Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02489500 · OUTCOME

Number of Participants With Hematologic Response

Trial of High Dose Melphalan/Stem Cell Transplant With or Without Bortezomib · Source last updated 2018-09-10

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
6 months

What was measured

Hematologic response defined as: at least 50% improvement in the difference between involved and uninvolved free light chains

Analysis population: Two participants were not evaluable as they expired and did not have a post-treatment response evaluation.

Groups in this outcome

Melphalan

Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells

Melphalan + Bortezomib

Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion Bortezomib: Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells

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

Analysis denominator · Participants

GroupSource count
Melphalan1
Melphalan + Bortezomib0

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Melphalan0Not reportedNot reportedNot reportedNot reported
Melphalan + Bortezomib0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      1
    2. group Id
      OG001
      value
      0
    units
    Participants
description
Hematologic response defined as: at least 50% improvement in the difference between involved and uninvolved free light chains
groups
  1. description
    Neupogen 16mcg/kg x 4 days Stem cell collection Drug: high dose melphalan 140 or 200 mg/m2 stem cell infusion Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
    id
    OG000
    title
    Melphalan
  2. description
    Neupogen 16mcg/kg x 4 days Stem Cell collection drug: high-dose melphalan 140 or 200 mg/m2 drug: Bortezomib 1.0 mg/m2/dose x 4 doses stem cell infusion Bortezomib: Conditioning Regimen: Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Melphalan: Conditioning Regimen: Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0 Neupogen: granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days Stem Cell Collection: collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells Stem cell infusion: infusion of previously collected autologous stem cells
    id
    OG001
    title
    Melphalan + Bortezomib
param Type
COUNT_OF_PARTICIPANTS
population Description
Two participants were not evaluable as they expired and did not have a post-treatment response evaluation.
reporting Status
POSTED
time Frame
6 months
title
Number of Participants With Hematologic Response
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice