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

NeuroTherapia, Inc.

Status: Completed

Conditions: Anemia; Multiple Myeloma; Plasma Cell Neoplasm

Treatments: Biological: epoetin alfa

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00400686

P30CA043703 (U.S. NIH Grant/Contract)

CASE-CCF-5497 (Other Identifier)

ORTHO-CASE-CCF-5497 (Other Identifier)

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

• 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Epoetin Alfa - 80,000 U sc

Experimental group

Description:

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

Treatment:

Biological: epoetin alfa