Participant flow

Elotuzumab, Lenalidomide and Dexamethasone in Treatment of Transplant-Eligible Newly Diagnosed Multiple Myeloma Patients · Source last updated 2023-12-05

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

groups

1. description

   INDUCTION: Cycles 1-2: elotuzumab 10mg/kg IV days 1, 8, 15, 22; lenalidomide (len) 25mg orally (PO), once daily (QD) on days 1-21; dexamethasone (dex) 28 mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1, 8, 15, 22. Cycles 3-4: elotuzumab 10mg/kg IV days 1 and 15; len 25mg PO QD days 1-21; dex 8mg PO (3-24 hrs before elotuzumab IV) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. CONSOLIDATION: Four 28-day cycles: elotuzumab 10mg/kg IV days 1 and 15; len 15mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes before elotuzumab) days 1 and 15; dex 40mg PO days 8 and 22. MAINTENANCE: After completing consolidation therapy patients without progressive disease will receive, for up to 24 months, 28-day cycles of elotuzumab 20mg/kg IV day 1; len 10mg +/- 5mg PO QD days 1-21; dex 28mg PO (3-24 hrs before elotuzumab) and 8mg IV (45-90 minutes prior to elotuzumab) day 1. elotuzumab: Given intravenously (IV) Lenalidomide: Given by IV Dexamethasone: Given orally (PO) or by IV autologous stem cell transplantation

   id

   FG000

   title

   ERd Therapy

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Withdrawal by Subject

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Progressive disease

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Lost to Follow-up

   5. reasons

      1. group Id

         FG000

         num Subjects

         9

      type

      Death

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         52

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         35

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         17

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

One participant withdrew consent before the study treatment assignment.

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

Preserved source evidence · Not medical advice