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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00400686
Recruitment Status : Completed
First Posted : November 17, 2006
Results First Posted : December 9, 2016
Last Update Posted : February 22, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
The Cleveland Clinic

Brief 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.

Condition or disease Intervention/treatment Phase
Anemia Multiple Myeloma Plasma Cell Neoplasm Biological: epoetin alfa Not Applicable

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2003
Actual Primary Completion Date : January 2009
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400686

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

Responsible Party: The Cleveland Clinic Identifier: NCT00400686     History of Changes
Other Study ID Numbers: CASE-CCF-5497
P30CA043703 ( U.S. NIH Grant/Contract )
CASE-CCF-5497 ( Other Identifier: Cleveland Clinic )
ORTHO-CASE-CCF-5497 ( Other Identifier: Cleveland Clinic )
First Posted: November 17, 2006    Key Record Dates
Results First Posted: December 9, 2016
Last Update Posted: February 22, 2018
Last Verified: January 2018

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

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