Effects of Exercise in Combination With Epoetin Alfa

This study has been completed.
Sponsor:
Collaborators:
Ortho Biotech Clinical Affairs, L.L.C.
Information provided by:
University of Arkansas
ClinicalTrials.gov Identifier:
NCT00577096
First received: December 17, 2007
Last updated: April 21, 2011
Last verified: April 2011
  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

  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
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 April 15, 2014