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Completed

NCT Number: NCT00577096

Effects of Exercise in Combination With Epoetin Alfa

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: EPO

Exercise

Behavioral

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

Autologous Peripheral Blood Stem Cell Transplantation

Biological

Standard PBSCT for multiple myeloma

Other names: (PBSCT)

red blood cell transfusion

Biological

RBC Transfusion was administered as needed

Other names: (RBC)

thalidomide

Drug

Fifty percent of the participants received 400 mg daily

Heparin, Low-Molecular-Weight

Drug

Patients who received thalidomide also received prophylactic low molecular weight heparin

Platelet Transfusion

Biological

Platelet transfusions were administered as needed

melphalan

Drug

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

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.

Other names: vincristine, doxorubicin, dexamethasone, cyclophosphamide, etoposide, cisplatin

Primary outcomes

  1. Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)

    Time frame: 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.

  2. Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)

    Time frame: 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.

  3. Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)

    Time frame: up to 15 weeks

  4. Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)

    Time frame: up to 30 weeks

  5. Number of Stem Cell Collection Attempts (Short Term)

    Time frame: up to 15 weeks

  6. Number of Stem Cell Collection Attempts (Long Term)

    Time frame: up to 30 weeks

  7. Total Number of Days of Stem Cell Collection (Short Term)

    Time frame: up to 15 weeks

  8. Total Number of Days of Stem Cell Collection (Long Term)

    Time frame: up to 30 weeks

Secondary outcomes

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

    Time frame: up to 15 weeks

    Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.

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

    Time frame: up to 30 weeks

    Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Collaborators

  • National Institutes of Health (NIH)
  • Ortho Biotech Clinical Affairs, L.L.C.

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2004
Study completion
2004
First posted
Dec 19, 2007
Registry last updated
Apr 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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