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

NCT00400686 | Completed Results

• 3 other identifiers: CASE-CCF-5497P30CA043703ORTHO-CASE-CCF-5497
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Anemia; Multiple Myeloma; Plasma Cell Neoplasm

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Change From Baseline in Hemoglobin at Day 28

  Change from baseline in hemoglobin after treatment with high-dose Epoetin Alfa.

  Baseline to Day 28

• Number of Patients With an at Least 1gm/dL Increase in Hgb

  Baseline to Day 28

• Number of Patients With an at Least 2gm/dL Increase in Hgb

  Baseline to Day 28

Study Arms (1)

Epoetin Alfa - 80,000 U sc

EXPERIMENTAL

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

Interventions

epoetin alfa BIOLOGICAL

Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1.

Epoetin Alfa - 80,000 U sc

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Anemia; Multiple Myeloma; Neoplasms, Plasma Cell

Interventions

Epoetin Alfa

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Beth Faiman, MSN,CNP, AOCN
• Organization: Cleveland Clinic

faimanb@ccf.org

216-445-3738

Study Officials

• Ronald M. Sobecks, MD

  Case Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2006
• First Posted: November 17, 2006
• Study Start: September 1, 2003
• Primary Completion: January 1, 2009
• Study Completion: August 1, 2013
• Last Updated: February 22, 2018
• Results First Posted: December 9, 2016

Record last verified: 2018-01

Locations

US (1)