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NCT01653418 · OUTCOME

Toxicity of V-BEAM

Phase II Study of V-BEAM Conditioning Regimen Prior to Second Autologous Stem Cell Transplantation · Source last updated 2014-10-15

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
30 days after end of treatment / Day +100

What was measured

Graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100. This outcomes measures the common toxicities observed. Please refer to the Serious Adverse Event and Other Adverse Event sections of the results for further details.

Groups in this outcome

V-BEAM + Stem Cell Infusion

Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
V-BEAM + Stem Cell Infusion10

Reported measurements

Neutropenic fever
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion10Not reportedNot reportedNot reportedNot reported
Clostridium difficile colitis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion3Not reportedNot reportedNot reportedNot reported
Neutropenic colitis without Clostridium difficile
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion3Not reportedNot reportedNot reportedNot reported
Sepsis
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion3Not reportedNot reportedNot reportedNot reported
Mucositis (grade 1-2)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion8Not reportedNot reportedNot reportedNot reported
Mucositis (grade 3-4)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion2Not reportedNot reportedNot reportedNot reported
Diarrhea (grade 3-4)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion10Not reportedNot reportedNot reportedNot reported
Hepatic toxicity (grade 3-4)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion1Not reportedNot reportedNot reportedNot reported
Peripheral neuropathy (grade 1-2)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion2Not reportedNot reportedNot reportedNot reported
Toxic death
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion2Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Neutropenic fever
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Clostridium difficile colitis
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Neutropenic colitis without Clostridium difficile
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
    title
    Sepsis
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        8
    title
    Mucositis (grade 1-2)
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Mucositis (grade 3-4)
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        10
    title
    Diarrhea (grade 3-4)
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Hepatic toxicity (grade 3-4)
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Peripheral neuropathy (grade 1-2)
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Toxic death
denoms
  1. counts
    1. group Id
      OG000
      value
      10
    units
    Participants
description
Graded per the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Patients are evaluated from first receiving study treatment until a 30-day follow-up after the conclusion of treatment for adverse events not resulting in death. Adverse events resulting in death will be evaluated through Day +100. This outcomes measures the common toxicities observed. Please refer to the Serious Adverse Event and Other Adverse Event sections of the results for further details.
groups
  1. description
    Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
    id
    OG000
    title
    V-BEAM + Stem Cell Infusion
param Type
NUMBER
reporting Status
POSTED
time Frame
30 days after end of treatment / Day +100
title
Toxicity of V-BEAM
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice