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NCT00054353 · OUTCOME

Incidence of Acute GVHD (Grades III-IV)

Reduced-Intensity Conditioning Followed By Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Multiple Myeloma · Source last updated 2017-10-16

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 5 years

What was measured

Number of patients with Grade III-IV acute GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.

Groups in this outcome

Related Donor

PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s

Unrelated Donor

PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s

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

Analysis denominator · Participants

GroupSource count
Related Donor12
Unrelated Donor4

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Related Donor2Not reportedNot reportedNot reportedNot reported
Unrelated Donor0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        0
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Number of patients with Grade III-IV acute GVHD post-transplant. Severe GVHD will be monitored in a sequential fashion.
groups
  1. description
    PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s
    id
    OG000
    title
    Related Donor
  2. description
    PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -3 and intermediate-dose melphalan IV over 15-20 minutes on day -2. Patients also undergo low-dose TBI on day 0. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. IMMUNOSUPPRESSION: Patients receive cyclosporine PO BID on days -3 to 80 with taper to day 180 (related donors) or on days -3 to 100 with taper to day 180 (unrelated donors). Patients also receive mycophenolate mofetil PO BID on days 0-27 (related donors) or TID on days 0-40 with taper to day 96 (unrelated donors). fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI mycophenolate mofetil: Given PO cyclosporine: Given PO nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT peripheral blood stem cell transplantation: Undergo reduced-intensity allogeneic PBSCT laboratory biomarker analysis: Correlative s
    id
    OG001
    title
    Unrelated Donor
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
Up to 5 years
title
Incidence of Acute GVHD (Grades III-IV)
type
PRIMARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice