Overview

This trial is active, not recruiting.

Conditions anemia, multiple myeloma and plasma cell neoplasm
Treatment epoetin alfa
Sponsor The Cleveland Clinic
Collaborator National Cancer Institute (NCI)
Start date March 2005
End date January 2009
Trial size 50 participants
Trial identifier NCT00400686, CASE-CCF-5497, ORTHO-CASE-CCF-5497, P30CA043703

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 works in treating anemia in patients undergoing chemotherapy for multiple myeloma.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model single group assignment
Masking open label
Primary purpose supportive care

Primary Outcomes

Measure
Efficacy of epoetin alfa as measured by hematologic response and transfusion requirements
time frame: 24 weeks

Secondary Outcomes

Measure
Quality of life as assessed by the Functional Assessment of Cancer Therapy Scales for Anemia (FACT-An) at baseline and at 4, 8, 16, and 24 weeks during treatment
time frame: 24 weeks.

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Description OBJECTIVES: Primary - 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. 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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2010.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.