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NCT00054353 · OUTCOME

OS

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
At 6 months and then every year thereafter, up to 5 years

What was measured

Number of subjects surviving. OS will be estimated by the method of Kaplan and Meier. Confidence intervals will be estimated.

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

6 Months
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Related Donor8Not reportedNot reportedNot reportedNot reported
Unrelated Donor3Not reportedNot reportedNot reportedNot reported
1 Year
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Related Donor5Not reportedNot reportedNot reportedNot reported
Unrelated Donor2Not reportedNot reportedNot reportedNot reported
2 Years
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Related Donor4Not reportedNot reportedNot reportedNot reported
Unrelated Donor0Not reportedNot reportedNot reportedNot reported
3 Years
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Related Donor3Not reportedNot reportedNot reportedNot reported
Unrelated Donor0Not reportedNot reportedNot reportedNot reported
4 Years
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Related Donor3Not reportedNot reportedNot reportedNot reported
Unrelated Donor0Not reportedNot reportedNot reportedNot reported
5 Years
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Related Donor3Not reportedNot reportedNot reportedNot reported
Unrelated Donor0Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        3
    title
    6 Months
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        2
    title
    1 Year
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        0
    title
    2 Years
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    3 Years
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    4 Years
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        0
    title
    5 Years
denoms
  1. counts
    1. group Id
      OG000
      value
      12
    2. group Id
      OG001
      value
      4
    units
    Participants
description
Number of subjects surviving. OS will be estimated by the method of Kaplan and Meier. Confidence intervals will be estimated.
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
At 6 months and then every year thereafter, up to 5 years
title
OS
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice