Overview

Effects of Exercise in Combination With Epoetin Alfa

Status:
Completed
Trial end date:
2004-06-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Arkansas
Collaborators:
National Institutes of Health (NIH)
Ortho Biotech Clinical Affairs, L.L.C.
Treatments:
BB 1101
Calcium heparin
Cisplatin
Cyclophosphamide
Dalteparin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Doxorubicin
Epoetin Alfa
Etoposide
Heparin
Heparin, Low-Molecular-Weight
Liposomal doxorubicin
Melphalan
Thalidomide
Tinzaparin
Vincristine
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.