Effects of Exercise in Combination With Epoetin Alfa

Multiple Myeloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00577096
• Other study ID #: IRB # 29287
• Secondary ID: R01NR008937Ortho
• Status: Completed
• Phase: N/A
• First received: December 17, 2007
• Last updated: April 2, 2015
• Start date: October 2001
• Est. completion date: June 2004

Study information

• Verified date: April 2015
• Source: University of Arkansas
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 2004
• Est. primary completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Those who were not at high risk for impending pathologic fracture or cord compression, as determined by magnetic resonance imaging and other radiology reports and physician assessments,and enrolled in Total Therapy treatment protocols were invited to participate in the study.

Exclusion Criteria:

Patients were excluded if they showed any of the following attributes/conditions:

• Inability to understand the intent of the study

• Current diagnosis with a major psychiatric illness

• Presence of microcytic or macrocytic anemia

• Uncontrolled hypertension

• Red cell transfusions within 2 weeks; and

• Recombinant epoetin alfa within 8 weeks of study enrollment.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

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
• Red Blood Cell Transfusion
RBC Transfusion was administered as needed

Drug:
• 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

Biological:
• Platelet Transfusion
Platelet transfusions were administered as needed

Drug:
• 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.

Biological:
• Red Blood Cell Transfusion
RBC Transfusion was administered as needed

Drug:
• Thalidomide
Fifty percent of participants received 400 mg daily
• 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

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas

Sponsors (3)

Lead Sponsor	Collaborator
University of Arkansas	National Institutes of Health (NIH), Ortho Biotech Clinical Affairs, L.L.C.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 15 weeks	Yes
Primary	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.	up to 30 weeks	No
Primary	Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term)		up to 15 weeks	No
Primary	Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term)		up to 30 weeks	No
Primary	Number of Stem Cell Collection Attempts (Short Term)		up to 15 weeks	No
Primary	Number of Stem Cell Collection Attempts (Long Term)		up to 30 weeks	No
Primary	Total Number of Days of Stem Cell Collection (Short Term)		up to 15 weeks	No
Primary	Total Number of Days of Stem Cell Collection (Long Term)		up to 30 weeks	No
Secondary	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.	up to 15 weeks	No
Secondary	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.	up to 30 weeks	No