Participant flow

Velcade,Thalidomide, and Dexamethasone Versus Velcade and Dexamethasone Versus Velcade, Melphalan, and Prednisone · Source last updated 2014-05-01

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

groups

1. description

   Participants received bortezomib (Velcade) 1.3 mg/m\^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

   id

   FG000

   title

   Bortezomib and Dexamethasone

2. description

   Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

   id

   FG001

   title

   Bortezomib, Thalidomide, and Dexamethasone

3. description

   Participants received bortezomib 1.3 mg/m\^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m\^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m\^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/\^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).

   id

   FG002

   title

   Bortezomib, Melphalan and Prednisone

periods

1. drop Withdraws

   1. reasons

      1. group Id

         FG000

         num Subjects

         58

      2. group Id

         FG001

         num Subjects

         67

      3. group Id

         FG002

         num Subjects

         65

      type

      Adverse Event

   2. reasons

      1. group Id

         FG000

         num Subjects

         1

      2. group Id

         FG001

         num Subjects

         2

      3. group Id

         FG002

         num Subjects

         0

      type

      Protocol Violation

   3. reasons

      1. group Id

         FG000

         num Subjects

         7

      2. group Id

         FG001

         num Subjects

         7

      3. group Id

         FG002

         num Subjects

         8

      type

      Lack ofEfficacy / Physician Decision

   4. reasons

      1. group Id

         FG000

         num Subjects

         20

      2. group Id

         FG001

         num Subjects

         10

      3. group Id

         FG002

         num Subjects

         13

      type

      Progressive Disease

   5. reasons

      1. group Id

         FG000

         num Subjects

         18

      2. group Id

         FG001

         num Subjects

         14

      3. group Id

         FG002

         num Subjects

         11

      type

      Patient declined further treatment

   6. reasons

      1. group Id

         FG000

         num Subjects

         11

      2. group Id

         FG001

         num Subjects

         16

      3. group Id

         FG002

         num Subjects

         13

      type

      Other

   7. reasons

      1. group Id

         FG000

         num Subjects

         3

      2. group Id

         FG001

         num Subjects

         9

      3. group Id

         FG002

         num Subjects

         4

      type

      Did not Receive Study Treatment

   milestones

   1. achievements

      1. group Id

         FG000

         num Subjects

         168

      2. group Id

         FG001

         num Subjects

         167

      3. group Id

         FG002

         num Subjects

         167

      type

      STARTED

   2. achievements

      1. group Id

         FG000

         num Subjects

         165

      2. group Id

         FG001

         num Subjects

         158

      3. group Id

         FG002

         num Subjects

         163

      type

      Treated (Safety Population)

   3. achievements

      1. group Id

         FG000

         num Subjects

         82

      2. group Id

         FG001

         num Subjects

         60

      3. group Id

         FG002

         num Subjects

         69

      type

      Completed 8 Treatment Cycles

   4. achievements

      1. comment

         Completed is defined as having completed 13 treatment cycles.

         group Id

         FG000

         num Subjects

         50

      2. comment

         Completed is defined as having completed 13 treatment cycles.

         group Id

         FG001

         num Subjects

         42

      3. comment

         Completed is defined as having completed 13 treatment cycles.

         group Id

         FG002

         num Subjects

         53

      type

      COMPLETED

   5. achievements

      1. group Id

         FG000

         num Subjects

         118

      2. group Id

         FG001

         num Subjects

         125

      3. group Id

         FG002

         num Subjects

         114

      type

      NOT COMPLETED

   title

   Overall Study

pre Assignment Details

Participants with previously untreated multiple myeloma were randomized in a 1:1:1 ratio to one of three treatment groups: VD: Velcade (bortezomib) and dexamethasone; VTD: Velcade, thalidomide, and dexamethasone; VMP: Velcade, melphalan, and prednisone.

recruitment Details

Participants took part in the study at 158 investigative sites in the United States from 26 June 2007 to 28 March 2013

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Preserved source evidence · Not medical advice