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NCT01653418 · OUTCOME

Number of Participants With Progression-free Survival (PFS)

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
Median follow-up of 6 months (range: 6.0-12.0 months)

What was measured

PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission. Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.

Analysis population: Two participants without evaluable responses due to early mortality were not included in this analysis.

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 Infusion8

Reported measurements

No relapse/progression
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion7Not reportedNot reportedNot reportedNot reported
Relapse/progression at 12 months
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        7
    title
    No relapse/progression
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        1
    title
    Relapse/progression at 12 months
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
PFS is defined as the duration from transplant to time of first progression, death, relapse after CR, or the date the patient was last known to be in remission. Response will be assessed per the International Myeloma Working Group (IMWG) Response Criteria.
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
population Description
Two participants without evaluable responses due to early mortality were not included in this analysis.
reporting Status
POSTED
time Frame
Median follow-up of 6 months (range: 6.0-12.0 months)
title
Number of Participants With Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice