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NCT00577096 · OUTCOME

Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long 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
Platelet Transfusions
Interval / dispersion
Standard Deviation
Time frame
up to 30 weeks

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 Care34
Exercise35

Reported measurements

Source class 1
Values in Platelet Transfusions · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Usual Care3.64.5Not reportedNot reportedNot reported
Exercise2.02.0Not 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 Comment
    This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.
    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 Comment
    This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.
    statistical Method
    ANOVA
    tested Non Inferiority
    true
anticipated Posting Date
2011-02
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        4.5
        value
        3.6
      2. group Id
        OG001
        spread
        2.0
        value
        2.0
denoms
  1. counts
    1. group Id
      OG000
      value
      34
    2. group Id
      OG001
      value
      35
    units
    Participants
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 30 weeks
title
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
type
PRIMARY
unit Of Measure
Platelet Transfusions

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Preserved source evidence · Not medical advice