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NCT01237951 · OUTCOME

Participants Who Had Measurable Disease at Time of Transplant and Achieved a Stringent Complete Remission

High-Dose Gemcitabine, Busulfan and Melphalan With Hematopoietic-Cell Support for Patients With Poor-Risk Myeloma · Source last updated 2020-05-05

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
100 days post-transplant

What was measured

Stringent complete remission was defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, 5% or fewer plasma cells in bone marrow, normal free light chain ratio, and the absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

Analysis population: Only 65 participants had measurable disease at the time of ASCT.

Groups in this outcome

Gemcitabine/Busulfan/Melphalan

Patients with refractory or relapsed myeloma received high-dose GemBuMel with ASCT

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

Analysis denominator · Participants

GroupSource count
Gemcitabine/Busulfan/Melphalan65

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Gemcitabine/Busulfan/Melphalan16Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        16
denoms
  1. counts
    1. group Id
      OG000
      value
      65
    units
    Participants
description
Stringent complete remission was defined as negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, 5% or fewer plasma cells in bone marrow, normal free light chain ratio, and the absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
groups
  1. description
    Patients with refractory or relapsed myeloma received high-dose GemBuMel with ASCT
    id
    OG000
    title
    Gemcitabine/Busulfan/Melphalan
param Type
COUNT_OF_PARTICIPANTS
population Description
Only 65 participants had measurable disease at the time of ASCT.
reporting Status
POSTED
time Frame
100 days post-transplant
title
Participants Who Had Measurable Disease at Time of Transplant and Achieved a Stringent Complete Remission
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice