Participant flow

Lenalidomide and Dexamethasone With/Without Stem Cell Transplant in Patients With Multiple Myeloma · Source last updated 2020-02-05

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

groups

1. description

   Subjects will receive the current standard of care treatment. Lenalidomide and dexamethasone for four 28-day cycles followed by stem cell collection and autologous peripheral blood stem cell transplant. After 90 days, start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Autologous peripheral blood stem cell transplant: Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0. Lenalidomide: Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle. Dexamethasone: Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle. Stem cell collection: Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is \>2500 x 109 cells/liter; platelet count is \>20 x 103/mm3. Melphalan: Subjects undergoing autologous peripheral blood stem cell transplant will receive

   id

   FG000

   title

   Arm A: Low-dose Dexamethasone + Stem Cell Transplantation

2. description

   Subjects will receive the new treatment that will be compared with the standard of care. Lenalidomide and dexamethasone for eight 28-day cycles. After four cycles your stem cells will be collected (stem cell collection). After an additional four cycles of lenalidomide (a total of 8 cycles), start the maintenance phase (lenalidomide days 1-21 every 28 days for two years or until your disease progresses). Lenalidomide: Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle. Dexamethasone: Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle. Stem cell collection: Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is \>2500 x 109 cells/liter; platelet count is \>20 x 103/mm3. Cyclophosphamide: Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously. Mesna: Mesna will be provided with the cyclophosphamide.

   id

   FG001

   title

   Arm B: Low-dose Dexamethasone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Death

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Never started treatment

   3. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         0

      type

      Non-compliant

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         31

      2. group Id

         FG001

         num Subjects

         29

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         29

      2. group Id

         FG001

         num Subjects

         28

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         1

      type

      NOT COMPLETED

   title

   Overall Study

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

Preserved source evidence · Not medical advice