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NCT01605032 · OUTCOME

Overall Response Rate

Busulfan, Melphalan, and Bortezomib Before First-Line Stem Cell Transplant in Treating Patients With Multiple Myeloma · Source last updated 2020-08-20

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

Measure
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
Up to day 100

What was measured

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Groups in this outcome

Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)

CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4. TRANSPLANT: Patients undergo autologous PBSCT on day 0. Busulfan: Given IV Melphalan: Given IV Bortezomib: Given IV Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT

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

Analysis denominator · Participants

GroupSource count
Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)19

Reported measurements

Complete response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)2Not reportedNot reportedNot reportedNot reported
Partial response
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)17Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    title
    Complete response
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        17
    title
    Partial response
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    units
    Participants
description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
groups
  1. description
    CONDITIONING: Patients receive busulfan IV over 3 hours on days -6 to -3, melphalan IV over 20 minutes on day -2, and bortezomib IV over 3-5 seconds on days -6, -3, 1, and 4. TRANSPLANT: Patients undergo autologous PBSCT on day 0. Busulfan: Given IV Melphalan: Given IV Bortezomib: Given IV Autologous Hematopoietic Stem Cell Transplantation: Undergo autologous PBSCT Peripheral Blood Stem Cell Transplantation: Undergo autologous PBSCT
    id
    OG000
    title
    Treatment (Busulfan, Melphalan, Bortezomib, Autologous PBSCT)
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to day 100
title
Overall Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice