120
Participants
Start Date
October 31, 2001
Primary Completion Date
June 30, 2004
Study Completion Date
June 30, 2004
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.
Exercise
A home-based individualized exercise program that incorporated aerobic and strength resistance training.
Autologous Peripheral Blood Stem Cell Transplantation
Standard PBSCT for multiple myeloma
Red Blood Cell Transfusion
RBC Transfusion was administered as needed
Thalidomide
Fifty percent of the participants received 400 mg daily
Heparin, Low-Molecular-Weight
Patients who received thalidomide also received prophylactic low molecular weight heparin
Platelet Transfusion
Platelet transfusions were administered as needed
Melphalan
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
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
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.
Red Blood Cell Transfusion
RBC Transfusion was administered as needed
Thalidomide
Fifty percent of participants received 400 mg daily
Heparin, Low-Molecular-Weight
Patients who received thalidomide also received prophylactic low molecular weight heparin
Platelet Transfusion
Platelet transfusions were administered as needed
Melphalan
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
University of Arkansas for Medical Sciences, Little Rock
National Institutes of Health (NIH)
NIH
Ortho Biotech Clinical Affairs, L.L.C.
INDUSTRY
University of Arkansas
OTHER