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NCT00006244 · OUTCOME

Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity

Melphalan, Peripheral Stem Cell Transplantation, and Interleukin-2 Followed by Interferon Alfa in Treating Patients With Advanced Multiple Myeloma · Source last updated 2017-07-12

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
First 100 days post-transplant

What was measured

Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (\< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.

Analysis population: Of the 36 patients, 20 patients were \<56 years old and these 20 patients are used to determine this outcome measure.

Groups in this outcome

Immunotherapy Treatment

Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity. melphalan: Given IV recombinant interferon alfa: Given SC aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion

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

Analysis denominator · Participants

GroupSource count
Immunotherapy Treatment20

Reported measurements

Source class 1
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Immunotherapy Treatment1Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
denoms
  1. counts
    1. group Id
      OG000
      value
      20
    units
    Participants
description
Grade 3-4 toxicities by the Bearman common toxicity criteria, encountered by younger (\< 56 years old) advanced multiple myeloma patients treated with melphalan, IL2-incubated peripheral blood stem cells, and sequential IL2.
groups
  1. description
    Patients receive melphalan IV over 2-3 hours on day -2 and an infusion of IL-2-treated autologous or syngeneic peripheral blood stem cells on day 0. Beginning on day 0, patients also receive IL-2 IV continuously over 5 days followed by 2 days off. Treatment with IL-2 repeats weekly for 4 weeks. Beginning 1 month later, patients undergo maintenance therapy comprising interferon alfa SC 3 times a week in the absence of disease progression or unacceptable toxicity. melphalan: Given IV recombinant interferon alfa: Given SC aldesleukin: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion in vitro-treated peripheral blood stem cell transplantation: Undergo IL2-treated autologous or syngeneic peripheral blood stem infusion
    id
    OG000
    title
    Immunotherapy Treatment
param Type
COUNT_OF_PARTICIPANTS
population Description
Of the 36 patients, 20 patients were \<56 years old and these 20 patients are used to determine this outcome measure.
reporting Status
POSTED
time Frame
First 100 days post-transplant
title
Number of Patients <56 Years Old Experiencing Grade 3-4 Regimen Related Toxicity
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice