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NCT00577096 · REGISTRY CONDITION SEARCH

Effects of Exercise in Combination With Epoetin Alfa

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2015-04-06

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Number of Stem Cell Collection Attempts (Short Term)

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outcome · POSTED

Number of Stem Cell Collection Attempts (Long Term)

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

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

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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.
healthy Volunteers
false
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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)
    intervention Names
    1. Drug: Epoetin Alfa
    2. Behavioral: Exercise
    3. Biological: Autologous Peripheral Blood Stem Cell Transplantation
    4. Biological: Red Blood Cell Transfusion
    5. Drug: Thalidomide
    6. Drug: Heparin, Low-Molecular-Weight
    7. Biological: Platelet Transfusion
    8. Drug: Melphalan
    label
    Exercise
    type
    EXPERIMENTAL
  2. description
    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)
    intervention Names
    1. Drug: Epoetin Alfa
    2. Drug: Total Therapy II
    3. Biological: Red Blood Cell Transfusion
    4. Drug: Thalidomide
    5. Drug: Heparin, Low-Molecular-Weight
    6. Biological: Platelet Transfusion
    7. Drug: Melphalan
    label
    usual care
    type
    ACTIVE_COMPARATOR
interventions
  1. arm Group Labels
    1. Exercise
    description
    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.
    name
    Epoetin Alfa
    other Names
    1. EPO
    type
    DRUG
  2. arm Group Labels
    1. Exercise
    description
    A home-based individualized exercise program that incorporated aerobic and strength resistance training.
    name
    Exercise
    type
    BEHAVIORAL
  3. arm Group Labels
    1. Exercise
    description
    Standard PBSCT for multiple myeloma
    name
    Autologous Peripheral Blood Stem Cell Transplantation
    other Names
    1. (PBSCT)
    type
    BIOLOGICAL
  4. arm Group Labels
    1. Exercise
    description
    RBC Transfusion was administered as needed
    name
    Red Blood Cell Transfusion
    other Names
    1. (RBC)
    type
    BIOLOGICAL
  5. arm Group Labels
    1. Exercise
    description
    Fifty percent of the participants received 400 mg daily
    name
    Thalidomide
    type
    DRUG
  6. arm Group Labels
    1. Exercise
    description
    Patients who received thalidomide also received prophylactic low molecular weight heparin
    name
    Heparin, Low-Molecular-Weight
    type
    DRUG
  7. arm Group Labels
    1. Exercise
    description
    Platelet transfusions were administered as needed
    name
    Platelet Transfusion
    type
    BIOLOGICAL
  8. arm Group Labels
    1. Exercise
    description
    Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
    name
    Melphalan
    type
    DRUG
  9. arm Group Labels
    1. usual care
    description
    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
    name
    Epoetin Alfa
    other Names
    1. EPO
    type
    DRUG
  10. arm Group Labels
    1. usual care
    description
    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.
    name
    Total Therapy II
    other Names
    1. vincristine
    2. doxorubicin
    3. dexamethasone
    4. cyclophosphamide
    5. etoposide
    6. cisplatin
    type
    DRUG
  11. arm Group Labels
    1. usual care
    description
    RBC Transfusion was administered as needed
    name
    Red Blood Cell Transfusion
    other Names
    1. RBC
    type
    BIOLOGICAL
  12. arm Group Labels
    1. usual care
    description
    Fifty percent of participants received 400 mg daily
    name
    Thalidomide
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
SUPPORTIVE_CARE
Enrollment
count
120
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
    time Frame
    up to 15 weeks
  2. description
    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.
    measure
    Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
    time Frame
    up to 30 weeks
  3. measure
    Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
    time Frame
    up to 15 weeks
  4. measure
    Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
    time Frame
    up to 30 weeks
  5. measure
    Number of Stem Cell Collection Attempts (Short Term)
    time Frame
    up to 15 weeks
  6. measure
    Number of Stem Cell Collection Attempts (Long Term)
    time Frame
    up to 30 weeks
  7. measure
    Total Number of Days of Stem Cell Collection (Short Term)
    time Frame
    up to 15 weeks
  8. measure
    Total Number of Days of Stem Cell Collection (Long Term)
    time Frame
    up to 30 weeks
secondary Outcomes
  1. description
    Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.
    measure
    Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
    time Frame
    up to 15 weeks
  2. description
    Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.
    measure
    Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
    time Frame
    up to 30 weeks
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice