Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00185614 · OUTCOME

Chronic Graft-vs-Host-Disease (cGvHD)

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

Development of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as "Extensive cGvHD;" "cGvHD, Not Extensive;" or "No cGvHD," as determined by investigator judgement (no protocol-specified criteria).

Analysis population: Graft versus host disease (aGvHD) only occurs in participants receiving 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-HCT59

Reported measurements

Source class 1

Extensive cGvHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Auto- Then Allo-HCT30Not reportedNot reportedNot reportedNot reported

cGvHD, not Extensive

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Auto- Then Allo-HCT8Not reportedNot reportedNot reportedNot reported

No cGvHD

Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Auto- Then Allo-HCT21Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        30
      title
      Extensive cGvHD
    2. measurements
      1. group Id
        OG000
        value
        8
      title
      cGvHD, not Extensive
    3. measurements
      1. group Id
        OG000
        value
        21
      title
      No cGvHD
denoms
  1. counts
    1. group Id
      OG000
      value
      59
    units
    Participants
description
Development of chronic graft versus host disease (cGvHD) within 3 years, for participants receiving Allo-HCT. Reported as "Extensive cGvHD;" "cGvHD, Not Extensive;" or "No cGvHD," as determined by investigator judgement (no protocol-specified criteria).
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
Graft versus host disease (aGvHD) only occurs in participants receiving Allo-HCT.
reporting Status
POSTED
time Frame
3 years
title
Chronic Graft-vs-Host-Disease (cGvHD)
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice