Participant flow

Study of Bortezomib,Lenalidomide,Dexamethasone & Elotuzumab in Newly Diagnosed MM · Source last updated 2024-10-01

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

groups

1. description

   Participants will receive therapy with the combination of lenalidomide, bortezomib, and dexamethasone and elotuzumab (E-RVD). Induction cycles (1 to 8) are 21-day cycles. * Elotuzumab will be administered by intravenous (IV) infusion * Bortezomib as a subcutaneous injection * Lenalidomide single daily oral dose * Dexamethasone as oral tablets and IV infusion * Stem cell mobilization will be performed for all subjects at the end of Cycle 4. Subjects who attain at least a partial response (PR) may elect to stop E-RVD at the end of Induction Cycle 4 and proceed to autologous SCT. Subjects who do not proceed to SCT may receive 8 cycles of induction therapy. \- The maintenance schedule (28 days) will start after 8 cycles of induction regimen for subjects not proceeding with SCT, or after recovery from SCT for subjects proceeding with it. Maintenance therapy with E-RVD will be administered to all patients, with the specific maintenance regimen determined by risk category. Lenalidomide Elotuzumab Bortezomib Dexamethasone Stem Cell Mobilization

   id

   FG000

   title

   Elotuzumab, Lenalidomide, Bortezomib, and Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Other

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Didn't meet criteria for maintenance therapy

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         40

      type

      STARTED

   2. achievements

      1. comment

         Of the 40 patients comprising the safety population, 34 patients completed 4 cycles (cycles 1-4) of induction therapy.

         group Id

         FG000

         num Subjects

         34

      type

      Induction Therapy Cycles 1-4

   3. achievements

      1. comment

         Of the 40 patients comprising the safety population, 12 patients completed 4 additional cycles (cycles 5-8) of induction therapy.

         group Id

         FG000

         num Subjects

         12

      type

      Induction Therapy Cycles 5-8

   4. achievements

      1. comment

         Of the 40 patients comprising the safety population, 19 patients received autologous stem cell transplant (ASCT) at the end of Induction cycle 4.

         group Id

         FG000

         num Subjects

         19

      type

      Autologous Stem Cell Transplant

   5. achievements

      1. group Id

         FG000

         num Subjects

         29

      type

      COMPLETED

   6. achievements

      1. group Id

         FG000

         num Subjects

         11

      type

      NOT COMPLETED

   title

   Induction Period

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         4

      type

      Withdrawal by Subject

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Disease Progression

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Patient Non-compliance

   6. reasons

      1. group Id

         FG000

         num Subjects

         16

      type

      Still on maintenance

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         29

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         29

      type

      NOT COMPLETED

   title

   Maintenance Period

recruitment Details

Participants were enrolled from May 2015 to April 2016.

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Preserved source evidence · Not medical advice