Effects of Exercise in Combination With Epoetin Alfa

Study Overview
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Brief Summary
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The purpose of the study was to determine the effect of Epoetin alfa therapy (short term versus long term) with and without a home-based individualized exercise program that incorporated aerobic and strength resistance training for patients being treated with high-dose chemotherapy and autologous peripheral bloodstem cell transplantation (PBSC T) for multiple myeloma. The endpoints for the study included the number of attempts at and total number of days of stem cell collection, number of RBC and platelet transfusions during the transplantation period, time-to-recovery after transplantation, and response to intensive therapy for multiple myeloma.

Official Title
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Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma

Conditions
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Multiple Myeloma

Intervention / Treatment
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* 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: Epoetin Alfa
* Drug: Total Therapy II
* Biological: Red Blood Cell Transfusion
* Drug: Thalidomide
* Drug: Heparin, Low-Molecular-Weight
* Biological: Platelet Transfusion
* Drug: Melphalan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Those who were not at high risk for impending pathologic fracture or cord compression, as determined by magnetic resonance imaging and other radiology reports and physician assessments,and enrolled in Total Therapy treatment protocols were invited to participate in the study. Exclusion Criteria: Patients were excluded if they showed any of the following attributes/conditions: Inability to understand the intent of the study Current diagnosis with a major psychiatric illness Presence of microcytic or macrocytic anemia Uncontrolled hypertension Red cell transfusions within 2 weeks; and Recombinant epoetin alfa within 8 weeks of study enrollment.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>Study participants were computer randomized to an individualized exercise program. Participants were stratified within Arm according to whether or not they received thalidomide with heparin, and by age (60 and younger versus older than 60) | Drug: Epoetin Alfa<br>* Epoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual dose is 150 units/kg og body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl.<br>* Other names: EPO;Behavioral: Exercise<br>* A home-based individualized exercise program that incorporated aerobic and strength resistance training.<br>Biological: Autologous Peripheral Blood Stem Cell Transplantation<br>* Standard PBSCT for multiple myeloma<br>* Other names: (PBSCT);Biological: Red Blood Cell Transfusion<br>* RBC Transfusion was administered as needed<br>* Other names: (RBC);Drug: Thalidomide<br>* Fifty percent of the participants received 400 mg daily<br>Drug: Heparin, Low-Molecular-Weight<br>* Patients who received thalidomide also received prophylactic low molecular weight heparin<br>Biological: Platelet Transfusion<br>* Platelet transfusions were administered as needed<br>Drug: Melphalan<br>* Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma<br>|
| Active Comparator: usual care<br>Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified within Arm according to whether or not they received thalidomide with heparin, and by age (60 and younger versus older than 60) | Drug: Epoetin Alfa<br>* Epoetin alfa was administered per an IRB approved algorithm to study participants when hemoglobin levels dropped during high dose chemotherapy. The usual 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<br>* Other names: EPO;Drug: Total Therapy II<br>* Standard Induction chemotherapy care included: vincristine, doxorubicin, and dexamethasone (VAD) (0.5 mg, 10 mg/m2, and 40 mg, respectively);dexamethasone, cyclophosphamide,etoposide, and cisplatin (DCEP) (40 mg, 400 mg/m2, 40 mg/m2, and 15 mg/m2,respectively); and cyclophosphamide,doxorubicin, and dexamethasone (CAD) (750 mg/m2, 15 mg/m2, and 40 mg, respectively) for mobilization.<br>* Other names: cisplatin;Biological: Red Blood Cell Transfusion<br>* RBC Transfusion was administered as needed<br>* Other names: RBC;Drug: Thalidomide<br>* Fifty percent of participants received 400 mg daily<br>Drug: Heparin, Low-Molecular-Weight<br>* Patients who received thalidomide also received prophylactic low molecular weight heparin<br>Biological: Platelet Transfusion<br>* Platelet transfusions were administered as needed<br>Drug: Melphalan<br>* Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term) | 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. | up to 15 weeks | 
| Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term) | 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. | up to 30 weeks | 
| Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term) |  | up to 15 weeks | 
| Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term) |  | up to 30 weeks | 
| Number of Stem Cell Collection Attempts (Short Term) |  | up to 15 weeks | 
| Number of Stem Cell Collection Attempts (Long Term) |  | up to 30 weeks | 
| Total Number of Days of Stem Cell Collection (Short Term) |  | up to 15 weeks | 
| Total Number of Days of Stem Cell Collection (Long Term) |  | up to 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term) | Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge. | up to 15 weeks | 
| Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term) | Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge. | up to 30 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multiple myeloma, polysomnography, quality of life, exercise