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NCT01453101 · OUTCOME

Overall Response Rate

Allogeneic Hematopoietic Stem Cell Transplantation for Multiple Myeloma · Source last updated 2026-04-08

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 3 years

What was measured

Overall response rate: Defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria. International Myeloma Working Group Response Criteria for Multiple Myeloma: CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h SD: Not meeting criteria for CR, VGPR, PR, or progressive disease

Groups in this outcome

Fludarabine, Melphalan, Bortezomib

Fludarabine monophosphate, melphalan, Bortezomib: •Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5. * Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2 * Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.

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

Analysis denominator · Participants

GroupSource count
Fludarabine, Melphalan, Bortezomib54

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Fludarabine, Melphalan, Bortezomib45Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        45
denoms
  1. counts
    1. group Id
      OG000
      value
      54
    units
    Participants
description
Overall response rate: Defined as the composite endpoint of response to treatment which includes Complete Response (CR), Partial Response (PR), stable disease (SD) as defined in International Response Criteria. International Myeloma Working Group Response Criteria for Multiple Myeloma: CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and \< 5% plasma cells in bone marrow PR: \> 50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by \>90% or to \< 200 mg/24 h SD: Not meeting criteria for CR, VGPR, PR, or progressive disease
groups
  1. description
    Fludarabine monophosphate, melphalan, Bortezomib: •Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5. * Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2 * Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan.
    id
    OG000
    title
    Fludarabine, Melphalan, Bortezomib
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 3 years
title
Overall Response Rate
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice