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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

  Participant Flow

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

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 
Overall Participants Analyzed 
[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

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

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

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

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

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

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

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

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

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

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


  Serious Adverse Events


  Other Adverse Events


  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.


  More Information

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.


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



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