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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

December 17, 2007
April 21, 2011
October 2001
June 2004   (final data collection date for primary outcome measure)
  • 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 ]
Primary outcome measure of the Home-Based Individualized Exercise Program (HBIEP) and polysomnography to explore the effects of the HBIEP on sleep stages in a sub-sample [ Time Frame: varies with each participant, participation is Test 1:Baseline-before starting chemotherapy, Test 2:Before CAD and stem cell collection, Test 3: After stem cell collection and before DCEP ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00577096 on ClinicalTrials.gov Archive Site
  • 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.
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Not Provided
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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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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 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
  • 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
  • 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)
    Interventions:
    • 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
  • 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)
    Interventions:
    • Drug: Epoetin Alfa
    • Drug: Total Therapy II
    • Biological: Red Blood Cell Transfusion
    • Drug: Thalidomide
    • Drug: Heparin, Low-Molecular-Weight
    • Biological: Platelet Transfusion
    • Drug: Melphalan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2004
June 2004   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00577096
IRB # 29287, R01NR008937, Ortho Biotech Clinical Affairs
Yes
Elizabeth Ann Coleman, PhD, RNP, AOCN, University of Arkansas for Medical Sciences
University of Arkansas
  • National Institutes of Health (NIH)
  • Ortho Biotech Clinical Affairs, L.L.C.
Study Director: Sharon K Coon University of Oklahoma
University of Arkansas
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP