Participant flow

Lenalidomide/Bortezomib/Dexamethasone & CNTO 328 in Transplant Eligible Newly Diagnosed Multiple Myeloma (MM) · Source last updated 2015-06-19

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

groups

1. description

   Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m\^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.

   id

   FG000

   title

   Siltuximab + Bortezomib + Lenalidomide

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         11

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         8

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Of the fourteen participant enrolled, three were screen failures and not enrolled on the study.

recruitment Details

Recruitment Period: May 10, 2012 to February 08, 2013. All recruitment done at The University of Texas MD Anderson Cancer Center.

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Preserved source evidence · Not medical advice