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NCT01653418 · OUTCOME

Overall Response Rate (ORR)

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
3 months following Day +100 visit

What was measured

ORR includes Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR) 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

Partial response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion0Not reportedNot reportedNot reportedNot reported
Very good partial response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion2Not reportedNot reportedNot reportedNot reported
Complete response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
V-BEAM + Stem Cell Infusion6Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    title
    Partial response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Very good partial response
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
    title
    Complete response
denoms
  1. counts
    1. group Id
      OG000
      value
      8
    units
    Participants
description
ORR includes Partial Response (PR) + Very Good Partial Response (VGPR) + Complete Response (CR) 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
3 months following Day +100 visit
title
Overall Response Rate (ORR)
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice