CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Epoetin Alfa +14 moredrug
Likely dose
Epoetin Alfa 150 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00577096
NCT00577096N/ACompleted

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

University of Arkansas·interventional·Posted Dec 19, 2007·Updated Apr 6, 2015

In Brief

A clinical study evaluating Epoetin Alfa, Exercise, and 7 other interventions for Multiple Myeloma. Completed, enrolled 120 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2007
Enrollment StartOct 1, 2001
Primary CompletionJun 1, 2004
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.5 years ago

Interventions

Epoetin Alfadrug

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.

Exercisebehavioral

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

Autologous Peripheral Blood Stem Cell Transplantationbiological

Standard PBSCT for multiple myeloma

Red Blood Cell Transfusionbiological

RBC Transfusion was administered as needed

Thalidomidedrug

Fifty percent of the participants received 400 mg daily

Heparin, Low-Molecular-Weightdrug

Patients who received thalidomide also received prophylactic low molecular weight heparin

Platelet Transfusionbiological

Platelet transfusions were administered as needed

Melphalandrug

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

Epoetin Alfadrug

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 IIdrug

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 Transfusionbiological

RBC Transfusion was administered as needed

Thalidomidedrug

Fifty percent of participants received 400 mg daily

Heparin, Low-Molecular-Weightdrug

Patients who received thalidomide also received prophylactic low molecular weight heparin

Platelet Transfusionbiological

Platelet transfusions were administered as needed

Melphalandrug

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