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

Primary Purpose

Anemia, Multiple Myeloma, Plasma Cell Neoplasm

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

epoetin alfa

About this trial

This is an interventional supportive care trial for Anemia focused on measuring anemia, stage I multiple myeloma, stage II multiple myeloma, stage III multiple myeloma, refractory multiple myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epoetin Alfa - 80,000 U sc

Arm 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

Outcomes

Primary Outcome Measures

Change From Baseline in Hemoglobin at 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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT00400686

First Posted

November 16, 2006

Last Updated

January 24, 2018

Sponsor

The Cleveland Clinic

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00400686

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

September 2003 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Cleveland Clinic

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Anemia, Multiple Myeloma, Plasma Cell Neoplasm

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

31 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Epoetin Alfa - 80,000 U sc

Arm Type

Experimental

Arm 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

Intervention Type

Biological

Intervention Name(s)

epoetin alfa

Intervention Description

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

Primary Outcome Measure Information:

Title

Change From Baseline in Hemoglobin at Day 28

Description

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

Time Frame

Baseline to Day 28

Title

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

Time Frame

Baseline to Day 28

Title

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

Time Frame

Baseline to Day 28

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald M. Sobecks, MD

Organizational Affiliation

Case Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

Case Comprehensive Cancer Center

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106-5065

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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