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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
120
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.
A home-based individualized exercise program that incorporated aerobic and strength resistance training.
Standard PBSCT for multiple myeloma
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term)
The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.
Time frame: up to 15 weeks
Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term)
The targeted hemoglobin level for each participant was 10-12 g/dl. This is the number of red blood cell (RBC) transfusions administered to participants, as part of the investigational therapy algorithm, in an attempt to alleviate the anemia caused by multiple myeloma and high-dose chemotherapy. The numbers of RBC and platelet transfusions were obtained from the University of Arkansas for Medical Sciences blood bank.
Time frame: up to 30 weeks
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)
Time frame: up to 15 weeks
Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)
Time frame: up to 30 weeks
Number of Stem Cell Collection Attempts (Short Term)
Time frame: up to 15 weeks
Number of Stem Cell Collection Attempts (Long Term)
Time frame: up to 30 weeks
Total Number of Days of Stem Cell Collection (Short Term)
Time frame: up to 15 weeks
Total Number of Days of Stem Cell Collection (Long Term)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
RBC Transfusion was administered as needed
Fifty percent of the participants received 400 mg daily
Patients who received thalidomide also received prophylactic low molecular weight heparin
Platelet transfusions were administered as needed
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
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
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.
RBC Transfusion was administered as needed
Fifty percent of participants received 400 mg daily
Patients who received thalidomide also received prophylactic low molecular weight heparin
Platelet transfusions were administered as needed
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
Time frame: up to 30 weeks
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term)
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), During PBSCT and at hospital discharge.
Time frame: up to 15 weeks
Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term)
Hemoglobin Levels were measured at baseline, before peripheral blood stem cell transplantation (PBSCT), during PBSCT and at hospital discharge.
Time frame: up to 30 weeks