Epoetin Alfa in Treating Anemia in Patients Undergoing Chemotherapy for Multiple Myeloma - Full Text View

Sponsored by:	Case Comprehensive Cancer Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00400686

Purpose

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.

Condition	Intervention
Cancer-Related Problem/Condition Multiple Myeloma and Plasma Cell Neoplasm	Biological: epoetin alfa

Genetics Home Reference related topics: aceruloplasminemia hemophilia

MedlinePlus related topics: Anemia Blood Transfusion and Donation Cancer Multiple Myeloma

Drug Information available for: Erythropoietin Epoetin alfa

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Non-Randomized, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	50
Study Start Date:	March 2005

Detailed 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400686

Locations

United States, Ohio
Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422

Sponsors and Collaborators

Case Comprehensive Cancer Center

Investigators

Study Chair:

Ronald M. Sobecks, MD

Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000447139, CASE-CCF-5497, ORTHO-CASE-CCF-5497
Study First Received:	November 16, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00400686 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

anemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Study placed in the following topic categories:

Epoetin Alfa
Immunoproliferative Disorders
Hematinics
Blood Protein Disorders
Hematologic Diseases
Blood Coagulation Disorders
Anemia
Vascular Diseases

Quality of Life
Paraproteinemias
Hemostatic Disorders
Multiple Myeloma
Hemorrhagic Disorders
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

Additional relevant MeSH terms:

Epoetin Alfa
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Hematinics
Blood Protein Disorders
Hematologic Diseases
Hematologic Agents
Vascular Diseases
Paraproteinemias

Hemostatic Disorders
Pharmacologic Actions
Multiple Myeloma
Neoplasms
Hemorrhagic Disorders
Therapeutic Uses
Cardiovascular Diseases
Lymphoproliferative Disorders
Neoplasms, Plasma Cell

ClinicalTrials.gov processed this record on May 06, 2009