Effects of Exercise in Combination With Epoetin Alfa

NACompletedINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

October 31, 2001

Primary Completion Date

June 30, 2004

Study Completion Date

June 30, 2004

Conditions
Multiple Myeloma
Interventions
DRUG

Epoetin Alfa

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.

BEHAVIORAL

Exercise

A home-based individualized exercise program that incorporated aerobic and strength resistance training.

BIOLOGICAL

Autologous Peripheral Blood Stem Cell Transplantation

Standard PBSCT for multiple myeloma

BIOLOGICAL

Red Blood Cell Transfusion

RBC Transfusion was administered as needed

DRUG

Thalidomide

Fifty percent of the participants received 400 mg daily

DRUG

Heparin, Low-Molecular-Weight

Patients who received thalidomide also received prophylactic low molecular weight heparin

BIOLOGICAL

Platelet Transfusion

Platelet transfusions were administered as needed

DRUG

Melphalan

Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma

DRUG

Epoetin Alfa

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

DRUG

Total Therapy II

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.

BIOLOGICAL

Red Blood Cell Transfusion

RBC Transfusion was administered as needed

DRUG

Thalidomide

Fifty percent of participants received 400 mg daily

DRUG

Heparin, Low-Molecular-Weight

Patients who received thalidomide also received prophylactic low molecular weight heparin

BIOLOGICAL

Platelet Transfusion

Platelet transfusions were administered as needed

DRUG

Melphalan

Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma

Trial Locations (1)

72205

University of Arkansas for Medical Sciences, Little Rock

All Listed Sponsors
collaborator

National Institutes of Health (NIH)

NIH

collaborator

Ortho Biotech Clinical Affairs, L.L.C.

INDUSTRY

lead

University of Arkansas

OTHER

NCT00577096 - Effects of Exercise in Combination With Epoetin Alfa | Biotech Hunter | Biotech Hunter