Participant flow

Phase III Study of Lenalidomide and Dexamethasone With or Without Elotuzumab to Treat Relapsed or Refractory Multiple Myeloma · Source last updated 2022-06-01

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

groups

1. description

   Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (Oral): On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug Dexamethasone (IV): On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1\&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug

   id

   FG000

   title

   Lenalidomide + Dexamethasone + Elotuzumab

2. description

   Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug

   id

   FG001

   title

   Lenalidomide + Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant no longer meets study criteria

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         7

      type

      Participant withdrew consent

   3. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Adverse event unrelated to study drug

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         321

      2. group Id

         FG001

         num Subjects

         325

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         319

      2. group Id

         FG001

         num Subjects

         316

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         9

      type

      NOT COMPLETED

   title

   Randomized Participants

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         185

      2. group Id

         FG001

         num Subjects

         185

      type

      Disease progression

   2. reasons

      1. group Id

         FG000

         num Subjects

         39

      2. group Id

         FG001

         num Subjects

         45

      type

      Study drug toxicity

   3. reasons

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         37

      type

      Adverse event unrelated to study drug

   4. reasons

      1. group Id

         FG000

         num Subjects

         28

      2. group Id

         FG001

         num Subjects

         18

      type

      Participants request to discontinue study treatment

   5. reasons

      1. group Id

         FG000

         num Subjects

         13

      2. group Id

         FG001

         num Subjects

         4

      type

      Administrative reason by sponsor

   6. reasons

      1. group Id

         FG000

         num Subjects

         14

      2. group Id

         FG001

         num Subjects

         14

      type

      Other reasons

   7. reasons

      1. group Id

         FG000

         num Subjects

         6

      2. group Id

         FG001

         num Subjects

         11

      type

      Participant withdrew consent

   8. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Death

   9. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         1

      type

      Participant no longer meets study criteria

   10. reasons

       1. group Id

          FG000

          num Subjects

          0

       2. group Id

          FG001

          num Subjects

          1

       type

       Poor/non-compliance

   milestones

   1. achievements

      1. comment

         1 participant was randomized to treatment E-Ld but received treatment Ld

         group Id

         FG000

         num Subjects

         318

      2. comment

         1 participant was randomized to treatment E-Ld but received treatment Ld

         group Id

         FG001

         num Subjects

         317

      comment

      Participants treated

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      comment

      Participants still on treatment

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         318

      2. group Id

         FG001

         num Subjects

         317

      type

      NOT COMPLETED

   title

   Treated Participants

pre Assignment Details

646 participants were randomized and 635 were treated

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Preserved source evidence · Not medical advice