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NCT00492050 · FLOW

Participant flow

Bortezomib and Rituximab for Patients With Waldenstrom's Macroglobulinemia · Source last updated 2026-03-11

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

groups
  1. description
    Bortezomib 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily). Bortezomib: 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab: 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir: 500 mg orally daily (or acyclovir 200 mg orally twice daily)
    id
    FG000
    title
    Bortezomib + Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Unable to collect SCT
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Progressive Disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        37
      comment
      (Additonal cycle 3); Bortezomib 1.6 mg/m2, Rituximab 375 mg/m2 (1 additional cycle)
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      Inadequate Response to First Two Cycles
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      comment
      Rituximab 375 mg/m\^2, Cyclophosphamide 100 mg/m\^2, Doborubicine 9 mg/m\^2/day, dexamethasone 40 mg/day (2 cycles)
      type
      Inadequate Response to First 3 Cycles
    4. achievements
      1. group Id
        FG000
        num Subjects
        30
      comment
      \+ 1 cycle of 2CdA 3.0 mg/m2, cyclophosphamide 60 mg/m2, rituximab 375 mg/m2
      type
      If Adequate Response to First Two Cycles-participants Proceed to Stem Cell Collection
    5. achievements
      1. group Id
        FG000
        num Subjects
        28
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
46 Participants consented, 9 screen failures.
recruitment Details
Recruitment Period: August 2006- March 2013
Complete source fields
groups
  1. description
    Bortezomib 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir 500 mg orally daily (or acyclovir 200 mg orally twice daily). Bortezomib: 1.6 mg/m\^2 IV Weekly on Days 1, 8, 15 and 22. Rituximab: 375 mg/m\^2 IV on Day 8 and 22. Valacyclovir: 500 mg orally daily (or acyclovir 200 mg orally twice daily)
    id
    FG000
    title
    Bortezomib + Rituximab
periods
  1. drop Withdraws
    1. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Adverse Event
    2. reasons
      1. group Id
        FG000
        num Subjects
        1
      type
      Lack of Efficacy
    3. reasons
      1. group Id
        FG000
        num Subjects
        3
      type
      Withdrawal by Subject
    4. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Unable to collect SCT
    5. reasons
      1. group Id
        FG000
        num Subjects
        2
      type
      Progressive Disease
    milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        37
      comment
      (Additonal cycle 3); Bortezomib 1.6 mg/m2, Rituximab 375 mg/m2 (1 additional cycle)
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        25
      type
      Inadequate Response to First Two Cycles
    3. achievements
      1. group Id
        FG000
        num Subjects
        12
      comment
      Rituximab 375 mg/m\^2, Cyclophosphamide 100 mg/m\^2, Doborubicine 9 mg/m\^2/day, dexamethasone 40 mg/day (2 cycles)
      type
      Inadequate Response to First 3 Cycles
    4. achievements
      1. group Id
        FG000
        num Subjects
        30
      comment
      \+ 1 cycle of 2CdA 3.0 mg/m2, cyclophosphamide 60 mg/m2, rituximab 375 mg/m2
      type
      If Adequate Response to First Two Cycles-participants Proceed to Stem Cell Collection
    5. achievements
      1. group Id
        FG000
        num Subjects
        28
      type
      COMPLETED
    6. achievements
      1. group Id
        FG000
        num Subjects
        9
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
46 Participants consented, 9 screen failures.
recruitment Details
Recruitment Period: August 2006- March 2013

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Preserved source evidence · Not medical advice