N/A
N=135
Effects of Exercise in Combination With Epoetin Alfa
Multiple Myeloma
Bottom Line
View on ClinicalTrials.gov: NCT00577096 ↗Enrolled (actual)
135
Serious AEs
35.0%
Results posted
Apr 2011
Primary outcome: Primary: Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term) — 2.3; 1.8 RBC Transfusions — p=<0.025
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Epoetin Alfa (Drug); Exercise (Behavioral); Autologous Peripheral Blood Stem Cell Transplantation (Biological); Red Blood Cell Transfusion (Biological); Thalidomide (Drug); Heparin, Low-Molecular-Weight (Drug); Platelet Transfusion (Biological); Melphalan (Drug); Total Therapy II (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Jun 2004
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Short Term) |
2.3; 1.8 | <0.025 sig |
| PRIMARY Number of Red Blood Cell Transfusions Needed to Maintain Hemoglobin Levels (Long Term) |
1.8; 1.0 | <0.025 sig |
| PRIMARY Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets.(Short Term) |
3.1; 2.3 | <0.025 sig |
| PRIMARY Number of Platelet Transfusions Needed to Maintain Adequate Number of Platelets. (Long Term) |
3.6; 2.0 | <0.025 sig |
| PRIMARY Number of Stem Cell Collection Attempts (Short Term) |
1.4; 1.1 | <0.025 sig |
| PRIMARY Number of Stem Cell Collection Attempts (Long Term) |
1.3; 1.1 | <0.025 sig |
| PRIMARY Total Number of Days of Stem Cell Collection (Short Term) |
5.3; 4.0 | <0.025 sig |
| PRIMARY Total Number of Days of Stem Cell Collection (Long Term) |
4.9; 4.5 | <0.025 sig |
| SECONDARY Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Short Term) |
12.1; 11.6; 10.8; 11.0; 10.1; 10.4 | <0.025 sig |
| SECONDARY Hemoglobin Levels Before Chemotherapy and During Transplantation Period (Long Term) |
11.5; 11.7; 12.0; 12.0; 10.8; 10.8 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00577096). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.