Effects of Exercise in Combination With Epoetin Alfa

Not Applicable

Completed

Conditions: Multiple Myeloma

Interventions: Drug: Epoetin Alfa
Behavioral: Exercise
Drug: Total Therapy II
Biological: Autologous Peripheral Blood Stem Cell Transplantation
Biological: Red Blood Cell Transfusion
Drug: Thalidomide
Drug: Heparin, Low-Molecular-Weight
Biological: Platelet Transfusion
Drug: Melphalan

Registration Number: NCT00577096

Lead Sponsor: University of Arkansas

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 120

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise	Autologous Peripheral Blood Stem Cell Transplantation	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)
Exercise	Heparin, Low-Molecular-Weight	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)
Exercise	Exercise	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)
Exercise	Red Blood Cell Transfusion	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)
Exercise	Platelet Transfusion	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)
usual care	Red Blood Cell Transfusion	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)
usual care	Platelet Transfusion	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)
usual care	Heparin, Low-Molecular-Weight	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)
usual care	Total Therapy II	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)
usual care	Thalidomide	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)
usual care	Epoetin Alfa	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)
Exercise	Epoetin Alfa	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)
Exercise	Thalidomide	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)
Exercise	Melphalan	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)
usual care	Melphalan	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)

Primary Outcome Measures

Name	Time	Method
Number of Stem Cell Collection Attempts (Short Term)	up to 15 weeks
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)	up to 15 weeks	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.
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)	up to 30 weeks	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.
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 (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

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