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NCT02416206 · OUTCOME

To Estimate the Response at Day 100 Following Transplant (Rate of CR)

High Dose Chemotherapy Using BeEAM for Autologous Transplant in Multiple Myeloma · Source last updated 2023-05-18

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
Day 100

What was measured

Using IMWG criteria: PR (partial response) noted as \>50% reduction of serum M-protein and reduction in 24hr urinary M-protein by \>90% or to \<200mg/24h; VgPR (very good partial response) noted as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; CR (complete response) noted as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow; sCR (stringent complete response) noted as CR defined above plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.

Groups in this outcome

BeEAM

Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM

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

Analysis denominator · Participants

GroupSource count
BeEAM65

Reported measurements

Source class 1

Complete Response (CR1)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BeEAM26Not reportedNot reportedNot reportedNot reported

Very Good Partial Response (VGPR1)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BeEAM32Not reportedNot reportedNot reportedNot reported

Partial Response (PR1)

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
BeEAM7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        26
      title
      Complete Response (CR1)
    2. measurements
      1. group Id
        OG000
        value
        32
      title
      Very Good Partial Response (VGPR1)
    3. measurements
      1. group Id
        OG000
        value
        7
      title
      Partial Response (PR1)
denoms
  1. counts
    1. group Id
      OG000
      value
      65
    units
    Participants
description
Using IMWG criteria: PR (partial response) noted as \>50% reduction of serum M-protein and reduction in 24hr urinary M-protein by \>90% or to \<200mg/24h; VgPR (very good partial response) noted as serum and urine M-protein detectable by immunofixation but not on electrophoresis or \>90% reduction in serum M-protein plus urine M-protein level \<100mg/24h; CR (complete response) noted as negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \<5% plasma cells in bone marrow; sCR (stringent complete response) noted as CR defined above plus normal FLC ratio and absence of clonal cells in bone marrow by immunohistochemistry or immunofluorescence.
groups
  1. description
    Bendaumustine, Etoposide, Cytrabine and Melphalan in autologous transplant for multiple myeloma BeEAM: BeEAM
    id
    OG000
    title
    BeEAM
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Day 100
title
To Estimate the Response at Day 100 Following Transplant (Rate of CR)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice