Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Stem Cell Collection Attempts (Short Term)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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)
干预措施: Epoetin Alfa (Drug)
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)
干预措施: Exercise (Behavioral)
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)
干预措施: Autologous Peripheral Blood Stem Cell Transplantation (Biological)
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)
干预措施: Red Blood Cell Transfusion (Biological)
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)
干预措施: Thalidomide (Drug)
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)
干预措施: Heparin, Low-Molecular-Weight (Drug)
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)
干预措施: Platelet Transfusion (Biological)
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)
干预措施: Melphalan (Drug)
usual care
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)
干预措施: Epoetin Alfa (Drug)
usual care
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)
干预措施: Total Therapy II (Drug)
usual care
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)
干预措施: Red Blood Cell Transfusion (Biological)
usual care
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)
干预措施: Thalidomide (Drug)
usual care
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)
干预措施: Heparin, Low-Molecular-Weight (Drug)
usual care
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)
干预措施: Platelet Transfusion (Biological)
usual care
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)
干预措施: Melphalan (Drug)
结局指标
主要结局
Number of Stem Cell Collection Attempts (Short Term)
时间窗: up to 15 weeks
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
时间窗: 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)
时间窗: 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)
时间窗: up to 15 weeks
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
时间窗: up to 30 weeks
Number of Stem Cell Collection Attempts (Long Term)
时间窗: up to 30 weeks
Total Number of Days of Stem Cell Collection (Short Term)
时间窗: up to 15 weeks
Total Number of Days of Stem Cell Collection (Long Term)
时间窗: up to 30 weeks
次要结局
- Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)(up to 30 weeks)
- Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)(up to 15 weeks)