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Trial record 90 of 107 for:    "Vascular Hemostatic Disease" | "Doxorubicin"

Effects of Exercise in Combination With Epoetin Alfa

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ClinicalTrials.gov Identifier: NCT00577096
Recruitment Status : Completed
First Posted : December 19, 2007
Results First Posted : April 21, 2011
Last Update Posted : April 6, 2015
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by:
University of Arkansas

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Condition Multiple Myeloma
Interventions Drug: Epoetin Alfa
Behavioral: Exercise
Biological: Autologous Peripheral Blood Stem Cell Transplantation
Biological: Red Blood Cell Transfusion
Drug: Thalidomide
Drug: Heparin, Low-Molecular-Weight
Biological: Platelet Transfusion
Drug: Melphalan
Drug: Total Therapy II
Enrollment 120
Recruitment Details Study conducted at multiple myeloma international referral center included patients newly diagnosed & eligible for treatment with aggressive treatment. Protocol included tandem peripheral blood stem cell transplants.
Pre-assignment Details  
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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 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.
Period Title: Short Term Participation
Started 69 66
Completed 62 58
Not Completed 7 8
Reason Not Completed
withdrew from multiple myeloma treatment             3             2
Withdrawal by Subject             3             5
Death             1             1
Period Title: Long Term Participation
Started 34 [1] 35 [2]
Completed 34 35 [3]
Not Completed 0 0
[1]
Only the first 34 patients who met long-term eligibility (response to EPO) were enrolled.
[2]
Only 35 patients who met long-term eligibility (response to EPO) were enrolled.
[3]
Sub-set of patients (n=69) who completed short term (n=120) continued in long term participation.
Arm/Group Title Usual Care Exercise Total
Hide Arm/Group 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 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. Total of all reporting groups
Overall Number of Baseline Participants 69 66 135
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 69 participants 66 participants 135 participants
Short Term Participants 58  (9.2) 54.5  (10.4) 55  (10)
Long Term Participants 54.4  (9.7) 55.4  (11.4) 55  (10.6)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 66 participants 135 participants
Male (short term study) 13 12 25
Female (short term study) 22 19 41
Male (long term study) 24 23 47
Female (long term study) 10 12 22
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 69 participants 66 participants 135 participants
Caucasian (short term study) 31 27 58
Other (short term study) 4 4 8
Caucasian (long term study) 32 31 63
Other (long term study) 2 4 6
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 69 participants 66 participants 135 participants
69 66 135
1.Primary Outcome
Title Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
Hide Description The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.
Time Frame up to 15 weeks
Hide Outcome Measure Data
Hide Analysis 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).
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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
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.
Overall Number of Participants Analyzed 28 23
Mean (Standard Deviation)
Unit of Measure: RBC Transfusions
2.3  (2.5) 1.8  (2.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Exercise
Comments The null hypothesis was that there would be no difference between groups for the number of RBC transfusions.
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA
Statistical Test of Hypothesis P-Value <0.025
Comments Bonferroni adjusted p-value for multiple comparisons.
Method ANOVA
Comments This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.
2.Primary Outcome
Title Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
Hide Description The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.
Time Frame up to 30 weeks
Hide Outcome Measure Data
Hide Analysis 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).
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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
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.
Overall Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: RBC Transfusions
1.8  (2.9) 1.0  (1.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Exercise
Comments The null hypothesis is that there was no difference in the number of RBC tranfusions in the exercise versus usual care groups. Data was combined from the short and long term RBC transfusions.
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA
Statistical Test of Hypothesis P-Value <0.025
Comments Bonferroni adjusted p-value for multiple comparisons.
Method ANOVA
Comments This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.
3.Primary Outcome
Title Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
Hide Description [Not Specified]
Time Frame up to 15 weeks
Hide Outcome Measure Data
Hide Analysis 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).
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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
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.
Overall Number of Participants Analyzed 28 23
Mean (Standard Deviation)
Unit of Measure: Platelet transfusions
3.1  (3.2) 2.3  (1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Exercise
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments T-test and chi-squared test to check for equivalence of groups for age, race and gender.
Statistical Test of Hypothesis P-Value <0.025
Comments Bonferroni adjusted p-value for multiple comparisons.
Method ANOVA
Comments Analysis included short and long term participants.
4.Primary Outcome
Title Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
Hide Description [Not Specified]
Time Frame up to 30 weeks
Hide Outcome Measure Data
Hide Analysis 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).
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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
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.
Overall Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: Platelet Transfusions
3.6  (4.5) 2.0  (2.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Exercise
Comments The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.
Type of Statistical Test Non-Inferiority or Equivalence
Comments T-test and chi-squared to check for equivalence of groups for age, race and gender.
Statistical Test of Hypothesis P-Value <0.025
Comments Bonferroni adjusted p-value for multiple comparisons.
Method ANOVA
Comments This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.
5.Primary Outcome
Title Number of Stem Cell Collection Attempts (Short Term)
Hide Description [Not Specified]
Time Frame up to 15 weeks
Hide Outcome Measure Data
Hide Analysis 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).
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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
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.
Overall Number of Participants Analyzed 28 23
Mean (Standard Deviation)
Unit of Measure: Stem Cell Collection Attempts
1.4  (0.8) 1.1  (0.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Exercise
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA
Statistical Test of Hypothesis P-Value <0.025
Comments Bonferroni adjusted p-value for multiple comparisons.
Method ANOVA
Comments This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.
6.Primary Outcome
Title Number of Stem Cell Collection Attempts (Long Term)
Hide Description [Not Specified]
Time Frame up to 30 weeks
Hide Outcome Measure Data
Hide Analysis 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).
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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
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.
Overall Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: Stem Cell Collection Attempts
1.3  (0.6) 1.1  (0.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Exercise
Comments The null hypothesis was that there would be no difference between groups for the number of stem cell collection attempts.
Type of Statistical Test Non-Inferiority or Equivalence
Comments ANOVA
Statistical Test of Hypothesis P-Value <0.025
Comments Bonferroni adjusted p-value for multiple comparisons.
Method ANOVA
Comments This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.
7.Primary Outcome
Title Total Number of Days of Stem Cell Collection (Short Term)
Hide Description [Not Specified]
Time Frame up to 15 weeks
Hide Outcome Measure Data
Hide Analysis 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).
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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
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.
Overall Number of Participants Analyzed 28 23
Mean (Standard Deviation)
Unit of Measure: Days
5.3  (4.0) 4.0  (2.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Exercise
Comments The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.
Type of Statistical Test Non-Inferiority or Equivalence
Comments T-test and chi-squared to check for equivalence of groups for age, race and gender.
Statistical Test of Hypothesis P-Value <0.025
Comments Bonferroni adjusted p-value for multiple comparisons.
Method ANOVA
Comments This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.
8.Primary Outcome
Title Total Number of Days of Stem Cell Collection (Long Term)
Hide Description [Not Specified]
Time Frame up to 30 weeks
Hide Outcome Measure Data
Hide Analysis 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).
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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
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.
Overall Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: Days
4.9  (3.1) 4.5  (3.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Exercise
Comments The null hypothesis was that there would be no difference between groups for the number of days of stem cell collections.
Type of Statistical Test Non-Inferiority or Equivalence
Comments T-test and chi-squared to check for equivalence of groups for age, race and gender.
Statistical Test of Hypothesis P-Value <0.025
Comments Bonferroni adjusted p-value for multiple comparisons.
Method ANOVA
Comments This is minus 9 (4 exercise, 5 usual care) participants who were unresponsive to Epoetin Alfa and included participants in short and long study.
9.Secondary Outcome
Title Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
Hide Description Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.
Time Frame up to 15 weeks
Hide Outcome Measure Data
Hide Analysis 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).
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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
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.
Overall Number of Participants Analyzed 28 23
Mean (Standard Deviation)
Unit of Measure: g/dl
Baseline 12.1  (1.6) 11.6  (1.7)
Before transplantation 10.8  (1.5) 11.0  (1.6)
During transplantation 10.1  (0.7) 10.4  (0.9)
At discharge 10.6  (1.4) 10.6  (1.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Usual Care, Exercise
Comments The null hypothesis was that there would be no difference between groups for the number of platelet transfusions.
Type of Statistical Test Non-Inferiority or Equivalence
Comments T-test and chi-squared to check for equivalence of groups for age, race and gender.
Statistical Test of Hypothesis P-Value <0.025
Comments Bonferroni adjusted p-value for multiple comparisons.
Method ANOVA
Comments [Not Specified]
10.Secondary Outcome
Title Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
Hide Description Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.
Time Frame up to 30 weeks
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Hide Analysis 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).
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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
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.
Overall Number of Participants Analyzed 34 35
Mean (Standard Deviation)
Unit of Measure: g/dl
Baseline 11.5  (1.8) 11.7  (1.8)
Before Transplantation 12.0  (1.6) 12.0  (1.4)
During Transplanation 10.8  (1.1) 10.8  (1.1)
At Discharge 10.9  (1.4) 11.0  (1.3)
Time Frame up to 30 weeks
Adverse Event Reporting Description All participants included in the Short and Long Term Analysis populations. Other (non-serious)Adverse Events were not collected for this study.
 
Arm/Group Title Usual Care Exercise
Hide Arm/Group 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 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.
All-Cause Mortality
Usual Care Exercise
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Usual Care Exercise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   17/62 (27.42%)      25/58 (43.10%)    
Blood and lymphatic system disorders     
Anemia  1/62 (1.61%)  1/58 (1.72%) 
Hyponatremia  1/62 (1.61%)  5/58 (8.62%) 
Cardiac disorders     
Atrial fibrillation  0/62 (0.00%)  1/58 (1.72%) 
Myocardial infarction  0/62 (0.00%)  1/58 (1.72%) 
Gastrointestinal disorders     
Mucositis / diarrhea  1/62 (1.61%)  1/58 (1.72%) 
Ruptured diverticulum  0/62 (0.00%)  1/58 (1.72%)  59
General disorders     
Death  1/62 (1.61%)  1/58 (1.72%) 
Dehydration  2/62 (3.23%)  1/58 (1.72%) 
Fluid overload  1/62 (1.61%)  0/58 (0.00%) 
Pain  1/62 (1.61%)  1/58 (1.72%) 
Syncope  1/62 (1.61%)  0/58 (0.00%) 
Immune system disorders     
Neutropenic fever  11/62 (17.74%)  8/58 (13.79%) 
Infections and infestations     
Infection / sepsis  5/62 (8.06%)  1/58 (1.72%) 
Pneumonia  5/62 (8.06%)  1/58 (1.72%) 
Rectal abcesses  1/62 (1.61%)  0/58 (0.00%) 
Metabolism and nutrition disorders     
Hyperglycemia  3/62 (4.84%)  3/58 (5.17%) 
Musculoskeletal and connective tissue disorders     
Compression fracture  0/62 (0.00%)  1/58 (1.72%) 
Renal and urinary disorders     
Renal failure  1/62 (1.61%)  0/58 (0.00%) 
Renal stone  1/62 (1.61%)  0/58 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory distress  1/62 (1.61%)  0/58 (0.00%) 
Vascular disorders     
Deep Vein Thrombosis (DVT)  11/62 (17.74%)  10/58 (17.24%) 
Pulmonary embolus  3/62 (4.84%)  2/58 (3.45%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Usual Care Exercise
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
Patients with hemoglobin <8 g/dl received RBC transfusions according to the transplantation protocol. Analysis may have missed specific disease-related influences on hemoglobin. Randomization should have distributed disease risks equally for groups.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Elizabeth Ann Coleman
Organization: University of Arkansas for Medical Sciences
Phone: 501-661-7902
Responsible Party: Elizabeth Ann Coleman, PhD, RNP, AOCN, University of Arkansas for Medical Sciences
ClinicalTrials.gov Identifier: NCT00577096     History of Changes
Other Study ID Numbers: IRB # 29287
R01NR008937 ( U.S. NIH Grant/Contract )
Ortho Biotech Clinical Affairs ( Other Identifier: Ortho Biotech Clinical Affairs )
First Submitted: December 17, 2007
First Posted: December 19, 2007
Results First Submitted: March 17, 2011
Results First Posted: April 21, 2011
Last Update Posted: April 6, 2015