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NCT01690143 · OUTCOME

Very Good Partial Response (VGPR) Rate.

Carfilzomib + High Dose Melphalan as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation · Source last updated 2018-08-07

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 17 months

What was measured

VGPR defined as any one of the following: ≥ 90% reduction of serum M-protein; ≥ 90% reduction in 24-hour urinary M-protein or decrease to \< 100 mg per 24 hour; ≥ 50% decrease in the difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio; ≥ 50% reduction in bone marrow plasma cells; ≥ 50% reduction in the size of soft tissue plasmacytomas.

Analysis population: All patients who underwent transplantation

Groups in this outcome

Patients Undergoing Transplantation

All patients who receive transplant in the phase 1+2 of the study

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

Analysis denominator · Participants

GroupSource count
Patients Undergoing Transplantation44

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Patients Undergoing Transplantation26Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
denoms
  1. counts
    1. group Id
      OG000
      value
      44
    units
    Participants
description
VGPR defined as any one of the following: ≥ 90% reduction of serum M-protein; ≥ 90% reduction in 24-hour urinary M-protein or decrease to \< 100 mg per 24 hour; ≥ 50% decrease in the difference between involved and uninvolved FLC levels or a 50% decrease in level of involved FLC with 50% decrease in ratio; ≥ 50% reduction in bone marrow plasma cells; ≥ 50% reduction in the size of soft tissue plasmacytomas.
groups
  1. description
    All patients who receive transplant in the phase 1+2 of the study
    id
    OG000
    title
    Patients Undergoing Transplantation
param Type
COUNT_OF_PARTICIPANTS
population Description
All patients who underwent transplantation
reporting Status
POSTED
time Frame
Up to 17 months
title
Very Good Partial Response (VGPR) Rate.
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice