Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma

Study Overview
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Brief Summary
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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 works in treating anemia in patients undergoing chemotherapy for multiple myeloma.

Detailed Description
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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 a less frequent maintenance dose of epoetin alfa in multiple myeloma patients. Secondary Determine the effect of moderate anemia on quality of life in these patients. Correlate changes in hemoglobin levels with changes in quality of life in patients treated with this drug. Determine the effect of this drug on transfusion requirements after day 28 in these patients. OUTLINE: This is an open-label, non-randomized, pilot study. Patients receive high-dose epoetin alfa subcutaneously (SC) once a week for 4 weeks or until their hemoglobin levels reach 12-13 g/dL. Patients then receive epoetin alfa SC once every 2 weeks for 8 weeks OR once a week for 4 weeks, and then once every 2 weeks for 8 weeks (as long as their hemoglobin levels remain between 12-13 g/dL). Patients then receive maintenance epoetin alfa SC once every 4 weeks for up to 12 weeks. Patients whose hemoglobin level decreases by 1-1.5 g/dL return to previous epoetin alfa schedule. Patients whose hemoglobin level is < 9 g/dL after returning to the previous schedule may receive epoetin alfa for an additional 24 weeks. Quality of life is assessed at baseline and at weeks 2, 4, 8, 16, and 24 weeks during treatment. After completion of study treatment, patients are followed periodically for survival. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Official Title
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A Single Institution, Open-Label, Nonrandomized Pilot Study of High Dose Epoetin Alfa Administered Once a Week in Patients With Multiple Myeloma: Its Effects on Hemoglobin, Blood Transfusion Requirements and Quality of Life

Conditions
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Multiple Myeloma, Plasma Cell Neoplasm, Anemia

Intervention / Treatment
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* Biological: epoetin alfa


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin Alfa - 80,000 U sc<br>Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels | Biological: epoetin alfa<br>* Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Hemoglobin at Day 28 | Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa. | Baseline to Day 28 | 
| Number of Patients With an at Least 1gm/dL Increase in Hgb |  | Baseline to Day 28 | 
| Number of Patients With an at Least 2gm/dL Increase in Hgb |  | Baseline to Day 28 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma