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

Inclusion Criteria

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:

- 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