Participant flow

S0115, High-Dose Melphalan and Autologous Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma or Primary Systemic Amyloidosis · Source last updated 2018-08-09

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

groups

1. description

   MM Induction: dexamethasone 20mg/d PO Days 1-4, 9-12 and 17-20 every 35 days for 2 cycles and thalidomide 200 mg/d PO Days 1-70. Mobilization and SC Collection: MM, MM+AL, MM+LCD: cyclophosphamide 2.5 gm/m2 IV Day 1; mesna 800 mg/m2 IV Day 1 x 3 doses; G-CSF 10 mcg/kg/d SQ Day 2 through day prior to last leukapheresis. Amyloid or LCDD-Only: G-CSF 16 mcg/kg/d SQ Days 1-3 (continued daily until the day prior to the last day of stem cell collection). Conditioning/Transplant - Modified HighDose Melphalan (given for both transplants): melphalan 100 mg/m2/d IV over 20 mins Day -2; PBSC infusion \>/= 3.5 x 10\^6 CD34+ cells/kg IV Day 0. Maintenance (MM only): dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year, followed by dexamethasone 40 mg/d PO Days 1-4 every 28 days and thalidomide 100 mg/d PO daily - given for one year. filgrastim cyclophosphamide dexamethasone melphalan thalidomide peripheral blood

   id

   FG000

   title

   Treatment

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         7

      type

      Not protocol-specified

   2. reasons

      1. group Id

         FG000

         num Subjects

         6

      type

      Adverse Event

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Progression

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Patient Refusal

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Death

   milestones

   1. achievements

      1. comment

         104 patients were registered, 93 of whom were eligible and analyzable.

         group Id

         FG000

         num Subjects

         93

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         73

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         20

      type

      NOT COMPLETED

   title

   PBSCC or Induction/PBSCC

2. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         9

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         5

      type

      Not protocol-specified

   3. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Death

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Patient Refusal

   5. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Progression

   milestones

   1. achievements

      1. comment

         6 patients who completed PBSCC or Induction/PBSCC did not begin Transplant

         group Id

         FG000

         num Subjects

         67

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         46

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         21

      type

      NOT COMPLETED

   title

   Transplant

3. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         3

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Progression

   3. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      On treatment at time of analysis

   4. reasons

      1. group Id

         FG000

         num Subjects

         2

      type

      Not protocol-specified

   5. reasons

      1. group Id

         FG000

         num Subjects

         1

      type

      Death

   milestones

   1. achievements

      1. comment

         Only patients with High Risk MM or AL + MM were allowed to enroll to Maintenance treatment.

         group Id

         FG000

         num Subjects

         13

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         3

      type

      COMPLETED

   3. achievements

      1. group Id

         FG000

         num Subjects

         10

      type

      NOT COMPLETED

   title

   Maintenance

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

Preserved source evidence · Not medical advice