Status:
COMPLETED
Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Anemia
Multiple Myeloma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Epoetin alfa may cause the body to make more red blood cells. It is used to treat anemia in patients with multiple myeloma. PURPOSE: This clinical trial is studying how well epoetin alfa w...
Detailed Description
OBJECTIVES: Primary * Determine the hematologic response and transfusion requirements of chemotherapy-related moderate anemia to the administration of a high initial dose of epoetin alfa followed by...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed multiple myeloma (MM)
- Requiring active therapy for MM
- Planning to undergo chemotherapy for ≥ 3 months
- Moderate anemia caused by MM and/or chemotherapy, as evidenced by hemoglobin ≤ 11.0 g/dL
- No untreated anemia predominantly due to factors other than MM/chemotherapy (i.e., iron or folate deficiencies, hemolysis, HIV, or gastrointestinal bleeding)
- PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-3
- Life expectancy ≥ 6 months
- Transferrin saturation ≥ 20%
- Ferritin ≥ 100 ng/mL
- Homocysteine normal (concurrent vitamin supplementation allowed)
- Methylmalonic acid normal (concurrent vitamin supplementation allowed)
- Renal function normal
- No uncontrolled hypertension
- No prior thrombotic events unless treated with appropriate prophylaxis
- No known hypersensitivity to mammalian cell-derived products
- No uncontrolled infection
- No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- Weight \< 100 Kg
- Patients with iron, folate, or vitamin B\_12 deficiency allowed provided conditions are corrected prior to study entry
- Able to read and understand English at a 7th grade level
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior total lymphoid, extensive abdominal, or inverted Y radiotherapy
- Concurrent red blood cell transfusion allowed provided hemoglobin ≤ 7 g/dL AND patient is symptomatic
- Concurrent vitamin supplementation allowed for cyanocobalamin (vitamin B\_12) or folate deficiency
Exclusion
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2013
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00400686
Start Date
September 1 2003
End Date
August 1 2013
Last Update
February 22 2018
Active Locations (1)
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1
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065