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NCT00577096 · OUTCOME

Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)

Effects of Exercise in Combination With Epoetin Alfa · Source last updated 2015-04-06

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

Measure
MEAN
Unit
g/dl
Interval / dispersion
Standard Deviation
Time frame
up to 15 weeks

What was measured

Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.

Analysis population: For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).

Groups in this outcome

Usual Care

Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (\<=60 versus \>60).Participants who received thalidomide also received low-molecular weight heparin

Exercise

Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (\<=60 versus \>60). Participants who received thalidomide also received low-molecular weight heparin.

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

Analysis denominator · Participants

GroupSource count
Usual Care28
Exercise23

Reported measurements

Baseline
Values in g/dl · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Usual Care12.11.6Not reportedNot reportedNot reported
Exercise11.61.7Not reportedNot reportedNot reported
Before transplantation
Values in g/dl · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Usual Care10.81.5Not reportedNot reportedNot reported
Exercise11.01.6Not reportedNot reportedNot reported
During transplantation
Values in g/dl · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Usual Care10.10.7Not reportedNot reportedNot reported
Exercise10.40.9Not reportedNot reportedNot reported
At discharge
Values in g/dl · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Usual Care10.61.4Not reportedNot reportedNot reported
Exercise10.61.1Not reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Pct Value
    95
    group Description
    The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    T-test and chi-squared to check for equivalence of groups for age, race and gender.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    <0.025
    p Value Comment
    Bonferroni adjusted p-value for multiple comparisons.
    statistical Method
    ANOVA
    tested Non Inferiority
    true
Complete source fields
analyses
  1. ci Pct Value
    95
    group Description
    The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Comment
    T-test and chi-squared to check for equivalence of groups for age, race and gender.
    non Inferiority Type
    NON_INFERIORITY_OR_EQUIVALENCE
    p Value
    <0.025
    p Value Comment
    Bonferroni adjusted p-value for multiple comparisons.
    statistical Method
    ANOVA
    tested Non Inferiority
    true
anticipated Posting Date
2011-02
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.6
        value
        12.1
      2. group Id
        OG001
        spread
        1.7
        value
        11.6
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.5
        value
        10.8
      2. group Id
        OG001
        spread
        1.6
        value
        11.0
    title
    Before transplantation
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.7
        value
        10.1
      2. group Id
        OG001
        spread
        0.9
        value
        10.4
    title
    During transplantation
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        1.4
        value
        10.6
      2. group Id
        OG001
        spread
        1.1
        value
        10.6
    title
    At discharge
denoms
  1. counts
    1. group Id
      OG000
      value
      28
    2. group Id
      OG001
      value
      23
    units
    Participants
description
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.
dispersion Type
Standard Deviation
groups
  1. description
    Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (\<=60 versus \>60).Participants who received thalidomide also received low-molecular weight heparin
    id
    OG000
    title
    Usual Care
  2. description
    Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (\<=60 versus \>60). Participants who received thalidomide also received low-molecular weight heparin.
    id
    OG001
    title
    Exercise
param Type
MEAN
population Description
For the exercise group 8 participants who entered the study were not included in the analysis (2 withdrew from myeloma treatment, 1 died, 5 withdrew from study). For the usual care group 7 were not included in the analysis (3 withdrew from myeloma treatment, 1 died, 3 withdrew from study).
reporting Status
POSTED
time Frame
up to 15 weeks
title
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
type
SECONDARY
unit Of Measure
g/dl

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

Preserved source evidence · Not medical advice