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NCT00185614 · OUTCOME

Event-free Survival (EFS)

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
COUNT_OF_PARTICIPANTS
Unit
Participants
Interval / dispersion
Not reported
Time frame
3 years

What was measured

Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. "Event" was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years.

Analysis population: The outcome data are reported as the number of participants who do not experience an EFS event within 3 years from the date of the last transplant, for the "Auto-HCT only" population, the "Auto-HCT then Allo-HCT" population, and the overall study population (ie, "Auto-HCT only" plus +"Auto-HCT then Allo-HCT").

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-HCT0Not 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-HCT24Not 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-HCT24Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        0
    denoms
    1. counts
      1. group Id
        OG000
        value
        4
      units
      Participants
    title
    Auto-HCT only
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        24
    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
        24
    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
Event-free survival (EFS) as determined for all participants who received the initial Auto-HCT treatment. "Event" was defined as any of the following within 3 years of the participant's last infusion of Auto-HCT or Allo-HCT: relapse; death; or last follow-up if there is no data to document the participant remained alive at 3 years.
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
COUNT_OF_PARTICIPANTS
population Description
The outcome data are reported as the number of participants who do not experience an EFS event within 3 years from the date of the last transplant, for the "Auto-HCT only" population, the "Auto-HCT then Allo-HCT" population, and the overall study population (ie, "Auto-HCT only" plus +"Auto-HCT then Allo-HCT").
reporting Status
POSTED
time Frame
3 years
title
Event-free Survival (EFS)
type
PRIMARY
unit Of Measure
Participants

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Preserved source evidence · Not medical advice