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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00400686
First received: November 16, 2006
Last updated: October 18, 2016
Last verified: October 2016
  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
Anemia
Multiple Myeloma
Plasma Cell Neoplasm
Biological: epoetin alfa

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • Change From Baseline in Hemoglobin at Day 28 [ Time Frame: Baseline to Day 28 ]
    Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.

  • Number of Patients With an at Least 1gm/dL Increase in Hgb [ Time Frame: Baseline to Day 28 ]
  • Number of Patients With an at Least 2gm/dL Increase in Hgb [ Time Frame: Baseline to Day 28 ]

Enrollment: 31
Study Start Date: September 2003
Study Completion Date: August 2013
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Epoetin Alfa - 80,000 U sc
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
Biological: epoetin alfa
Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
The Cleveland Clinic
National Cancer Institute (NCI)
Investigators
Study Chair: Ronald M. Sobecks, MD Case Comprehensive Cancer Center
  More Information

Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00400686     History of Changes
Other Study ID Numbers: CASE-CCF-5497
P30CA043703 ( US NIH Grant/Contract Award Number )
CASE-CCF-5497 ( Other Identifier: Cleveland Clinic )
ORTHO-CASE-CCF-5497 ( Other Identifier: Cleveland Clinic )
Study First Received: November 16, 2006
Results First Received: June 3, 2015
Last Updated: October 18, 2016

Keywords provided by The Cleveland Clinic:
anemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Anemia
Plasmacytoma
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Epoetin Alfa
Hematinics

ClinicalTrials.gov processed this record on April 28, 2017