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NCT00793572 · OUTCOME

Number of Patients With Grade II-IV Acute GVHD

Autologous or Syngeneic Stem Cell Transplant Followed by Donor Stem Cell Transplant and Bortezomib in Treating Patients With Newly Diagnosed High-Risk, Relapsed, or Refractory Multiple Myeloma · Source last updated 2020-01-22

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
100 days post allo transplant

What was measured

Number of patients who developed acute GVHD post allogeneic transplant. aGVHD Stages Skin: 1. \- a maculopapular eruption involving \< 25% BSA 2. \- a maculopapular eruption involving 25 - 50% BSA 3. \- generalized erythroderma 4. \- generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. \- bilirubin 2.0 - 3.0 mg/100 mL 2. \- bilirubin 3 - 5.9 mg/100 mL 3. \- bilirubin 6 - 14.9 mg/100 mL 4. \- bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death

Groups in this outcome

Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy

See Detailed Description Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation Bortezomib: Given SC Cyclosporine: Given IV Cyclosporine: Given PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation Peripheral Blood Stem Cell Transplantation: Undergo transplantation Syngeneic Bone Marrow Transplantation: Undergo transplantation Total-Body Irradiation: Undergo radiotherapy

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

Analysis denominator · Participants

GroupSource count
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy32

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy14Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        14
denoms
  1. counts
    1. group Id
      OG000
      value
      32
    units
    Participants
description
Number of patients who developed acute GVHD post allogeneic transplant. aGVHD Stages Skin: 1. \- a maculopapular eruption involving \< 25% BSA 2. \- a maculopapular eruption involving 25 - 50% BSA 3. \- generalized erythroderma 4. \- generalized erythroderma w/ bullous formation and often w/ desquamation Liver: 1. \- bilirubin 2.0 - 3.0 mg/100 mL 2. \- bilirubin 3 - 5.9 mg/100 mL 3. \- bilirubin 6 - 14.9 mg/100 mL 4. \- bilirubin \> 15 mg/100 mL Gut: Diarrhea is graded 1 - 4 in severity. Nausea and vomiting and/or anorexia caused by GVHD is assigned as 1 in severity. The severity of gut involvement is assigned to the most severe involvement noted. Patients with visible bloody diarrhea are at least stage 2 gut and grade 3 overall. aGVHD Grades Grade II: Stage 1 - 2 skin w/ no gut/liver involvement Grade III: Stage 2 - 4 gut involvement and/or stage 2 - 4 liver involvement Grade IV: Pattern and severity of GVHD similar to grade 3 w/ extreme constitutional symptoms or death
groups
  1. description
    See Detailed Description Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation Bortezomib: Given SC Cyclosporine: Given IV Cyclosporine: Given PO Fludarabine Phosphate: Given IV Laboratory Biomarker Analysis: Correlative studies Melphalan: Given IV Mycophenolate Mofetil: Given PO Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation Peripheral Blood Stem Cell Transplantation: Undergo transplantation Syngeneic Bone Marrow Transplantation: Undergo transplantation Total-Body Irradiation: Undergo radiotherapy
    id
    OG000
    title
    Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy
param Type
COUNT_OF_PARTICIPANTS
reporting Status
POSTED
time Frame
100 days post allo transplant
title
Number of Patients With Grade II-IV Acute GVHD
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice