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Effects of Exercise in Combination With Epoetin Alfa

Primary Purpose

Multiple Myeloma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Epoetin Alfa
Exercise
Autologous Peripheral Blood Stem Cell Transplantation
Red Blood Cell Transfusion
Thalidomide
Heparin, Low-Molecular-Weight
Platelet Transfusion
Melphalan
Epoetin Alfa
Total Therapy II
Red Blood Cell Transfusion
Thalidomide
Heparin, Low-Molecular-Weight
Platelet Transfusion
Melphalan
Sponsored by
University of Arkansas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring multiple myeloma, polysomnography, quality of life, exercise

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Arkansas for Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Exercise

usual care

Arm Description

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)

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)

Outcomes

Primary Outcome Measures

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.
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.
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
Number of Stem Cell Collection Attempts (Short Term)
Number of Stem Cell Collection Attempts (Long Term)
Total Number of Days of Stem Cell Collection (Short Term)
Total Number of Days of Stem Cell Collection (Long Term)

Secondary Outcome Measures

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.
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.

Full Information

First Posted
December 17, 2007
Last Updated
April 2, 2015
Sponsor
University of Arkansas
Collaborators
National Institutes of Health (NIH), Ortho Biotech Clinical Affairs, L.L.C.
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1. Study Identification

Unique Protocol Identification Number
NCT00577096
Brief Title
Effects of Exercise in Combination With Epoetin Alfa
Official Title
Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
June 2004 (Actual)
Study Completion Date
June 2004 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Arkansas
Collaborators
National Institutes of Health (NIH), Ortho Biotech Clinical Affairs, L.L.C.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
Keywords
multiple myeloma, polysomnography, quality of life, exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise
Arm Type
Experimental
Arm Description
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)
Arm Title
usual care
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Epoetin Alfa
Other Intervention Name(s)
EPO
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
A home-based individualized exercise program that incorporated aerobic and strength resistance training.
Intervention Type
Biological
Intervention Name(s)
Autologous Peripheral Blood Stem Cell Transplantation
Other Intervention Name(s)
(PBSCT)
Intervention Description
Standard PBSCT for multiple myeloma
Intervention Type
Biological
Intervention Name(s)
Red Blood Cell Transfusion
Other Intervention Name(s)
(RBC)
Intervention Description
RBC Transfusion was administered as needed
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
Fifty percent of the participants received 400 mg daily
Intervention Type
Drug
Intervention Name(s)
Heparin, Low-Molecular-Weight
Intervention Description
Patients who received thalidomide also received prophylactic low molecular weight heparin
Intervention Type
Biological
Intervention Name(s)
Platelet Transfusion
Intervention Description
Platelet transfusions were administered as needed
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
Intervention Type
Drug
Intervention Name(s)
Epoetin Alfa
Other Intervention Name(s)
EPO
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Total Therapy II
Other Intervention Name(s)
vincristine, doxorubicin, dexamethasone, cyclophosphamide, etoposide, cisplatin
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Red Blood Cell Transfusion
Other Intervention Name(s)
RBC
Intervention Description
RBC Transfusion was administered as needed
Intervention Type
Drug
Intervention Name(s)
Thalidomide
Intervention Description
Fifty percent of participants received 400 mg daily
Intervention Type
Drug
Intervention Name(s)
Heparin, Low-Molecular-Weight
Intervention Description
Patients who received thalidomide also received prophylactic low molecular weight heparin
Intervention Type
Biological
Intervention Name(s)
Platelet Transfusion
Intervention Description
Platelet transfusions were administered as needed
Intervention Type
Drug
Intervention Name(s)
Melphalan
Intervention Description
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
Primary Outcome Measure Information:
Title
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
Description
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.
Time Frame
up to 15 weeks
Title
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
Description
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.
Time Frame
up to 30 weeks
Title
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
Time Frame
up to 15 weeks
Title
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
Time Frame
up to 30 weeks
Title
Number of Stem Cell Collection Attempts (Short Term)
Time Frame
up to 15 weeks
Title
Number of Stem Cell Collection Attempts (Long Term)
Time Frame
up to 30 weeks
Title
Total Number of Days of Stem Cell Collection (Short Term)
Time Frame
up to 15 weeks
Title
Total Number of Days of Stem Cell Collection (Long Term)
Time Frame
up to 30 weeks
Secondary Outcome Measure Information:
Title
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
Description
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.
Time Frame
up to 15 weeks
Title
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
Description
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.
Time Frame
up to 30 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon K Coon
Organizational Affiliation
University of Oklahoma
Official's Role
Study Director
Facility Information:
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States

12. IPD Sharing Statement

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Effects of Exercise in Combination With Epoetin Alfa

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