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NCT01534143 · OUTCOME

Incidence and Severity of Acute GVHD Using Fludarabine Phosphate / Busulfan / Bortezomib Preparative Regimen and Triple Immune Suppression With Tacrolimus, Sirolimus and Anti-thymocyte Globulin

High Dose Busulfan and Bortezomib in Treating Patients With High Risk Multiple Myeloma Undergoing Stem Cell Transplant · Source last updated 2017-04-05

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
First 6 months post-transplant

What was measured

Graded using the Glucksberg scale. Proportions and confidence intervals will be estimated. Estimated using binary proportion estimates as well as competing risk method.

Analysis population: Data was not collected, because funding was unavailable to continue study.

Groups in this outcome

Treatment (Chemotherapy, Enzyme Inhibitor)

CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2. GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0. anti-thymocyte globulin : Given IV pharmacological study : Correlative studies fludarabine phosphate : Given IV busulfan : Given IV bortezomib : Given IV allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT tacrolimus : Given IV laboratory biomarker analysis : Correlative studies sirolimus : Given PO

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

Analysis denominator · Participants

GroupSource count
Treatment (Chemotherapy, Enzyme Inhibitor)0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    units
    Participants
description
Graded using the Glucksberg scale. Proportions and confidence intervals will be estimated. Estimated using binary proportion estimates as well as competing risk method.
groups
  1. description
    CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2. GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0. anti-thymocyte globulin : Given IV pharmacological study : Correlative studies fludarabine phosphate : Given IV busulfan : Given IV bortezomib : Given IV allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT tacrolimus : Given IV laboratory biomarker analysis : Correlative studies sirolimus : Given PO
    id
    OG000
    title
    Treatment (Chemotherapy, Enzyme Inhibitor)
population Description
Data was not collected, because funding was unavailable to continue study.
reporting Status
POSTED
time Frame
First 6 months post-transplant
title
Incidence and Severity of Acute GVHD Using Fludarabine Phosphate / Busulfan / Bortezomib Preparative Regimen and Triple Immune Suppression With Tacrolimus, Sirolimus and Anti-thymocyte Globulin
type
PRIMARY

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

Preserved source evidence · Not medical advice