Participant flow

Lenalidomide and High Dose Melphalan Followed by Autologous Stem Cell Transplant in Multiple Myeloma · Source last updated 2019-10-22

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

groups

1. description

   All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 50 mg given daily day -7 to day +2

   id

   FG000

   title

   Phase I, Dose Level 1

2. description

   All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 75 mg given daily day -7 to day +2

   id

   FG001

   title

   Phase I, Dose Level 2

3. description

   All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 100 mg given daily day -7 to day +2

   id

   FG002

   title

   Phase I, Dose Level 3

4. description

   All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2

   id

   FG003

   title

   Phase I, Dose Level 4

5. description

   All patients will receive Melphalan 100 mg/m2 intravenously day -2 and day -1 and Lenalidomide 150 mg given daily day -7 to day +2

   id

   FG004

   title

   Phase II

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         4

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      type

      Death

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         12

      type

      Disease Progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         3

      type

      Withdrawal by Subject

   5. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         2

      5. group Id

         FG004

         num Subjects

         10

      type

      Physician Decision

   6. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      3. group Id

         FG002

         num Subjects

         1

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      type

      Alternative Therapy

   7. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         1

      type

      Off Trt for other complicating disease

   8. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         0

      5. group Id

         FG004

         num Subjects

         2

      type

      Noncompliance

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         6

      5. group Id

         FG004

         num Subjects

         44

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         0

      3. group Id

         FG002

         num Subjects

         0

      4. group Id

         FG003

         num Subjects

         1

      5. group Id

         FG004

         num Subjects

         10

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         4

      3. group Id

         FG002

         num Subjects

         3

      4. group Id

         FG003

         num Subjects

         5

      5. group Id

         FG004

         num Subjects

         34

      type

      NOT COMPLETED

   title

   Overall Study

recruitment Details

This protocol was based on enrolling up to 16 patients phase I and up to 46 patients in phase II. The study enrolled 60 patients with 16 in phase I and 44 in phase II.

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Preserved source evidence · Not medical advice