Participant flow

Velcade + Cyclophosphamide in Newly Diagnosed Multiple Myeloma · Source last updated 2017-05-31

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

groups

1. description

   INDUCTION (28-day cycles for 8 cycles): * VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15 * Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15 * Dexamethasone 40 mg PO days 1,8 and 15 MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death): * Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21 * Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15 Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles \[10,12,14, etc.\]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until

   id

   FG000

   title

   Velcade, Cyclophosphamide, Revlimid

periods

1. milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         16

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         14

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

17 subjects consented to the study. 1 subject was a screen failure.

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Preserved source evidence · Not medical advice