Effects of Exercise in Combination With Epoetin Alfa

NCT00577096 | Completed Results DMC

• 3 other identifiers: IRB # 29287R01NR008937Ortho Biotech Clinical Affairs
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Myeloma

Keywords

multiple myeloma; polysomnography; quality of life; exercise

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (2)

• Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)

  up to 15 weeks

• Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)

  up to 30 weeks

Study Arms (2)

Exercise

EXPERIMENTAL

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; 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

usual care

ACTIVE COMPARATOR

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; Drug: Total Therapy II; Biological: Red Blood Cell Transfusion; Drug: Thalidomide; Drug: Heparin, Low-Molecular-Weight; Biological: Platelet Transfusion; Drug: Melphalan

Interventions

Epoetin Alfa DRUG

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.

Also known as: EPO

Exercise

Exercise BEHAVIORAL

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

Exercise

Autologous Peripheral Blood Stem Cell Transplantation BIOLOGICAL

Standard PBSCT for multiple myeloma

Also known as: (PBSCT)

Exercise

Red Blood Cell Transfusion BIOLOGICAL

RBC Transfusion was administered as needed

Also known as: (RBC)

Exercise

Thalidomide DRUG

Fifty percent of the participants received 400 mg daily

Exercise

Heparin, Low-Molecular-Weight DRUG

Patients who received thalidomide also received prophylactic low molecular weight heparin

Exercise

Platelet Transfusion BIOLOGICAL

Platelet transfusions were administered as needed

Exercise

Melphalan DRUG

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

Exercise

Total Therapy II DRUG

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.

Also known as: vincristine, doxorubicin, dexamethasone, cyclophosphamide, etoposide, cisplatin

usual care

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arkansas: lead
• National Institutes of Health (NIH): collaborator
• Ortho Biotech Clinical Affairs, L.L.C.: collaborator

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Multiple Myeloma; Motor Activity

Interventions

Epoetin Alfa; Exercise; Peripheral Blood Stem Cell Transplantation; Erythrocyte Transfusion; Thalidomide; Heparin, Low-Molecular-Weight; Platelet Transfusion; Melphalan; Vincristine; Doxorubicin; Dexamethasone; Cyclophosphamide; Etoposide; Cisplatin

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative; Blood Component Transfusion; Blood Transfusion; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heparin; Glycosaminoglycans; Polysaccharides; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Indoles; Indolizidines; Indolizines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Phosphoramide Mustards; Phosphoramides; Organophosphorus Compounds; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Glucosides; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Limitations and Caveats

Patients with hemoglobin \<8 g/dl received RBC transfusions according to the transplantation protocol. Analysis may have missed specific disease-related influences on hemoglobin. Randomization should have distributed disease risks equally for groups.

Results Point of Contact

• Title: Elizabeth Ann Coleman
• Organization: University of Arkansas for Medical Sciences

colemanelizabetha@uams.edu

501-661-7902

Study Officials

• Sharon K Coon

  University of Oklahoma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 17, 2007
• First Posted: December 19, 2007
• Study Start: October 1, 2001
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: April 6, 2015
• Results First Posted: April 21, 2011

Record last verified: 2015-04

Locations

US (1)