Effects of Exercise in Combination With Epoetin Alfa - Full Text View

Purpose

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.

Condition	Intervention
Multiple Myeloma	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

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma

Resource links provided by NLM:

Further study details as provided by University of Arkansas:

Primary Outcome Measures:

Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term) [ Time Frame: up to 15 weeks ] [ Designated as safety issue: Yes ]
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) [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term) [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
Number of Stem Cell Collection Attempts (Short Term) [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
Number of Stem Cell Collection Attempts (Long Term) [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
Total Number of Days of Stem Cell Collection (Short Term) [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
Total Number of Days of Stem Cell Collection (Long Term) [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term) [ Time Frame: up to 15 weeks ] [ Designated as safety issue: No ]
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) [ Time Frame: up to 30 weeks ] [ Designated as safety issue: No ]
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.

Enrollment:	120
Study Start Date:	October 2001
Study Completion Date:	June 2004
Primary Completion Date:	June 2004 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 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)	Drug: Epoetin Alfa 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. Other Name: EPO Behavioral: Exercise A home-based individualized exercise program that incorporated aerobic and strength resistance training. Other Name: Exercise Biological: Autologous Peripheral Blood Stem Cell Transplantation Standard PBSCT for multiple myeloma Other Name: (PBSCT) Biological: Red Blood Cell Transfusion RBC Transfusion was administered as needed Other Name: (RBC) Drug: Thalidomide Fifty percent of the participants received 400 mg daily Other Name: Thalidomide Drug: Heparin, Low-Molecular-Weight Patients who received thalidomide also received prophylactic low molecular weight heparin Other Name: Heparin, Low-Molecular-Weight Biological: Platelet Transfusion Platelet transfusions were administered as needed Other Name: Platelet Transfusion Drug: Melphalan Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma Other Name: Melphalan
Active Comparator: 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)	Drug: Epoetin Alfa 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 Other Name: EPO Drug: Total Therapy II 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. Other Names: vincristine doxorubicin dexamethasone cyclophosphamide etoposide cisplatin Biological: Red Blood Cell Transfusion RBC Transfusion was administered as needed Other Name: RBC Drug: Thalidomide Fifty percent of participants received 400 mg daily Other Name: Thalidomide Drug: Heparin, Low-Molecular-Weight Patients who received thalidomide also received prophylactic low molecular weight heparin Other Name: Heparin, Low-Molecular-Weight Biological: Platelet Transfusion Platelet transfusions were administered as needed Other Name: Platelet Transfusion Drug: Melphalan Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma Other Name: Melphalan

Arms

Assigned Interventions

Experimental: 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)

Drug: Epoetin Alfa

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.

Other Name: EPO

Behavioral: Exercise

A home-based individualized exercise program that incorporated aerobic and strength resistance training.

Other Name: Exercise

Biological: Autologous Peripheral Blood Stem Cell Transplantation

Standard PBSCT for multiple myeloma

Other Name: (PBSCT)

Biological: Red Blood Cell Transfusion

RBC Transfusion was administered as needed

Other Name: (RBC)

Drug: Thalidomide

Fifty percent of the participants received 400 mg daily

Other Name: Thalidomide

Drug: Heparin, Low-Molecular-Weight

Patients who received thalidomide also received prophylactic low molecular weight heparin

Other Name: Heparin, Low-Molecular-Weight

Biological: Platelet Transfusion

Platelet transfusions were administered as needed

Other Name: Platelet Transfusion

Drug: Melphalan

Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma

Other Name: Melphalan

Active Comparator: 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)

Drug: Epoetin Alfa

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

Other Name: EPO

Drug: Total Therapy II

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.

Other Names:

vincristine
doxorubicin
dexamethasone
cyclophosphamide
etoposide
cisplatin

Biological: Red Blood Cell Transfusion

RBC Transfusion was administered as needed

Other Name: RBC

Drug: Thalidomide

Fifty percent of participants received 400 mg daily

Other Name: Thalidomide

Drug: Heparin, Low-Molecular-Weight

Patients who received thalidomide also received prophylactic low molecular weight heparin

Other Name: Heparin, Low-Molecular-Weight

Biological: Platelet Transfusion

Platelet transfusions were administered as needed

Other Name: Platelet Transfusion

Drug: Melphalan

Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma

Other Name: Melphalan

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00577096

Locations

United States, Arkansas
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205

Sponsors and Collaborators

University of Arkansas

National Institutes of Health (NIH)

Ortho Biotech Clinical Affairs, L.L.C.

Investigators

Study Director:

Sharon K Coon

University of Oklahoma

More Information

No publications provided

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, Ortho Biotech Clinical Affairs
Study First Received:	December 17, 2007
Results First Received:	March 17, 2011
Last Updated:	April 21, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Arkansas:

multiple myeloma
polysomnography
quality of life
exercise

Additional relevant MeSH terms:

Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Cisplatin

Cyclophosphamide
Dexamethasone
Doxorubicin
Etoposide
Melphalan
Thalidomide
Vincristine
Dexamethasone acetate
Dexamethasone 21-phosphate
BB 1101
Epoetin Alfa
Heparin
Calcium heparin
Heparin, Low-Molecular-Weight
Dalteparin

ClinicalTrials.gov processed this record on June 18, 2013