Effects of Exercise in Combination With Epoetin Alfa

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

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.

Study Overview

• Status: Completed
• Conditions: Multiple Myeloma
• Intervention / Treatment: 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: Thalidomide; Drug: Total Therapy II

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: EPO; Behavioral: Exercise; A home-based individualized exercise program that incorporated aerobic and strength resistance training.; Biological: Autologous Peripheral Blood Stem Cell Transplantation; Standard PBSCT for multiple myeloma; Other Names: (PBSCT); Biological: Red Blood Cell Transfusion; RBC Transfusion was administered as needed; Other Names: RBC; Drug: Thalidomide; Fifty percent of the participants received 400 mg daily; Drug: Heparin, Low-Molecular-Weight; Patients who received thalidomide also received prophylactic low molecular weight heparin; Biological: Platelet Transfusion; Platelet transfusions were administered as needed; Drug: Melphalan; Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma; 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 Names: EPO; Drug: Thalidomide; Fifty percent of participants received 400 mg daily
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 og body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl.; Other Names: EPO; Biological: Red Blood Cell Transfusion; RBC Transfusion was administered as needed; Other Names: RBC; Drug: Thalidomide; Fifty percent of the participants received 400 mg daily; Drug: Heparin, Low-Molecular-Weight; Patients who received thalidomide also received prophylactic low molecular weight heparin; Biological: Platelet Transfusion; Platelet transfusions were administered as needed; Drug: Melphalan; Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma; 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 Names: EPO; Drug: Thalidomide; Fifty percent of participants received 400 mg daily; 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: cisplatin; cyclophosphamide; dexamethasone; doxorubicin; etoposide; vincristine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Arkansas
• Collaborators: National Institutes of Health (NIH); Ortho Biotech Clinical Affairs, L.L.C.
• Investigators: Study Director: Sharon K Coon, University of Oklahoma

Study record dates

Study Major Dates

• Study Start: October 1, 2001
• Primary Completion (Actual): June 1, 2004
• Study Completion (Actual): June 1, 2004

Study Registration Dates

• First Submitted: December 17, 2007
• First Submitted That Met QC Criteria: December 18, 2007
• First Posted (Estimate): December 19, 2007

Study Record Updates

• Last Update Posted (Estimate): April 6, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: polysomnography; exercise; quality of life; multiple myeloma
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Multiple Myeloma; Neoplasms, Plasma Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Antibiotics, Antineoplastic; Anticoagulants; Hematinics; Dexamethasone; Cyclophosphamide; Etoposide; Cisplatin; Thalidomide; Heparin; Epoetin Alfa; Melphalan; Doxorubicin; Calcium heparin; Vincristine; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: IRB # 29287; R01NR008937 (U.S. NIH Grant/Contract); Ortho Biotech Clinical Affairs (Other Identifier: Ortho Biotech Clinical Affairs)