Effects of Exercise in Combination With Epoetin Alfa

University of Arkansas

Status

Completed

Conditions

Multiple Myeloma

Treatments

Biological: Red Blood Cell Transfusion

Drug: Epoetin Alfa

Drug: Thalidomide

Behavioral: Exercise

Drug: Melphalan

Biological: Autologous Peripheral Blood Stem Cell Transplantation

Drug: Total Therapy II

Drug: Heparin, Low-Molecular-Weight

Biological: Platelet Transfusion

Study type

Interventional

Funder types

Other

Industry

NIH

Identifiers

NCT00577096

Ortho Biotech Clinical Affairs (Other Identifier)

R01NR008937 (U.S. NIH Grant/Contract)

IRB # 29287

Details and patient eligibility

About

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.

Enrollment

120 patients

Sex

All

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

120 participants in 2 patient groups

Exercise

Experimental group

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)

Treatment:

Biological: Autologous Peripheral Blood Stem Cell Transplantation

Biological: Red Blood Cell Transfusion

Drug: Epoetin Alfa

Drug: Melphalan

Biological: Red Blood Cell Transfusion

Biological: Platelet Transfusion

Drug: Heparin, Low-Molecular-Weight

Drug: Thalidomide

Drug: Melphalan

Biological: Platelet Transfusion

Behavioral: Exercise

Drug: Thalidomide

Drug: Epoetin Alfa

usual care

Active Comparator group

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)

Treatment:

Biological: Red Blood Cell Transfusion

Drug: Epoetin Alfa

Drug: Melphalan

Biological: Red Blood Cell Transfusion

Biological: Platelet Transfusion

Drug: Heparin, Low-Molecular-Weight

Drug: Total Therapy II

Drug: Heparin, Low-Molecular-Weight

Drug: Thalidomide

Drug: Melphalan

Biological: Platelet Transfusion