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


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Not Enrolling
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Multiple Myeloma

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome 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.

Outcome Time Frame:

up to 15 weeks

Safety Issue:

Yes

Principal Investigator

Sharon K Coon

Investigator Role:

Study Director

Investigator Affiliation:

University of Oklahoma

Authority:

United States: Institutional Review Board

Study ID:

IRB # 29287

NCT ID:

NCT00577096

Start Date:

October 2001

Completion Date:

June 2004

Related Keywords:

  • Multiple Myeloma
  • multiple myeloma
  • polysomnography
  • quality of life
  • exercise
  • Multiple Myeloma
  • Neoplasms, Plasma Cell

Name

Location

University of Arkansas for Medical Sciences Little Rock, Arkansas  72205