Effects of Exercise in Combination With Epoetin Alfa

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

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

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Ortho Biotech Clinical Affairs, L.L.C.

  collaborator INDUSTRY

• University of Arkansas

  lead OTHER

Principal Investigators

• Sharon K Coon · University of Oklahoma

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2001-10-31

Primary Completion

2004-06-30

Completion

2004-06-30

Countries

• United States

Study Locations