NCT00577096

Effects of Exercise in Combination With Epoetin Alfa

Effects of Exercise in Combination With Epoetin Alfa During High-Dose Chemotherapy and Autologous Peripheral Blood Stem Cell Transplantation for Multiple Myeloma

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2001-10-01
• Primary completion: 2004-06-01
• Completion: 2004-06-01
• First posted: 2007-12-19
• Last updated: 2015-04-06
• Results posted: 2011-04-21

Locations

1 site across 1 country: United States