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NCT00185614 · OUTCOME

Relapse Rate

Non-myeloablative Allogeneic Transplantation for the Treatment of Multiple Myeloma · Source last updated 2018-01-18

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
3 years

What was measured

Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein \>25%; bone marrow plasmacytosis \>25%; or bone lesions on skeletal survey (any increase).

Analysis population: The outcome data are reported as the number of participants who relapse per criteria within 3 years.

Groups in this outcome

Auto- Then Allo-HCT

Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.

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

Analysis denominator · Participants

GroupSource count
Auto- Then Allo-HCT63

Reported measurements

Auto-HCT only

Analysis denominator · Participants

GroupSource count
Auto- Then Allo-HCT4
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Auto- Then Allo-HCT2Not reportedNot reportedNot reportedNot reported
Auto-HCT then Allo-HCT

Analysis denominator · Participants

GroupSource count
Auto- Then Allo-HCT59
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Auto- Then Allo-HCT29Not reportedNot reportedNot reportedNot reported
All Participants

Analysis denominator · Participants

GroupSource count
Auto- Then Allo-HCT63
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Auto- Then Allo-HCT31Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Auto-HCT only
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        29
    denoms
    1. counts
      1. group Id
        OG000
        value
        59
      units
      Participants
    title
    Auto-HCT then Allo-HCT
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        31
    denoms
    1. counts
      1. group Id
        OG000
        value
        63
      units
      Participants
    title
    All Participants
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    units
    Participants
description
Relapse rate as determined for all participants who received the initial Auto-HCT treatment. Relapse was protocol-specified as progressive disease, indicated by an increase as compared to pre-Auto-HCT baseline, of serum or urine monoclonal protein \>25%; bone marrow plasmacytosis \>25%; or bone lesions on skeletal survey (any increase).
groups
  1. description
    Auto-HCT mobilization is cyclophosphamide 4 g/m2 + filgrastim 10 µg/kg/day for peripheral blood progenitor cell (PBPC) collection by apheresis. Transplant conditioning is high-dose melphalan 200 mg/m2, followed by PBPC infusion as melphalan rescue \[ie, autologous hematopoietic cells transplant (Auto-HCT)\]. Post-infusion support is filgrastim 5 µg/kg/day, starting 6 days after melphalan. Stable/responsive disease at 4 weeks continues to allogenic HCT (Allo-HCT) from sibling donor fully-matched for human leukocyte antigen (HLA). Allo-HCT conditioning is total body irradiation (TBI) 200 centigray (cGy) + cyclosporine (CSP) 6.25 mg/kg + mycophenolate mofetil (MMF) 15 mg/kg. Donor mobilization is filgrastim 16 µg/kg/day on day -4 to Day 0; apheresis collections on Day -1 \& Day 0, to a target of \> 5 x 10e6 CD34 cells/kg. Allo-HCT is infused to participant on Day 0, with premedication hydrocortisone 100 mg IV \& diphenhydramine 50 mg IV. CSP tapering on Day 56 to Day 180, adjusted as needed.
    id
    OG000
    title
    Auto- Then Allo-HCT
param Type
NUMBER
population Description
The outcome data are reported as the number of participants who relapse per criteria within 3 years.
reporting Status
POSTED
time Frame
3 years
title
Relapse Rate
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice