019 to 06 December 2023.

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

Preserved source evidence · Not medical advice