Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2001-10-31
2004-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Exercise
Study participants were computer randomized to an individualized exercise program. Participants were stratified within Arm according to whether or not they received thalidomide with heparin, and by age (60 and younger versus older than 60)
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.
Exercise
A home-based individualized exercise program that incorporated aerobic and strength resistance training.
Autologous Peripheral Blood Stem Cell Transplantation
Standard PBSCT for multiple myeloma
Red Blood Cell Transfusion
RBC Transfusion was administered as needed
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
Platelet Transfusion
Platelet transfusions were administered as needed
Melphalan
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
usual care
Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified within Arm according to whether or not they received thalidomide with heparin, and by age (60 and younger versus older than 60)
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.
Red Blood Cell Transfusion
RBC Transfusion was administered as needed
Thalidomide
Fifty percent of participants received 400 mg daily
Heparin, Low-Molecular-Weight
Patients who received thalidomide also received prophylactic low molecular weight heparin
Platelet Transfusion
Platelet transfusions were administered as needed
Melphalan
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
Interventions
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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.
Exercise
A home-based individualized exercise program that incorporated aerobic and strength resistance training.
Autologous Peripheral Blood Stem Cell Transplantation
Standard PBSCT for multiple myeloma
Red Blood Cell Transfusion
RBC Transfusion was administered as needed
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
Platelet Transfusion
Platelet transfusions were administered as needed
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.
Red Blood Cell Transfusion
RBC Transfusion was administered as needed
Thalidomide
Fifty percent of participants received 400 mg daily
Heparin, Low-Molecular-Weight
Patients who received thalidomide also received prophylactic low molecular weight heparin
Platelet Transfusion
Platelet transfusions were administered as needed
Melphalan
Administered with autologous peripheralblood stem cell transplantation (PBSCT) for multiple myeloma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
ALL
No
Sponsors
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National Institutes of Health (NIH)
NIH
Ortho Biotech Clinical Affairs, L.L.C.
INDUSTRY
University of Arkansas
OTHER
Responsible Party
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University of Arkansas for Medical Sciences
Principal Investigators
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Sharon K Coon
Role: STUDY_DIRECTOR
University of Oklahoma
Locations
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University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
Countries
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Other Identifiers
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Ortho Biotech Clinical Affairs
Identifier Type: OTHER
Identifier Source: secondary_id
IRB # 29287
Identifier Type: -
Identifier Source: org_study_id
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