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NCT01529827 · OUTCOME

Clinical Response

Fludarabine Phosphate, Melphalan, and Low-Dose Total-Body Irradiation Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies · Source last updated 2019-09-24

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

Measure
NUMBER
Unit
percentage of participants
Interval / dispersion
95% Confidence Interval
Time frame
In the first 100 days from day 0 of transplant

What was measured

Patients will be followed according to response criteria as referenced in BMT SOP "Standards of Therapy" last updated 2008. Clinical Response = CR + PR. Complete Response Requires all of the following: * Serum and urine negative for monoclonal proteins by immunofixation * Normal free light chain ratio * Plasma cells in marrow \< 5% Partial Response (PR) Requires any of the following: \- ≥ 50% reduction in current serum monoclonal protein levels \> 0.5 g/dL or urine light chain levels \> 100 mg/day with a visible peak or free light chain levels \> 10mg/dL Progressive Disease (PD) Requires any of the following: * If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double) * If progressive from PR or SD, ≥ 50% increase in the serum M protein to \> 0.5 g/dL,or ≥ 50% increase in urine M protein to \> 200mg/day with visible peak present. * Free light chain increase of ≥ 50% to

Analysis population: All treated and eligible patients

Groups in this outcome

Treatment (Reduced Intensity Allogeneic PBSCT)

PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT

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 (Reduced Intensity Allogeneic PBSCT)94

Reported measurements

Source class 1
Values in percentage of participants · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
Treatment (Reduced Intensity Allogeneic PBSCT)45Not reported3455Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        34
        upper Limit
        55
        value
        45
denoms
  1. counts
    1. group Id
      OG000
      value
      94
    units
    Participants
description
Patients will be followed according to response criteria as referenced in BMT SOP "Standards of Therapy" last updated 2008. Clinical Response = CR + PR. Complete Response Requires all of the following: * Serum and urine negative for monoclonal proteins by immunofixation * Normal free light chain ratio * Plasma cells in marrow \< 5% Partial Response (PR) Requires any of the following: \- ≥ 50% reduction in current serum monoclonal protein levels \> 0.5 g/dL or urine light chain levels \> 100 mg/day with a visible peak or free light chain levels \> 10mg/dL Progressive Disease (PD) Requires any of the following: * If progressing from CR, any detectable monoclonal protein or abnormal free light chain ratio (light chain must double) * If progressive from PR or SD, ≥ 50% increase in the serum M protein to \> 0.5 g/dL,or ≥ 50% increase in urine M protein to \> 200mg/day with visible peak present. * Free light chain increase of ≥ 50% to
dispersion Type
95% Confidence Interval
groups
  1. description
    PREPARATIVE REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan IV over 30 minutes on day -2. Patients undergo low-dose TBI BID on day -1. TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0. GvHD PROPHYLAXIS: Patients receive tacrolimus IV or PO BID on days -1 to 100 with taper over 4-6 months, MMF PO or IV every 6-8 hours on days -1 to 60, and methotrexate IV over 15 to 30 minutes on days 1, 3, and 6. fludarabine phosphate: Given IV melphalan: Given IV total-body irradiation: Undergo TBI tacrolimus: Given IV or PO mycophenolate mofetil: Given IV or PO methotrexate: Given IV laboratory biomarker analysis: Correlative studies allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT peripheral blood stem cell transplantation: Undergo PBSCT
    id
    OG000
    title
    Treatment (Reduced Intensity Allogeneic PBSCT)
param Type
NUMBER
population Description
All treated and eligible patients
reporting Status
POSTED
time Frame
In the first 100 days from day 0 of transplant
title
Clinical Response
type
SECONDARY
unit Of Measure
percentage of participants

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

Preserved source evidence · Not medical advice