Clinical trial NCT00400686: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anemia
Multiple Myeloma
Plasma Cell Neoplasm
Keywords: anemia
stage I multiple myeloma
stage II multiple myeloma
stage III multiple myeloma
refractory multiple myeloma
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2006-11-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change From Baseline in Hemoglobin at Day 28
timeFrame: Baseline to Day 28
measure: Number of Patients With an at Least 1gm/dL Increase in Hgb
timeFrame: Baseline to Day 28
measure: Number of Patients With an at Least 2gm/dL Increase in Hgb
timeFrame: Baseline to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Ronald M. Sobecks, MD
role: STUDY_CHAIR
References: