Multiple Myeloma Clinical Trial
Official title:
Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma
Verified date | April 2015 |
Source | University of Arkansas |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | June 2004 |
Est. primary completion date | June 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | University of Arkansas for Medical Sciences | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas | National Institutes of Health (NIH), Ortho Biotech Clinical Affairs, L.L.C. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term) | 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. | up to 15 weeks | Yes |
Primary | Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term) | 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. | up to 30 weeks | No |
Primary | Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term) | up to 15 weeks | No | |
Primary | Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term) | up to 30 weeks | No | |
Primary | Number of Stem Cell Collection Attempts (Short Term) | up to 15 weeks | No | |
Primary | Number of Stem Cell Collection Attempts (Long Term) | up to 30 weeks | No | |
Primary | Total Number of Days of Stem Cell Collection (Short Term) | up to 15 weeks | No | |
Primary | Total Number of Days of Stem Cell Collection (Long Term) | up to 30 weeks | No | |
Secondary | Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term) | Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge. | up to 15 weeks | No |
Secondary | Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term) | Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge. | up to 30 weeks | No |
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