Effects of Exercise in Combination With Epoetin Alfa

This study has been completed.
Sponsor:
Collaborators:
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00577096
First received: December 17, 2007
Last updated: April 21, 2011
Last verified: April 2011
Results First Received: March 17, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: 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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

Participant Flow for 2 periods

Period 1:   Short Term Participation
    Usual Care     Exercise  
STARTED     69     66  
COMPLETED     62     58  
NOT COMPLETED     7     8  
withdrew from multiple myeloma treatment                 3                 2  
Withdrawal by Subject                 3                 5  
Death                 1                 1  

Period 2:   Long Term Participation
    Usual Care     Exercise  
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.



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.
Total Total of all reporting groups

Baseline Measures
    Usual Care     Exercise     Total  
Number of Participants  
[units: participants]
  69     66     135  
Age  
[units: years]
Mean ± Standard Deviation
     
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  
Gender, Customized  
[units: 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  
[units: 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  
[units: participants]
     
United States     69     66     135  



  Outcome Measures
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1.  Primary:   Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)   [ Time Frame: up to 15 weeks ]

2.  Primary:   Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)   [ Time Frame: up to 30 weeks ]

3.  Primary:   Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)   [ Time Frame: up to 15 weeks ]

4.  Primary:   Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)   [ Time Frame: up to 30 weeks ]

5.  Primary:   Number of Stem Cell Collection Attempts (Short Term)   [ Time Frame: up to 15 weeks ]

6.  Primary:   Number of Stem Cell Collection Attempts (Long Term)   [ Time Frame: up to 30 weeks ]

7.  Primary:   Total Number of Days of Stem Cell Collection (Short Term)   [ Time Frame: up to 15 weeks ]

8.  Primary:   Total Number of Days of Stem Cell Collection (Long Term)   [ Time Frame: up to 30 weeks ]

9.  Secondary:   Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)   [ Time Frame: up to 15 weeks ]

10.  Secondary:   Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)   [ Time Frame: up to 30 weeks ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.  


Results Point of Contact:  
Name/Title: Elizabeth Ann Coleman
Organization: University of Arkansas for Medical Sciences
phone: 501-661-7902
e-mail: colemanelizabetha@uams.edu


No publications provided


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, Ortho Biotech Clinical Affairs
Study First Received: December 17, 2007
Results First Received: March 17, 2011
Last Updated: April 21, 2011
Health Authority: United States: Institutional Review Board