Participant flow

Ixazomib Rollover Study · Source last updated 2025-03-12

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

groups

1. description

   Participants received ixazomib capsule, orally, at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, meet other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 7 years whichever was sooner.

   id

   FG000

   title

   Ixazomib Monotherapy

2. description

   Participants received combination therapy with ixazomib capsule, orally and another medication(s) (1 or more of the anticancer agents dexamethasone, lenalidomide or cyclophosphamide) at same dose and schedule as they were receiving in the parent study until disease progression, clinical deterioration in the investigator's judgment, experienced an unacceptable toxicity, withdrew consent, pursued an alternative therapy, met other study-specified reasons for discontinuation of study drug, or until the participant was transitioned to ixazomib through commercial channels, including reimbursement for the participant's indication, or up to a maximum of 6.5 years whichever was sooner.

   id

   FG001

   title

   Ixazomib Combination Therapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         4

      2. group Id

         FG001

         num Subjects

         1

      type

      Site Terminated by Sponsor

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         0

      type

      Adverse Event

   4. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         8

      type

      Progressive Disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Clinical Deterioration

   6. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   7. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Reason Not Specified

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         9

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         23

      2. group Id

         FG001

         num Subjects

         9

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants who had previously received and tolerated treatment in ixazomib parent studies (C16003 \[NCT00932698\], C16005 \[NCT01217957\], C16006 \[NCT01335685\],C16007 \[NCT01318902\],C16008 \[NCT01383928\],C16010 Global \[NCT01564537\],C16011 \[NCT01659658\],C16013 \[NCT01645930\],C16014 Global \[NCT01850524\] and Korean Continuation,C16017 \[NCT01939899\],C16020 \[NCT02046070\],C16029 \[NCT03170882\], or C16047 \[NCT03439293\]), and in investigator's opinion could benefit from continued therapy were enrolled.

recruitment Details

Participants took part in the study at various investigative sites globally from 16 December 2016 to 03 July 2024.

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Preserved source evidence · Not medical advice