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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

18 Years
Open (Enrolling)
Anemia, Multiple Myeloma and Plasma Cell Neoplasm

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Trial Information

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



- Determine the efficacy of high-dose epoetin alfa followed by maintenance epoetin alfa
in treating moderate anemia, in terms of hematologic response and transfusion
requirements, in patients who are undergoing chemotherapy for multiple myeloma.


- 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

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

After completion of study treatment, patients are followed periodically for survival.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

Inclusion Criteria


- 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

- No untreated anemia predominantly due to factors other than MM/chemotherapy (i.e.,
iron or folate deficiencies, hemolysis, HIV, or gastrointestinal bleeding)


- 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


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Efficacy of epoetin alfa as measured by hematologic response and transfusion requirements

Outcome Time Frame:

24 weeks

Safety Issue:


Principal Investigator

Ronald M. Sobecks, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Case Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2005

Completion Date:

Related Keywords:

  • Anemia
  • Multiple Myeloma and Plasma Cell Neoplasm
  • anemia
  • stage I multiple myeloma
  • stage II multiple myeloma
  • stage III multiple myeloma
  • refractory multiple myeloma
  • Anemia
  • Neoplasms
  • Multiple Myeloma
  • Neoplasms, Plasma Cell
  • Plasmacytoma



Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065