Participant flow

Study of Melphalan and Topotecan (MT) Followed by Autologous Stem Cell Rescue in Patients With Multiple Myeloma. · Source last updated 2018-03-14

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

groups

1. description

   Participants 18 - 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0

   id

   FG000

   title

   Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue

2. description

   Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant. melphalan: (Days -4,-3,-2) 50 mg/m\^2/day IV over 30 minutes (total dose 150 mg/m\^2) topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m\^2; Level 2 - 30 mg/m\^2; Level 4 - 54 mg/m\^2; Level 5 - 72 mg/m\^2; Level 6 - 96 mg/m\^2; Level 7 - 127.8 mg/m\^2; Level 8 - 170.1 mg/m\^2 Phase II: Treatment at maximum tolerated dose (MTD) Autologous Stem Cell Rescue: Day 0

   id

   FG001

   title

   Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         8

      2. group Id

         FG001

         num Subjects

         9

      type

      Pre-transplant screen failure

   2. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         4

      type

      Denial of insurance coverage

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         2

      type

      Withdrawal by Subject

   4. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Inability to collect adequate stem cells

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         70

      2. group Id

         FG001

         num Subjects

         60

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         48

      2. group Id

         FG001

         num Subjects

         44

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         22

      2. group Id

         FG001

         num Subjects

         16

      type

      NOT COMPLETED

   title

   Phase I: Dose Escalation

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      denial of insurance coverage

   2. reasons

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         1

      type

      Withdrawal by Subject

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         78

      2. group Id

         FG001

         num Subjects

         42

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         38

      2. group Id

         FG001

         num Subjects

         34

      type

      Proceeded From Phase I to Phase II

   3. achievements

      1. group Id

         FG000

         num Subjects

         40

      2. group Id

         FG001

         num Subjects

         8

      type

      Enrolled During Phase II

   4. achievements

      1. group Id

         FG000

         num Subjects

         78

      2. group Id

         FG001

         num Subjects

         40

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         0

      2. group Id

         FG001

         num Subjects

         2

      type

      NOT COMPLETED

   title

   Phase II: Treatment at MTD

recruitment Details

Phase I: 129 (70 Group A and 60 Group B) participants were enrolled during the Phase I portion. Phase II: 48 (40 Group A and 8 Group B) participants were enrolled during the Phase II portion. Both Phases: 72 Phase I participants were still on study when Phase II began.

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

Preserved source evidence · Not medical advice