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NCT00793650 · OUTCOME

Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.

Combination High Dose Melphalan and Autologous Peripheral Blood Stem Cell (PBSC) Transplant With Bortezomib for Multiple Myeloma: A Dose and Schedule Finding Study · Source last updated 2012-08-30

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

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
100 days after transplant

What was measured

CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 hour. Partial Response:\>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200mg per 24 hour.

Analysis population: As per the protocol.

Groups in this outcome

Bortezomib Before Melphalan

All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2

Bortezomib After Melphalan

patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2

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

Analysis denominator · Participants

GroupSource count
Bortezomib Before Melphalan19
Bortezomib After Melphalan20

Reported measurements

Complete response (CR)
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib Before Melphalan2Not reportedNot reportedNot reportedNot reported
Bortezomib After Melphalan6Not reportedNot reportedNot reportedNot reported
VGPR-Very good partial remission
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib Before Melphalan9Not reportedNot reportedNot reportedNot reported
Bortezomib After Melphalan11Not reportedNot reportedNot reportedNot reported
Partial Response
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Bortezomib Before Melphalan6Not reportedNot reportedNot reportedNot reported
Bortezomib After Melphalan7Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        6
    title
    Complete response (CR)
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        11
    title
    VGPR-Very good partial remission
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        6
      2. group Id
        OG001
        value
        7
    title
    Partial Response
denoms
  1. counts
    1. group Id
      OG000
      value
      19
    2. group Id
      OG001
      value
      20
    units
    Participants
description
CR :Negative immunofixation on the serum and urine and Disappearance of any soft tissue plasmacytomas and \<=5% plasma cells in bone marrow. VGPR: Serum and urine M-protein detectable by immunofixation but not on electrophoresis or 90% or greater reduction in serum M-protein plus urine M-protein level \<100mg per 24 hour. Partial Response:\>=50% reduction of serum M-protein and reduction in 24-hour urinary M-protein by \>=90% or to \<200mg per 24 hour.
groups
  1. description
    All patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
    id
    OG000
    title
    Bortezomib Before Melphalan
  2. description
    patients received melphalan (100 mg/m\^2/day × 2; days -3 and -2), for a total dose of 200 mg/m\^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m\^2
    id
    OG001
    title
    Bortezomib After Melphalan
param Type
NUMBER
population Description
As per the protocol.
reporting Status
POSTED
time Frame
100 days after transplant
title
Response Rate Using EBMT(European Group for Blood and Bone Marrow Transplan) Criteria at Day +100 After Transplant.
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice