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NCT01534143 · OUTCOME

Grade III and IV Non Hematologic Toxicities

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

Based on NCI CTCAE version 4.

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
Based on NCI CTCAE version 4.
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)
reporting Status
POSTED
time Frame
First 6 months post transplant
title
Grade III and IV Non Hematologic Toxicities
type
PRIMARY

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

Preserved source evidence · Not medical advice